ISO DIS 80369-6 - Small Bore Connectors for Liquids and Gases in Healthcare Applications - Part 6-...

© ISO 2014

ISO/CEN PARALLEL PROCESSINGThis draft has been developed within the International Organization for Standardization (ISO), and processed under the ISO lead mode of collaboration as defined in the Vienna Agreement.

This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel five month enquiry.

Should this draft be accepted, a final draft, established on the basis of comments received, will be submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

To expedite distribution, this document is circulated as received from the committee secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at publication stage.

Small bore connectors for liquids and gases in healthcare applications —Part 6: Connectors for neuraxial applicationsRaccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé —Partie 6: Raccords destinés à des applications neuraxiales

Reference numberISO/DIS 80369-6:2014(E)

DRAFT INTERNATIONAL STANDARDISO/DIS 80369-6

THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.

IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.

RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.

ISO/TC 210 Voting begins on:

2014-09-04

Secretariat: ANSI Voting terminates on: 2015-02-04

ICS: 11.040.25

ISO/DIS 80369-6:2014(E)

ii © ISO 2014 – All rights reserved

Copyright notice

This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, without prior written permission being secured.

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Violators may be prosecuted.

ISO/IEC DIS 80369-6

© ISO/IEC 2014 – All rights reserved iii

Contents Page 1

Foreword ........................................................................................................................................................ iv 2

Introduction .................................................................................................................................................... vi 3

1 Scope .................................................................................................................................................. 1 4

2 Normative references ......................................................................................................................... 1 5

3 Terms and definitions ........................................................................................................................ 2 6

4 General requirements ........................................................................................................................ 3 7

4.1 General requirements for the neuraxial APPLICATION ........................................................................ 3 8

4.2 Material used for SMALL-BORE CONNECTORS ....................................................................................... 4 9

4.3 Compatibility ...................................................................................................................................... 4 10

4.3.1 Compatibility with substances used................................................................................................. 4 11

4.3.2 Biocompatibility ................................................................................................................................. 4 12

5 Dimensional requirements for SMALL-BORE CONNECTORS for neuraxial APPLICATIONS ..................... 4 13

6 Performance requirements ................................................................................................................ 4 14

6.1 General performance requirements .................................................................................................. 4 15

6.2 Fluid leakage ...................................................................................................................................... 5 16

6.2.1 Fluid leakage requirement ................................................................................................................. 5 17

6.2.2 Leakage by pressure decay .............................................................................................................. 5 18

6.2.3 Positive pressure liquid leakage ....................................................................................................... 5 19

6.3 Subatmospheric-pressure air leakage .............................................................................................. 5 20

6.4 Stress cracking .................................................................................................................................. 5 21

6.5 Resistance to separation from axial load ......................................................................................... 5 22

6.6 Resistance to separation from unscrewing ..................................................................................... 6 23

6.7 Resistance to overriding ................................................................................................................... 6 24

Annex A (informative) Rationale and guidance ............................................................................................. 7 25

ANNEX B (normative) * SMALL-BORE CONNECTORS for neuraxial APPLICATIONS ............................................. 11 26

ANNEX C (normative) Reference CONNECTORS for testing SMALL-BORE CONNECTORS for neuraxial 27

APPLICATIONS ...................................................................................................................................... 21 28

Annex D (informative) Assessment of MEDICAL DEVICES and their attributes with CONNECTIONS within 29

this APPLICATION ................................................................................................................................ 27 30

ANNEX E (informative) Summary of the usability requirements for SMALL-BORE CONNECTORS for 31

neuraxial APPLICATIONS ..................................................................................................................... 29 32

Annex F (informative) Summary of SMALL-BORE CONNECTOR criteria and requirements for neuraxial 33

APPLICATIONS ...................................................................................................................................... 33 34

ANNEX G (informative) Summary of assessment of the design of the SMALL BORE CONNECTORS for 35

neuraxial APPLICATIONS ..................................................................................................................... 35 36

Annex H (informative) Mechanical tests for verifying NON-INTERCONNECTABLE characteristics ................ 41 37

Annex I (informative) Reference to the Essential Principles ...................................................................... 44 38

Bibliography .................................................................................................................................................. 46 39

Terminology - Alphabetized index of defined terms .................................................................................. 48 40

Annex ZA (informative) Relationship between this Document and the Essential Requirements of EU 41

Directive 93/42/EEC .......................................................................................................................... 49 42

43

ISO/IEC DIS 80369-6

iv © ISO/IEC 2014 – All rights reserved

Foreword 44

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies 45

(ISO member bodies). The work of preparing International Standards is normally carried out through ISO 46

technical committees. Each member body interested in a subject for which a technical committee has been 47

established has the right to be represented on that committee. International organizations, governmental and 48

non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International 49

Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. 50

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. 51

The main task of technical committees is to prepare International Standards. Draft International Standards 52

adopted by the technical committees are circulated to the member bodies for voting. Publication as an 53

International Standard requires approval by at least 75 % of the member bodies casting a vote. 54

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent 55

rights. ISO shall not be held responsible for identifying any or all such patent rights. 56

ISO/IEC 80369-6 was prepared by a Joint Working Group of Technical Committee ISO/TC 210, Quality 57

management and corresponding general aspects for medical devices, IEC/TC 62, Electrical equipment, 58

Subcommittee (SC) D, Electrical equipment in medical practice and CEN/CENELEC TC3/WG 2, Small-bore 59

connectors. 60

This is the first edition of ISO 80369-6. 61

ISO/IEC 80369 consists of the following parts, under the general title Small-bore connectors for liquids and gases 62

in healthcare applications: 63

Part 1: General requirements 64

Part 2: Connectors for breathing systems and driving gases applications 65

Part 3: Connectors for enteral applications 66

Part 4: Connectors for urethral and urinary applications1) 67

Part 5: Connectors for limb cuff inflation applications 68

Part 6: Connectors for neuraxial applications (this standard) 69

Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications 70

In this standard, the following print types are used: 71

Requirements and definitions: roman type. 72

Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text 73

of tables is also in a smaller type. 74

1) Planned but not yet begun as of the date of publication.

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© ISO/IEC 2014 – All rights reserved v

TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL 75

CAPITALS. 76

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the 77

conditions is true. 78

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. 79

For the purposes of this standard, the auxiliary verb: 80

“shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; 81

“should” means that compliance with a requirement or a test is recommended but is not mandatory for 82

compliance with this standard; 83

“may” is used to describe a permissible way to achieve compliance with a requirement or test. 84

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is 85

guidance or rationale related to that item in Annex A. 86

The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers and 87

testing organizations may need a transitional period following publication of a new, amended or revised ISO or 88

IEC publication in which to make products in accordance with the new requirements and to equip themselves for 89

conducting new or revised tests. It is the recommendation of the committees that the content of this publication 90

be adopted for implementation nationally not earlier than 3 years from the date of publication for equipment newly 91

designed and not earlier than 5 years from the date of publication for equipment already in production. 92

93

ISO/IEC DIS 80369-6

vi © ISO/IEC 2014 – All rights reserved

Introduction 94

The standards in this series were developed to prevent misconnection between SMALL-BORE CONNECTORS used in 95

different APPLICATIONS. Part 1 of the series documents the necessary measures and PROCEDURES to prevent 96

misconnection and defines the APPLICATIONS. Part 20 contains the common TEST METHODS to support the 97

functional requirements for SMALL-BORE CONNECTORS. The other parts specify the designs of SMALL-BORE 98

CONNECTORS for each APPLICATION. 99

This part of ISO 80369 includes the dimensions and drawings of CONNECTORS intended to be used in neuraxial 100

APPLICATIONS. Other parts of ISO 80369 include requirements for SMALL-BORE CONNECTORS used in different 101

APPLICATION categories. 102

There is international evidence that ‘wrong-route’ medication errors with neuraxial MEDICAL DEVICES have caused 103

deaths and severe HARM. There are reports of non-epidural medications being administered into the epidural 104

space and local anaesthetic solutions intended for epidural administration being administered by the intravenous 105

route. [1][6][11][12][12][16] There is also a report where an anaesthetic agent for intravenous use was 106

administered into the cerebrospinal fluid via an external ventricular drain [7] and earlier reports of antibiotics being 107

inappropriately administered by this route. 108

In July 2007 the World Health Organisation’s World Alliance For Patient Safety issued Alert 115 describing four 109

incidents in different countries in which vincristine had been accidentally administered by the intrathecal route 110

instead of intravenous route, as intended. [20] The Alert indicated that, since 1968, this same error had been 111

reported 55 times from a variety of institutional settings. 112

These incidents had occurred despite repeated warnings of the RISK and the introduction of extensive labelling 113

requirements and recommendations, intended to standardise practice and reduce RISKS. 114

Other health organisations around the world have also issued detailed guidance to minimise the RISK of these 115

‘wrong-route’ errors. [17][12][18][6] 116

Nevertheless, reports of fatal incidents following the administration of vinca alkaloids continue to be reported 117

internationally. [19] In 2009, the Food and Drug Administration in the USA issued a Medical Devices Calendar 118

which included an example of a case study of a neuraxial misconnection. [9] 119

120

121

DRAFT INTERNATIONAL STANDARD ISO/IEC DIS 80369-6

© ISO/IEC 2014 – All rights reserved 1

Small-bore connectors for liquids and gases in healthcare 122

applications — Part 6: Connectors for neuraxial applications 123

1 * Scope 124

This part of ISO 80369 specifies requirements for SMALL-BORE CONNECTORS intended to be used for CONNECTIONS 125

in neuraxial APPLICATIONS. Neuraxial APPLICATIONS involve the use of MEDICAL DEVICES intended to administer 126

medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures 127

or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes. 128

NOTE 1 Sites for the NEURAXIAL APPLICATION include the spine, intrathecal or subarachnoid space, ventricles of the brain 129

and the epi-, extra-, or peri-dural space. NEURAXIAL APPLICATION anaesthetics can be administered regionally affecting a large 130

part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. 131

NEURAXIAL APPLICATION procedures include continuous infusion of wounds with local anaesthetic agents. 132

NOTE 2 For the purposes of this standard, local anaesthesia injected hypodermically is not considered a neuraxial 133

APPLICATION. 134

EXAMPLES Intended administration includes intrathecal chemotherapy, local anaesthetics, radiological contrast agents, 135

antibiotics, analgesics 136

This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of these 137

SMALL-BORE CONNECTORS intended to be used with MEDICAL DEVICES. This part of ISO 80369 does not specify 138

requirements for the MEDICAL DEVICES or ACCESSORIES that use these CONNECTORS. Such requirements are given 139

in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES. 140

NOTE 3 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this part of ISO 80369 141

into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular MEDICAL DEVICE 142

standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised, requirements for SMALL-BORE 143

CONNECTORS, as specified in this part of ISO 80369, will be included. Furthermore it is recognised that standards need to be 144

developed for many MEDICAL DEVICES used for neuraxial APPLICATIONS. 145

2 Normative references 146

The following referenced documents, in whole or in part, are normatively referenced in this document and are 147

indispensable for the application of this document. For dated references, only the edition cited applies. For 148

undated references, the latest edition of the referenced document (including any amendments) applies. 149

NOTE 1 The way in which these referenced documents are cited in normative requirements determines the extent (in 150

whole or in part) to which they apply. 151

NOTE 2 Informative references are listed in the bibliography on page 46. 152

ISO 10933-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk 153

management process 154

ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General 155

requirements 156

ISO/IEC DIS 80369-6

2 © ISO/IEC 2014 – All rights reserved

ISO 80369-3:— 2), Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors 157

for enteral applications 158


for limb cuff inflation applications 160


with 6% (Luer) taper for intravascular or hypodermic applications 162

ISO 80369-20:— 5), Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common 163

test methods 164

ASTM D638-10, Standard test method for tensile properties of plastics 165

ASTM D790-10, Standard test methods for flexural properties of unreinforced and reinforced plastics and 166

electrical insulating materials 167

3 Terms and definitions 168

For the purpose of this document, the terms and definitions specified in ISO 80369-1 ISO 80369-20:—, 169

ISO 14971:2007 and the following apply. For convenience, the sources of all defined terms used in this document 170

are given in the Index on page 48. 171

3.1 172

LOCK CONNECTOR 173

CONNECTOR with a locking mechanism 174

3.2 175

NORMAL USE 176

operation, including routine inspection and adjustments by any USER, and stand-by, according to the instructions 177

for use 178

NOTE 1 to entry: NORMAL USE should not be confused with INTENDED USE. While both include the concept of use as intended by 179

the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE incorporates not only the medical purpose, 180

but maintenance, service, transport, etc. as well. 181

[SOURCE: IEC 60601-1:2005+A1:2012, definition 3.97, modified, replaced ‘OPERATOR’ with ‘USER’.] 182

3.3 183

RATED 184

<value> term referring to a value assigned by the MANUFACTURER for a specified operating condition 185

[SOURCE: IEC 60601-1:2005, definition 3.97] 186

3.4 187

SLIP CONNECTOR 188

CONNECTOR without a locking mechanism 189

2) To be published.

3) To be published.

4) To be published.

5) To be published.

ISO/IEC DIS 80369-6


3.5 190

USER 191

person using, i.e. operating or handling, the MEDICAL DEVICE 192

NOTE 1 to entry: This includes, but is not limited to, cleaners, maintainers and installers. 193

NOTE 2 to entry: PATIENTS or other laypersons can be USERS. 194

[SOURCE: ISO 62366:2007, definition 3.23] 195

3.6 196

USER PROFILE 197

summary of the mental, physical and demographic traits of an intended USER population, as well as any special 198

characteristics that can have a bearing on design decisions, such as occupational skills and job requirements 199

[SOURCE: ISO 62366:2007, definition 3.25] 200

4 General requirements 201

4.1 General requirements for the neuraxial APPLICATION 202

SMALL-BORE CONNECTORS of MEDICAL DEVICES or ACCESSORIES intended for use in neuraxial APPLICATIONS 203

specified in this standard comply with the general requirements of ISO 80369-1:2010 except as follows. 204

Because the following CONNECTORS are inadequately specified, SMALL-BORE CONNECTORS for use in neuraxial 205

APPLICATIONS should not, but may connect with: 206

the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006; 207

the temperature sensor CONNECTOR and mating ports specified in Annex DD of ISO 8185:2007; and 208

the nipples of EN 13544-2:2002, 209

The reference CONNECTORS for evaluation of the NON-INTERCONNECTABLE characteristics are described in Annex C. 210

The tests of Annex H shall replace ISO 80369-1:2010, Annex B. 211

NOTE 1 ISO 80369-6, Annex H, describes a deviation to the physical test NON-INTERCONNECTABLE characteristics of 212

ISO 80369-1, Annex B. A rationale for the deviation is provided in Annex A. For neuraxial SMALL-BORE CONNECTORS, 213

ISO 80369-6, Annex H, supersedes ISO 80369-1 Annex B. 214

Where the design of the SMALL-BORE CONNECTORS of this standard, relies on dimensions or features of the 215

MEDICAL DEVICE or ACCESSORY to ensure NON-INTERCONNECTABLE characteristics, the MANUFACTURER shall verify 216

the NON-INTERCONNECTABLE characteristics. Check compliance by application of the tests of Annex H. When 217

necessary, the SMALL-BORE CONNECTOR may be installed on the MEDICAL DEVICE or ACCESSORY to demonstrate 218

compliance with the NON-INTERCONNECTABLE requirements of Annex H. 219

NOTE 2 MEDICAL DEVICES using the SMALL-BORE CONNECTORS of this standard that do not rely on the dimensions or features 220

of the MEDICAL DEVICE or ACCESSORY to ensure NON-INTERCONNECTABLE characteristics are presumed to comply with the NON-221

INTERCONNECTABLE characteristics test requirements of this standard by virtue of testing used to create and validate this 222

standard. 223

NOTE 3 The summary of MEDICAL DEVICES and their attributes with CONNECTIONS within this APPLICATION is provided in 224

informative Annex D. 225

NOTE 4 The summary of the usability requirements for CONNECTORS for this APPLICATION is provided in informative Annex E. 226

NOTE 5 The summary of criteria and requirements for CONNECTORS for this APPLICATION is provided in informative Annex F. 227

ISO/IEC DIS 80369-6


NOTE 6 The summary of assessment of the design of CONNECTORS for this APPLICATION according to ISO 80369-1:2010, 228

Clause 7, is contained in informative Annex G. 229

4.2 Material used for SMALL-BORE CONNECTORS 230

In addition to the requirements of ISO 80369-1:2010, Clause 4, SMALL-BORE CONNECTORS of MEDICAL DEVICES or 231

ACCESSORIES shall be made of materials with a modulus of elasticity either in flexure or in tension greater than 232

950 MPa. 233

Check compliance by application of the tests of ASTM D638 or ASTM D790. 234

4.3 Compatibility 235

4.3.1 Compatibility with substances used 236

The material from which the SMALL-BORE CONNECTOR of MEDICAL DEVICES or ACCESSORIES is made shall be 237

compatible with the substances intended to be passed through the CONNECTOR. 238

Check compliance by inspection of the RISK MANAGEMENT FILE. 239

4.3.2 Biocompatibility 240

The SMALL-BORE CONNECTOR of MEDICAL DEVICES or ACCESSORIES shall be evaluated to the requirements of 241

ISO 10933-1:2009. 242

Check compliance by application of ISO 10933:2009. 243

5 Dimensional requirements for SMALL-BORE CONNECTORS for neuraxial APPLICATIONS 244

SMALL-BORE CONNECTORS intended to be used in the neuraxial APPLICATION shall comply with the relevant 245

dimensions and tolerances as given in 246

Figure B.1 and Table B.1 for a male SLIP CONNECTOR (N1). 247

Figure B.2 and Table B.2 for a male LOCK CONNECTOR (N2). 248

Figure B.3 and Table B.3 for a male LOCK CONNECTOR with rotatable collar (N2). 249

Figure B.4 and Table B.4 for a female CONNECTOR with swept threads (N2). 250

Figure B.5 and Table B.5 for a female CONNECTOR with lugs (N2). 251

NOTE ISO 80369-1, 5.8, specifies alternative methods of compliance with the ISO 80369 (series), for SMALL-BORE 252

CONNECTORS intended for use in the neuraxial APPLICATION, which do not comply with this International Standard. 253

Check compliance by verifying the relevant dimensions and tolerances specified in Annex B. 254

The dimensions of male and female CONNECTORS made of RIGID and SEMI-RIGID MATERIALS shall comply with the 255

relevant dimensional values given in Annex B. 256

6 Performance requirements 257

6.1 General performance requirements 258

The tests described within this International Standard are TYPE TESTS. 259

ISO/IEC DIS 80369-6


6.2 Fluid leakage 260

6.2.1 Fluid leakage requirement 261

Neuraxial SMALL-BORE CONNECTORS shall either be evaluated for leakage using the leakage by pressure decay 262

TEST METHOD or be evaluated for leakage using the positive pressure liquid leakage TEST METHOD. 263

6.2.2 Leakage by pressure decay 264

Neuraxial SMALL-BORE CONNECTORS evaluated for fluid leakage performance with the leakage by pressure decay 265

TEST METHOD shall not leak by more than 0,005 Pa·m3/s while being subjected to an applied pressure of between 266

300 kPa and 330 kPa over a hold period between 15 s and 20 s using air as the medium. MANUFACTURERS may 267

use a greater applied pressure or longer hold period. 268

Check compliance by applying the tests of ISO 80369-20:—, Annex B, while using the leakage reference 269

CONNECTOR specified in Annex C. 270

6.2.3 Positive pressure liquid leakage 271

Neuraxial SMALL-BORE CONNECTORS evaluated for fluid leakage performance with the positive pressure liquid 272

leakage TEST METHOD shall show no signs of leakage, sufficient to form a falling drop of water, over a hold period 273

of 30 s to 35 s while being subjected to an applied pressure of between 300 kPa and 330 kPa. MANUFACTURERS 274

may use a greater applied pressure or a longer hold period. 275

Check compliance by applying the tests of ISO 80369-20:—, Annex C, while using the leakage reference 276


6.3 Subatmospheric-pressure air leakage 278

Neuraxial SMALL-BORE CONNECTORS evaluated for subatmospheric pressure air leakage. Neuraxial SMALL-BORE 279

CONNECTORS shall not leak by more than 0,005 Pa·m3/s while being subjected to an applied subatmospheric 280

pressure of between 80,0 kPa and 88,0 kPa over a hold period of between 15 s and 20 s. MANUFACTURERS may 281

use a greater applied subatmospheric pressure. 282

Check compliance by applying the tests of ISO 80369-20:—, Annex D, while using the stress cracking reference 283


6.4 Stress cracking 285

Neuraxial SMALL-BORE CONNECTORS evaluated for stress cracking. Neuraxial SMALL-BORE CONNECTORS shall meet 286

the requirements of 6.2.1 after being subjected to stresses of ISO 80369-20:—, Annex E. 287

Check compliance by applying the tests of ISO 80369-20:—, Annex E, while using the stress cracking reference 288


6.5 Resistance to separation from axial load 290

Neuraxial SMALL-BORE CONNECTORS shall be evaluated for separation from axial load. Neuraxial SMALL-BORE 291

CONNECTORS shall not separate from the reference CONNECTOR over a hold period between 10 s and 15 s while 292

being subjected to a disconnection applied axial force between: 293

a) 23 N and 25 N for a SLIP CONNECTOR; and 294

b) 32 N and 35 N for a LOCK CONNECTOR. 295

MANUFACTURERS may use a greater disconnection applied axial force or a longer hold period. 296

ISO/IEC DIS 80369-6


Check compliance by applying the tests of ISO 80369-20:—, Annex F, while using the separation from axial load 297

reference CONNECTOR specified in Annex C. 298

6.6 Resistance to separation from unscrewing 299

LOCK CONNECTORS shall be evaluated for separation from unscrewing. A LOCK CONNECTOR shall not separate from 300

the reference CONNECTOR for a hold period between 10 s and 15 s while being subjected to an unscrewing torque 301

of between 0,0198 N·m to 0,02 N·m. MANUFACTURERS may use a greater applied unscrewing torque or a longer 302

hold period. 303

Check compliance by applying the tests of ISO 80369-20:—, Annex G, while using the separation from axial load 304


6.7 Resistance to overriding 306

Neuraxial SMALL-BORE CONNECTORS shall be evaluated for resistance to overriding. Neuraxial SMALL-BORE 307

CONNECTORS shall not override the threads or lugs of the reference CONNECTOR while being subjected to an 308

applied torque of between 0,15 N·m to 0,17 N·m over a hold period between 5 s and 10 s. MANUFACTURERS may 309

use a greater applied torque or a longer hold period. 310

Check compliance by applying the tests of ISO 80369-20:—, Annex H, while using the separation from axial load 311


313

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Annex A 314

315

(informative) 316

317

Rationale and guidance 318

A.1 General guidance 319

This Annex provides a rationale for some requirements of ISO 80369-6, and is intended for those who are familiar 320

with the subject of ISO 80369-6 but who have not participated in its development. An understanding of the 321

rationale underlying these requirements is considered to be essential for their proper application. Furthermore, as 322

clinical practice and technology change, it is believed that a rationale will facilitate any revision of this part of 323

ISO 80369 necessitated by those developments. 324

A.2 Rationale for particular clauses and subclauses 325

The clauses and subclauses in this Annex have been numbered to correspond to the numbering of the clauses 326

and subclauses of this document to which they refer. The numbering is, therefore, not consecutive. 327

Subclause 1 – Scope 328

In 2000, a Task Group of the European standards organisation CEN proposed a strategy to reduce incidents of 329

accidental misconnection of PATIENT therapy lines by the use of a series of NON-INTERCONNECTABLE 330

CONNECTORS, differentiated by design, for use in different medical applications. The strategy reserves the use of 331

Luer CONNECTORS solely for use in MEDICAL DEVICES used to access the vascular system or for hypodermic 332

syringes so that they can achieve their intended function. [5] The CONNECTORS .of this standard are reserved for 333

neuraxial APPLICATIONS. 334

MANUFACTURERS and RESPONSIBLE ORGANIZATIONS are encouraged to report their experience with the SMALL-BORE 335

CONNECTORS specified in this part of ISO 80369 to the Secretariat of ISO TC 210, so that it can consider this 336

feedback during the revision of the relevant part of this series of International Standards. 337

Annex B 338

Dimension ‘K’ & ‘k’ are defined to ensure an understanding by MANUFACTURERS of the extent of the CONNECTOR. 339

Failure to comply with these minimum dimensions could result in the inability to properly connect to neuraxial 340

CONNECTORS produced by other MANUFACTURERS. The Figure A.1 and Figure A.2 illustrates this concern. 341

All surface finishes of parts of these CONNECTORS which do not form part of the mating surfaces should be 342

constructed so as to avoid the possibility of any another CONNECTOR, which could be present in the clinical 343

environment, from being able to form a fluid-tight CONNECTION to the CONNECTORS specified within this standard. 344

This ensures that attempts made to connect any other CONNECTOR (not complying with this part of ISO 80369) to 345

one specified within this standard results in fluid leakage and the failure to establish a fluid-tight path into the 346

CONNECTORS specified within this standard. 347

Annex B defines a maximum internal diameter of the male CONNECTOR, to prevent inadvertent male-to-male 348

connectivity between the CONNECTORS defined within this standard and any other standardised SMALL-BORE 349

CONNECTORS used in healthcare APPLICATIONS. 350

351

ISO/IEC DIS 80369-6


352

NOTE The cones form a seal properly. 353

Figure A.1 — Extent of the CONNECTOR, compliant with standard (K > 8,6 mm) 354

355

NOTE The cones do not form a seal properly. 356

Figure A.2 — Extent of the CONNECTOR, not compliant with standard (K < 8,6 mm) 357

H.1 – Purpose 358

Several deviations from the physical testing for NON-INTERCONNECTABLE characteristics TEST METHOD of 359

ISO 80369-1:2010, Annex B were developed. These include: 360

a) Axial force up to 70 N is changed to (70 ± 1) N to clarify the requirement. 361

NOTE if no axial load were applied, this would be less than 70 N and would meet the technical requirements but not the 362

intent of the standard. 363

ISO/IEC DIS 80369-6


b) Rotate up to 270° rather than 90°. CONNECTORS employ dual start threads spaced 180° apart. Rotating only 364

90° allows a false negative since this is less than 180°. 365

c) The axial separation force is changed to either 0,02 N or the weight of the CONNECTOR to allow for gravity 366

testing if desired. 367

d) Physical NON-INTERCONNECTABLE characteristics are defined as a combination of parts mechanically mating 368

but also leaking at a low-flow rate that a USER might not notice. 369

Change to disconnection at 2 g or the weight of the CONNECTOR. 370

The NON-INTERCONNECTABLE characteristics TEST METHOD described in ISO 80369-1, Annex B, poses technical 371

challenges for MANUFACTURERS to perform accurately. According to the original Annex B TEST METHOD, the 372

CONNECTORS are compressed with an axial load of 70 N and a torque of 0,12 N·m for 10 s and then are required 373

disconnect with a force no greater than 0,02 N (2 g). Many MANUFACTURERS and test houses want to use a tensile 374

tester to apply the axial load and the disconnection force with the same instrument. To apply the 70 N axial load, 375

a 100 N load cell is required to handle the 70 N applied load. A typical 100 N load cell has an accuracy of 0,1% 376

which means that a 100 N load cell is only accurate to ± 0,1 N. This is not sufficiently accurate to measure a 377

0,02 N disconnection force. Thus, the same instrument cannot measure both the applied axial load and the 378

disconnection force with the accuracy required to perform the TEST METHOD. 379

Since using one instrument to apply a 70 N load and detect a 0,02 N separation force is not practical, a gravity 380

detection method is permitted after applying the load and torque. The TEST METHOD is modified such that the 381

CONNECTORS are required to disengage with either 0,02 N or the weight of the CONNECTOR. Most neuraxial 382

components weigh more than 2 grams so the acceptance criteria must be modified to accommodate the weight of 383

the part. Table A.1 shows representative part weights of common neuraxial components. 384

Table A.1 Mass of Common Neuraxial Components6 385

Neuraxial component Mass

g

Equivalent force

N

LOR syringe (10 cc barrel only) 4,40 0,044

Spinal needle (25 gauge) and protective sheath but no stylet 1,99 0,02

Epidural tuohy needle (16 gauge) and protective sheath but no stylet 3,99 0,04

Syringe (20 ml barrel only) 6,70 0,067

Filter 0,2 micron flat in line 5,14 0,051

Catheter CONNECTOR 3,40 0,034

386

H.5 – Test procedure, leakage 387

The NON-INTERCONNECTABLE characteristics physical TEST METHOD defined in ISO 80369-1:2010, Annex B, sets 388

optimal and desirable goals, which are practically difficult to implement with all SMALL-BORE CONNECTORS. This 389

TEST METHOD utilizes a very high axial load (70 N). Anaesthesiologists are highly unlikely to apply such a large 390

force to connect two CONNECTORS when undertaking a spinal injection due to the RISK of moving the needle and 391

dislodging the tip from the intrathecal space. However, higher forces are possible when connecting MEDICAL 392

DEVICES distant from the PATIENT such as an administration set to an epidural filter. The 70 N axial load was 393

established based on what a USER could physically apply; not necessarily what a neuraxial USER would likely 394

apply in a clinical setting. [13] 395

ISO/IEC DIS 80369-6


The usability study reported in G.4 demonstrated that a 70 N axial load is excessive for this APPLICATION. The 396

average force at which USERS recognized a misconnection and stopped trying to connect was 26 N. One user did 397

exceed 70 N (86 N). This data indicates that most clinicians would recognize a misconnection well below the axial 398

load levels set by the original TEST METHOD. 399

During the same usability study, the leak rate of a misconnection was evaluated as to what leak rate the clinicians 400

would recognize that the non-mating parts were leaking. The clinicians all stated that this misconnection would 401

not cause a significant clinical RISK because the high force needed to make the CONNECTION combined with 402

profuse leaking, would provide sufficient clues of a mis-connection and they would stop the procedure. 403

USERS were asked at what leakage rate they would expect to identify a leak and stop delivering medication. The 404

average leakage rate at which clinicians would notice a leak was 6 % and the maximum leakage rate was 25 %. 405

By setting the minimum leak requirement at 75 %, more than 99,9 % of clinicians would recognize a 406

misconnection and stop administering medication. [15] To clarify, clinicians are stating that they would recognize 407

a leak if the leak was 1 % up to 25 % of the total infusate. This is not an indication that fluid passage through the 408

device is acceptable. This study was modelled after misconnection testing conducted by Cook. [7] This study 409

analysed anaesthesiologists reaction to new non-Luer neuraxial MEDICAL DEVICES. Of the various misconnections 410

noted in the report, the clinicians discounted the misconnections that leaked significantly. The clinicians stated 411

that between the high force to connect and profuse leaking, the CONNECTION was not a clinical RISK. 412

A second experiment was conducted to evaluate if a low flow infusion pump with a flow rate of 4 ml/h could pump 413

medication through a misconnection and not be noticed by a clinician. Eight 20 gauge epidural catheters and 414

catheter CONNECTORS were misconnected with a male N2 CONNECTOR, to female L1, as described in 415

ISO 80369-7:—. A low flow infusion pump provided a steady, low flow rate of 4 ml/hr. The misconnected joint did 416

not allow any pressure to be generated upstream of the catheter and no fluid was pumped into the catheter; 417

100 % of low flow fluid leaked from the misconnection. Therefore, even if a misconnection is made and a gross 418

leak is not detected by the clinician, fluid is not erroneously delivered to the PATIENT. 419

ISO/IEC DIS 80369-6


Annex B 421

422

(normative) 423

424

* SMALL-BORE CONNECTORS for neuraxial APPLICATIONS 425

426

Table B.1 contains the dimensions for this figure. 427

Figure B.1 — Male neuraxial SLIP CONNECTOR (N1) 428

ISO/IEC DIS 80369-6


Table B.1 — Male neuraxial SLIP CONNECTOR dimensions (N1) 429

Dimensions in mm unless otherwise indicated 430

Male neuraxial SLIP CONNECTOR (N1)

Reference Designation Dimension

Minimum Nominal Maximum

(a) Angle of the taper (5 % taper nominal) (degrees, reference)

(2,58°) (2,86°) (3,15°)

c Recess or protrusion of the tip of the CONNECTOR from the collar a -0.200 0.000 0.400

Ød Outside diameter at the tip of the male taper at 0,500 (basic dimension) from the tip (small end) of the male taper

3,185 3,210 3,235

e Length of the male taper b 8,130 8,380 8,630

Øf Inside diameter at the tip of the male taper — 1,150— 2,300

Øg Outside diameter of the larger end of the male taper at 6,500 (basic dimension) from the tip (small end) of the male taper

3,450 3,510 3,570

Øh Inside collar diameter 6,750 6,925 7,100

k Length of CONNECTOR from tip of the male taper c 8,000 8,300 —

r1 Radius or chamfer at the outside tip of the male taper

0,000 0,100 0,200

r2 Radius or chamfer at the tip of the male outside diameter of minimum tangential circle of the male collar (dimension Øw)

0,000 0,100 0,200

r3 Radius or chamfer at the inside tip of the male lumen

0,000 0,100 0,200

r4 Radius or chamfer at the inside tip of the male collar

0,000 0,100 0,200

Øu Inside diameter of the fluid lumen of the CONNECTOR (optional)

— 1,150 2,300

Øw Diameter of the smallest cylinder of depth k that encompasses the outside surfaces of the external features of the collar d

8,850 10,575 12,300

a The minimum dimension indicated defines the recess of the tip of the CONNECTOR from the collar and the maximum dimension defines the protrusion of the tip of the CONNECTOR from the collar.

b This dimension also defines the internal extent of the CONNECTOR. MEDICAL DEVICE features beyond the CONNECTOR may require evaluation to ISO 80369-1:2010, Annex B, to ensure NON-INTERCONNECTABLE characteristics.

c This dimension also defines the external extent of the CONNECTOR. MEDICAL DEVICE features beyond the CONNECTOR may require evaluation to ISO 80369-1:2010, Annex B, to ensure NON-INTERCONNECTABLE characteristics.

d Either the CONNECTOR or the MEDICAL DEVICE that incorporates this CONNECTOR may achieve this dimension. Alternatively, NON-INTERCONNECTABLE characteristics may be demonstrated using ISO 80369‐1:2010, Annex B.

431

ISO/IEC DIS 80369-6


432


Figure B.2 — Male neuraxial LOCK CONNECTOR (N2) 434

ISO/IEC DIS 80369-6


Table B.2 — Male neuraxial LOCK CONNECTOR dimensions (N2) 435


Male neuraxial LOCK CONNECTOR (N2)



b Angle of the internal thread profile on the nonbearing surface against separation (degrees, reference)

(11,25°) (13,75°) (16,25°)

Øj Minor inside thread diameter (diameter at the thread crest)

5,420 5,520 5,620

(m) Width of the thread profile at the crest (reference) — (0,651) —

n Width of the thread profile at the root 0,890 0,995 1,100

p Pitch of the double‐start, right‐hand thread (reference 5 mm lead)

2,400 2,500 2,600

r5 Radius or chamfer on male thread — 0,090 0,100

s Angle of the internal thread profile on the bearing surface against separation (degrees)

11,25° 13,75° 16,25°

t Distance from the tip of the CONNECTOR to the start at the root of the first complete thread profile of the internal thread

— 1,500 1,800

The design and dimensions of the thread profile (s, b and m) may vary from those designated providing the CONNECTOR meets the performance requirements of Clause 6.

Thread revolution length is not specified, but shall provide clearance for the thread of the female CONNECTOR.

The male neuraxial LOCK CONNECTOR shall include the dimensions and tolerances of the male neuraxial SLIP CONNECTOR as specified in Figure B.1 and Table B.1.

437

ISO/IEC DIS 80369-6


438


Figure B.3 — Male neuraxial LOCK CONNECTOR with rotatable collar (N2) 440

ISO/IEC DIS 80369-6


Table B.3 — Male neuraxial LOCK CONNECTOR with rotatable collar dimensions (N2) 441


Male neuraxial LOCK CONNECTOR with rotatable collar (N2)



c c Recess of the tip of the CONNECTOR from the collar -0,200 0,000 0,400

e Length of the male taper 8,130 8,380 8,630

k d Length of CONNECTOR from tip of the male taper b 8,000 8,300 —

t d Distance from the tip of the CONNECTOR to the start at the root of the first complete thread profile of the internal thread

— 1,500 1,800

The male neuraxial LOCK CONNECTOR shall include the dimensions and tolerances of the male neuraxial CONNECTOR as specified in Figures B.1 and B.2 and Tables B.1 and B.2.

a This dimension also defines the internal extent of the CONNECTOR. MEDICAL DEVICE features beyond the CONNECTOR may require evaluation Annex H, to ensure NON-INTERCONNECTABLE characteristics.

b This dimension also defines the external extent of the CONNECTOR. MEDICAL DEVICE features beyond the CONNECTOR may require evaluation Annex H, to ensure NON-INTERCONNECTABLE characteristics.

c This dimension is when the rotatable collar is positioned fully away from tip of the CONNECTOR. The minimum dimension indicated defines the recess of the tip of the CONNECTOR from the collar and the maximum dimension defines the protrusion of the tip of the CONNECTOR from the collar.

d This dimension is when the rotatable collar is positioned fully toward the tip of the CONNECTOR.

443

ISO/IEC DIS 80369-6


444


Figure B.4 — Female neuraxial LOCK CONNECTOR (N2) 446

ISO/IEC DIS 80369-6


Table B.4 — Female neuraxial LOCK CONNECTOR dimensions (N2) 447


Female neuraxial LOCK CONNECTOR (N2)



(A) Angle of the taper (5 % taper nominal) (degrees, reference)

— (2,86°) —

B Angle of the internal thread profile on the nonbearing surface against separation (degrees)

11,25° 13,75° 16,25°

ØD Inside diameter at the open end of the female taper at 0,500 (basic dimension) from the opening (large end) of the female taper

3,405 3,430 3,455

E Depth of the female taper a 8,200 8,450 8,700

ØG Inside diameter of the smaller end of the female taper at 6,500 (basic dimension) from the opening (large end) of the female taper

3,070 3,130 3,190

ØH

Major outside thread diameter (diameter at the thread crest) for the extent of the thread feature. This defines the diameter of the smallest cylinder of depth K that encompasses the outside surfaces of the external features of the CONNECTOR.

6,120 6,220 6,320

ØJ Minor outside thread diameter (diameter at the thread root)

5,000 5,185 5,370

K Length of the CONNECTOR b 8,600 8,900 —

(M) Width of the thread profile at the crest (reference) — (0,787) —

N Width of the thread profile at the root at a diameter corresponding to ØJ maximum (5,370)

0,890 0,995 1,100

P Pitch of the double‐start, right‐hand thread (reference 5 mm lead)

2,400 2,500 2,600

R1 Radius or chamfer at the entrance of the female taper

0,000 0,100 0,200

R2 Radius or chamfer on the female thread 0,000 0,090 0,100

S Angle of the internal thread profile on the bearing surface against separation (degrees)

11,25° 13,75° 16,25°

ØU Inside diameter of the fluid lumen of the CONNECTOR (optional)

— 1,500 2,300

The design and dimensions of the thread profile (s, b and m) may vary from those designated providing the CONNECTOR meets the performance requirements of Clause 6.

a This dimension also defines the internal extent of the CONNECTOR. MEDICAL DEVICE features beyond the CONNECTOR may require evaluation to Annex H to ensure NON-INTERCONNECTABLE characteristics.

b This dimension also defines the external extent of the CONNECTOR. MEDICAL DEVICE features beyond the CONNECTOR may require evaluation to Annex H to ensure NON-INTERCONNECTABLE characteristics.

449

ISO/IEC DIS 80369-6


450


Figure B.5 — Female neuraxial LOCK CONNECTOR with lugs (N2) 452

ISO/IEC DIS 80369-6


Table B.5 — Female neuraxial LOCK CONNECTOR with lugs dimensions (N2) 453


Female neuraxial SLIP CONNECTOR with lugs (N2)



(A) Angle of the taper (5 % taper nominal) (degrees, reference)

— (2,86°) —

ØD Inside diameter at the open end of the female taper at 0,500 (basic dimension) from the opening (large end) of the female taper

3,405 3,430 3,455

E Depth of the female taper a 8,200 8,450 8,700

ØG Inside diameter of the smaller end of the female taper at 6,500 (basic dimension) from the opening (large end) of the female taper

3,070 3,130 3,190

ØH

Major outside lug diameter (diameter at the lug crest) for the extent of the lug feature. This defines the diameter of the smallest cylinder of depth K that encompasses the outside surfaces of the external features of the CONNECTOR.

6,120 6,220 6,320

ØJ Minor outside lug diameter (diameter at the lug root)

5,000 5,185 5,370

K Length of the CONNECTOR b 8,600 8,900 —

M Width of the lug profile at the crest 0,400 0,500 0,600

N Width of the lug profile at the root at a diameter corresponding to ØJ maximum (5,370)

0,700 0,900 1,100

R1 Radius or chamfer at the entrance of the female taper

0,000 0,100 0,200

R2 Radius or chamfer on the female lug 0,000 0,090 0,100

ØU Inside diameter of the fluid lumen of the CONNECTOR (optional)

— 1,500 2,300

V Angle of the slope of the lug to be measured from a plane parallel with the tip of the CONNECTOR (degrees)

11,0° 13,0° 15,0°

Y

Chord length at the base of the lug in a plane at a right angle to the axis of the CONNECTOR, to be measured on a chord of a circle, the diameter of which is 5,370

4,100 4,250 4,400

The design and dimensions of the lug profile (M and V) may vary from those designated providing the CONNECTOR meets the performance requirements of Clause 6.

a This dimension also defines the internal extent of the CONNECTOR. MEDICAL DEVICE features beyond the CONNECTOR may require evaluation to Annex H to ensure NON-INTERCONNECTABLE characteristics.

b This dimension also defines the external extent of the CONNECTOR. MEDICAL DEVICE features beyond the CONNECTOR may require evaluation to Annex H to ensure NON-INTERCONNECTABLE characteristics.

455

456

DRAFT INTERNATIONAL STANDARD ISO/IEC DIS 80369-6


Annex C 457

458

(normative) 459

460

Reference CONNECTORS for testing SMALL-BORE CONNECTORS 461

for neuraxial APPLICATIONS 462

C.1 General requirements for reference CONNECTORS 463

The reference CONNECTORS shall be manufactured from corrosion-resistant RIGID MATERIALS with a surface 464

roughness value, Ra, not exceeding 0,8 μm on critical surfaces. 465

The dimensions of these reference CONNECTORS shall be in accordance with those specified in Figure C.1 and 466

Table C.1 or Table C.2, as appropriate. 467

468

469

470

471

472

473

474

475

476

477

478

479

480

481

482

483

ISO/IEC DIS 80369-6


C.2 Reference CONNECTORS 484

485

NOTES: 486 1. THREAD IS TWO START 487 2. REFERENCE CONNECTOR IS TO BE USED WITH TEST: 488

FLUID LEAKAGE BY PRESSURE DECAY 489 FALLING DROP POSITIVE PRESSURE LIQUID LEAKAGE 490 SUB ATMOSPHERIC PRESSURE AIR LEAKAGE 491 STRESS CRACKING 492 RESISTANCE TO SEPARATION FROM UNSCREWING 493

3. SEALING CONE SURFACE FINISH TO BE 0.4µm Ra OR FINER (ROUGHNESS AVERAGE) PER VISUAL COMPARISON TO 494 SURFACE FINISH STANDARDS, OR EQUIVALENT GAUGING METHOD. 495

4. THREAD FLANK SURFACE FINISH TO BE 0.8µm Ra OR FINER (ROUGHNESS AVERAGE) PER VISUAL COMPARISON TO 496 SURFACE FINISH STANDARDS, OR EQUIVALENT GAUGING METHOD 497

5. COMPLIANCE OF ALL LISTED DIMENSIONS ARE REQUIRED FOR INITIAL CALIBRATION 498 6. MINIMUM COMPLIANCE VERIFICATIONS FOR SUBSEQUENT CALIBRATION 499 7. (REFERENCE: THREADS TO COMPLETE ONE FULL REVOLUTION) 500 8. RELIEF CUT 0.200 MAXIMUM DEPTH 501 9. MASTER GAGES CAN BE USED FOR CALIBRATION VERIFICATIONS (TAPER GAGE EXAMPLE SHOWN BELOW) 502

1. APPLY A THIN FILM OF BLUEING TO GAUGING SURFACE 503 2. INSERT GAGE INTO TESTING CONNECTOR 504 3. APPLY 2N +/-0.25N FORCE TO MASTER GAGE 505 4. APPLY 90 DEGREE +/-45 DEGREE TURN TO MASTER GAGE 506 5. BLUEING MASTER GAGE METHODS ARE TO ACHIEVE 75% MINIMUM BLUEING CONTACT OF THE TESTED 507

CONNECTOR TO SHOW CONNECTOR ACCEPTABILITY 508

509

Figure C.1 — Female reference LOCK CONNECTOR for testing male neuraxial CONNECTORS for leakage, 510

separation from unscrewing, stress cracking and NON-INTERCONNECTABLE characteristics 511

512

ISO/IEC DIS 80369-6


513

NOTES: 514 1. REFERENCE CONNECTOR IS TO BE USED WITH TEST: 515

FLUID LEAKAGE BY PRESSURE DECAY 516 FALLING DROP POSITIVE PRESSURE LIQUID LEAKAGE 517 SUB ATMOSPHERIC PRESSURE AIR LEAKAGE 518 STRESS CRACKING 519 RESISTANCE TO SEPARATION FROM AXIAL LOAD 520


3. COMPLIANCE OF ALL LISTED DIMENSIONS ARE REQUIRED FOR INITIAL CALIBRATION 523 4. MINIMUM COMPLIANCE VERIFICATIONS FOR SUBSEQUENT CALIBRATION 524 5. GO/NO-GO GAGES CAN BE USED FOR CALIBRATION VERIFICATIONS, WHERE APPLICABLE 525 6. MASTER GAGES CAN BE USED FOR CALIBRATION VERIFICATIONS (TAPER GAGE EXAMPLE SHOWN BELOW) 526



533

Figure C.2 — Male reference SLIP CONNECTOR for testing female neuraxial CONNECTORS for leakage, 534


ISO/IEC DIS 80369-6


536

NOTES: 537 1. REFERENCE CONNECTOR IS TO BE USED WITH TEST: 538

RESISTANCE TO SEPARATION FROM AXIAL LOAD 539 RESISTANCE TO OVER-RIDING 540


3. LUG FLANK SURFACE FINISH TO BE 0.8µm Ra OR FINER (ROUGHNESS AVERAGE) PER VISUAL COMPARISON TO SURFACE 543 FINISH STANDARDS, OR EQUIVALENT GAUGING METHOD 544

4. COMPLIANCE OF ALL LISTED DIMENSIONS ARE REQUIRED FOR INITIAL CALIBRATION 545 5. MINIMUM COMPLIANCE VERIFICATIONS FOR SUBSEQUENT CALIBRATION 546 6. MASTER GAGES CAN BE USED FOR CALIBRATION VERIFICATIONS (TAPER GAGE EXAMPLE SHOWN BELOW) 547



554

Figure C.3 — Female reference CONNECTOR for testing male neuraxial CONNECTORS for separation from 555

axial load and resistance to overriding 556

ISO/IEC DIS 80369-6


557

NOTES: 558 1. THREAD IS TWO START 559 2. REFERENCE CONNECTOR IS TO BE USED WITH TEST: 560

FLUID LEAKAGE BY PRESSURE DECAY 561 FALLING DROP POSITIVE PRESSURE LIQUID LEAKAGE 562 SUB ATMOSPHERIC PRESSURE AIR LEAKAGE 563 STRESS CRACKING 564 RESISTANCE TO SEPARATION FROM REVERSAL TORQUE 565



5. COMPLIANCE OF ALL LISTED DIMENSIONS ARE REQUIRED FOR INITIAL CALIBRATION 570 6. MINIMUM COMPLIANCE VERIFICATIONS FOR SUBSEQUENT CALIBRATION 571 7. MEASURE TO FLAT FACE ON THREAD AT JUNCTURE OF THREAD MAJOR DIAMETER AND THREAD 572 8. CIRCUMFERENCIAL WITNESS LINE ACCEPTABLE FROM MACHINING MUST MAINTAIN DIMENSIONAL REQUIREMENTS 573 9. GO/NO-GO GAGES CAN BE USED FOR CALIBRATION VERIFICATIONS, WHERE APPLICABLE 574 10. MASTER GAGES CAN BE USED FOR CALIBRATION VERIFICATIONS (TAPER GAGE EXAMPLE SHOWN BELOW) 575



582

Figure C.4 — Male reference LOCK CONNECTOR for testing female neuraxial CONNECTORS for leakage, 583


ISO/IEC DIS 80369-6


585

NOTES: 586 1. THREAD IS TWO START 587 2. REFERENCE CONNECTOR IS TO BE USED WITH TEST 588

RESISTANCE TO SEPARATION FROM AXIAL LOAD 589 RESISTANCE TO OVER-RIDING 590



5. COMPLIANCE OF ALL LISTED DIMENSIONS ARE REQUIRED FOR INITIAL CALIBRATION 595 6. MINIMUM COMPLIANCE VERIFICATIONS FOR SUBSEQUENT CALIBRATION 596 7. MEASURE TO FLAT FACE ON THREAD AT JUNCTURE OF THREAD MAJOR DIAMETER AND THREAD 597 8. CIRCUMFERENCIAL WITNESS LINE ACCEPTABLE FROM MACHINING MUST MAINTAIN DIMENSIONAL REQUIREMENTS 598 9. GO/NO-GO GAGES CAN BE USED FOR CALIBRATION VERIFICATIONS, WHERE APPLICABLE 599 10. MASTER GAGES CAN BE USED FOR CALIBRATION VERIFICATIONS (TAPER GAGE EXAMPLE SHOWN BELOW) 600



607

Figure C.5 — Male reference CONNECTOR for testing female neuraxial LOCK CONNECTORS from axial load and 608

resistance to overriding 609

610

611

ISO/IEC DIS 80369-6


Annex D 612

613

(informative) 614

615

Assessment of MEDICAL DEVICES and their attributes 616

with CONNECTIONS within this APPLICATION 617

Table D1 contains examples of MEDICAL DEVICES and ACCESSORIES with neuraxial APPLICATIONS. The table 618

contains an assessment by the working group of the important attributes of MEDICAL DEVICES and ACCESSORIES as 619

they relate to the intended CONNECTION. Each CONNECTION is assessed to the following groups of subgroups: 620

a) Spinal needle CONNECTIONS 621

b) Epidural needle CONNECTIONS 622

c) Regional block needle CONNECTIONS including stimulating needles 623

d) Neuraxial catheter CONNECTORS 624

e) Bacterial filter CONNECTORS 625

f) Infusion line CONNECTORS 626

g) Neuraxial ACCESSORIES such as stopcocks, manometers, drug draw up devices, extension set 627

h) Wound infiltration devices with neuraxial CONNECTORS 628

i) Neuraxial syringe CONNECTORS including loss of resistance (LOR) 629

j) Intrathecal catheters 630

631

ISO/IEC DIS 80369-6


Table D.1 — Examples of MEDICAL DEVICES with CONNECTIONS 632

within this APPLICATION and their attributes 633

Part/component to which the CONNECTOR is applied In

dex

Flow administration

Type of fluid

Type of CONNECTION

Functionality

Flo

wra

te r

ang

e

ml/m

in

Bo

lus

Air

Liq

uid

CO

NN

EC

TIO

N

Dis

- CO

NN

EC

TIO

N

Lo

ckin

g n

eed

ed

Sli

p n

ee

de

d

Flo

wra

te c

on

tro

l n

eed

ed

Spinal needle (bolus) 1 0 to

3 600 yes yes yes yes yes yes no yes

Epidural/regional block needle (bolus)

2 0 to

3 600 yes yes yes yes yes yes no Yes

Catheter CONNECTOR (bolus) 3 0 to

1 500 yes no yes yes yes yes no yes

Catheter CONNECTOR (infusion)

4 0 to


Filter (infusion) 5 0 to 600

yes no yes yes yes yes no yes

Filter (bolus) 6 0 to 600


Infusion line 7 0 to 600


Wound infiltration 8 0 to


Syringe standard 9 0 to

3 600 yes yes yes yes yes yes yes yes

Syringe, loss of resistance (LOR)

10 0 to

3 600 no yes yes yes yes yes yes yes

634

635

ISO/IEC DIS 80369-6


Annex E 636

637

(informative) 638

639

Summary of the usability requirements 640

for SMALL-BORE CONNECTORS for neuraxial APPLICATIONS 641

E.1 USER PROFILE 642

The USER PROFILE is a summary of the mental, physical and demographic traits of an intended USER population as 643

well as any special characteristics that can have a bearing on design decisions such as occupational skills and 644

job requirements. 645

USERS of SMALL-BORE CONNECTORS for neuraxial APPLICATIONS are comprised of clinical persons using (i.e. 646

operating or handling) the MEDICAL DEVICE, including but not limited to cleaners, maintainers and installers. USERS 647

are expected to perform an intended action in an intended use of a MEDICAL DEVICE, ACCESSORY, PROCESS or 648

service in accordance with the specifications, instructions and information provided by the MANUFACTURER. 649

USERS include: 650

a) Clinical users as: 651

Physicians and nurses (CRNA’s) who specialize in anaesthesiology, neuro-radiology, oncology, 652

interventional radiology, paediatrics, surgery or a physician assistant 653

Nurses, at all levels; 654

b) Non-clinical users such as cleaners, maintainers and installers; and 655

c) Pharmacy or drug delivery USERS responsible for mixing of drugs, filling syringes and reservoirs, storage and 656

dispensing of drugs. 657

The USER PROFILE is summarized in Table E.1 658

Table E.1 — USER PROFILE 659

Clinical USERS Non-clinical USERS Pharmacy/drug delivery USERS

USER skills: Extensive clinical training

Limited clinical training

Pharmacology

PATIENT contact: Direct PATIENT contact Direct PATIENT contact No PATIENT contact

660

E.2 Use scenarios 661

Use scenarios for SMALL-BORE CONNECTORS for neuraxial APPLICATIONS can differ by USER group and are 662

comprised of the multitude of sub-APPLICATIONS of the CONNECTORS within different sub-specialties. 663

ISO/IEC DIS 80369-6


A summary of use scenarios by USER group is summarized in Table E.2. 664

Table E.2 — Use scenarios 665

Sub-specialty use scenario: Clinical USERS Non-clinical USERS Pharmacy USERS

Spinal diagnostics such as CSF pressure using a manometer column

X

Spinal anaesthetic delivery into the intrathecal space

X X

Intrathecal chemotherapy injection X X

Lumbar epidural bolus injection of anaesthetic agent

X X

Lumbar epidural injection of continuous anaesthetic agent via infusion pump

X X

Peripheral nerve block needle placement and bolus injection of anaesthetic agent

X X

Peripheral nerve block needle placement and continuous injection of anaesthetic agent

X X

Home care PATIENT controlled activation doses from infusion pump

X X

Hospital based PATIENT controlled activation doses from infusion pump

X X X

666

E.3 Use environments 667

E.3.1 Facilities 668

Hospitals, surgery suites, PATIENT rooms, home, labour and delivery, intensive care units doctors’ offices, pain 669

clinics, pharmacy, field hospitals, transport systems, infusion clinics, assisted care, emergency medical services 670

E.3.2 Use temperatures 671

The following temperature environments are expected for neuraxial CONNECTORS: 672

a) Ambient temperature, 0˚C to + 40 ˚C 673

b) Body temperature to 42 ˚C; 674

E.4 Other attributes 675

The following usability attributes are expected for neuraxial CONNECTORS: 676

a) Usability under stress (ignoring labels, attempting force-fit, emergency C-section); 677

b) Limited dexterity: Gloved hands that might or might not be wet. 678

c) Proximity of other CONNECTOR-bearing equipment (e.g. intravenous infusion lines, gas measurement, etc.) 679

ISO/IEC DIS 80369-6


d) Duration, use-life: 680

Maximum length of epidural infusion ≤ 29 d (includes catheter, catheter CONNECTOR and infusion line) 681

Filters, ≤ 96 h 682

Spinal or epidural needs ≤ 15 min 683

Draw up MEDICAL DEVICES such as filter needles, filter straws etc.; ≤ 15 min 684

Loss of resistance syringes; ≤ 15 min 685

Syringes for short term use; ≤ 15 min 686

Syringes and caps for drug storage ≤ 14 d 687

E.5 Generic USER needs 688

The following USER needs are expected for neuraxial CONNECTORS: 689

a) Minimal pan-healthcare USER training on the use of CONNECTORS; 690

b) Easy to manipulate without the use of tools 691

c) Ease of assembly/disassembly with fingertip control, especially in wet environment or with the use of gloves 692

d) Does not misconnect to other SMALL-BORE CONNECTORS not intended for the same purpose in the environment 693

of use 694

e) Does not leak under NORMAL USE; 695

f) Security/integrity of CONNECTION—cannot unintentionally self-disconnect; 696

g) Low dead space; 697

h) Ease of fluid passage 698

Maximum flowrate 3 600 ml/h 699

Pressure in infusion line at maximum flowrate must not exceed alarm limit on infusion pumps 700

i) Viscosity of solution 701

aqueous 702

chemotherapy 703

Anaesthetics (Bupivacaine, lidocaine, ropivacaine, 2-chloroprocaine, levobupivacaine) 704

Analgesics (Sufentanil) 705

Narcotics (morphine) 706

j) Ability to accommodate catheters through bore of neuraxial CONNECTOR 707

Catheters as large as 16 gauge 708

ISO/IEC DIS 80369-6


Ability to accommodate stylets (epidural / spinal) and/or guidewires 709

k) Aseptic handling – ability to align and make CONNECTIONS without slipping and inadvertently creating touch 710

contaminations 711

712

ISO/IEC DIS 80369-6


Annex F 713

714

(informative) 715

716

Summary of SMALL-BORE CONNECTOR criteria and requirements for neuraxial 717

APPLICATIONS 718

Table F.1 is a summary of the design criteria and requirements for the SMALL-BORE CONNECTOR for neuraxial 719

APPLICATIONS. 720

Table F.1 — Neuraxial CONNECTOR - specific criteria and requirements (1 of 2) 721

Criteria Requirements Remarks

1 Fluid type a) liquid b) gas c) both

c)

2 Operating pressure range maximum pressure minimum pressure sub-atmospheric? (Yes/No)

330 kPa N/A Yes: 40 kPa

3 RATED pressure range minimum maximum

N/A

4 Is there a need for a leak test? a) no b) yes Reference for test method

b) Yes

5 RATED flowrate range minimum maximum

N/A

10 ml/min

6 Internal tubing diameter range (through bore) minimum maximum

2,3 mm

7 RATED temperature range minimum maximum

0º C 40º C

8

Minimum range of CONNECTOR mating diameters minimum maximum

– Incompatible with Luer and/ or other new SMALL-BORE MEDICAL CONNECTORS

9

General layout a) Parallel-sided, O-ring seal b) Parallel-sided, other seal c) Conical d) Other (specify)

c) Conical, with a male tip smaller diameter than a Luer

10 Method of keying a) Collar b) Plug c) Other (specify)

N/A

11

Quick release? a) No b) Yes i) single-handed operation ii) double-handed operation

a)

12 Positive locking/unlocking feature? a) No b) Yes

a) and b)

13 Need for visual indication of a) No locking status? b) Yes

a)

14 Need for indication of evidence a) No of tampering? b) Yes

a) Depends on specific MEDICAL DEVICE

15 Need for a syringe in the a) No APPLICATION? b) Yes

b)

16 Need for an absence of sharp a) No edges? b) Yes

b)

ISO/IEC DIS 80369-6


Table D.1 — (2 of 2) 722

Criteria Requirements Remarks

17 Minimum pull-apart force in normal use, when locked force Reference for test method

35 N Same as Luer

18

Constructional materials a) RIGID MATERIAL (excluding seals) i) metal ii) plastic b) SEMI-RIGID MATERIAL

a) i) ii) b)

19 Need for use of SEMI-RIGID MATERIAL? a) No b) Yes, mating part of CONNECTOR

(apart from seal)

Yes

20

MRI compatibility? a) No, with labelling b) No, without labelling c) Yes, with labelling d) Yes, without labelling

d)

21 Stress-cracking resistance? a) No b) Yes Specify limits

b)

22 Externally, how is CONNECTOR to be distinguishable from Luer? (describe)

23 Proposal for colour-coding? a) No b) Yes Reference standard

a)

24 Labelling/Symbols/Marking? a) No (e.g. not for IV) b) Yes

a)

25 Other method for indicating a) No intended use? b) Yes Indicate method

a)

26 Biocompatibility needed? a) No b) Yes i) indicate tissue types

b) skin and spinal fluid contact

27

Reuse variants a) Multiple PATIENT use b) Single PATIENT use c) Single use d) Non-reusable (indicate method of auto-disabling)

c)

28

Decontamination needed? a) No, single use only b) Yes, cleaning and disinfection indicate method c) Yes, cleaning and sterilization indicate method

a)

29 How is ISO 80369-2 incompatibility a) Dimensional achieved? b) Other Indicate method

b)


a)


not yet defined


a)


This is the neuraxial CONNECTOR


b) Combined CAD analysis and physical testing (Annex H)

723

ISO/IEC DIS 80369-6


Annex G 724

725

(informative) 726

727

Summary of assessment of the design 728

of the SMALL BORE CONNECTORS for neuraxial APPLICATIONS 729

G.1 General 730

There are no known patents related to the CONNECTOR designs specified in this standard. The CONNECTORS 731

depicted in Annex B use a 6 % taper seal, with mating surface dimensions smaller than the traditional Luer 732

CONNECTOR This design also incorporates other features to prevent these CONNECTORS from either forming a fluid 733

tight seal or being misconnected with SMALL-BORE CONNECTORS of the ISO 80369 series. 734

G.2 Summary of the engineering analysis of the design 735

A three dimensional computer assisted (CAD) engineering analysis has been completed using 3D solid model 736

constructs of all tolerances and material conditions (least, nominal and maximum) for all SMALL-BORE CONNECTORS 737

represented by this series of International Standards. The SMALL-BORE CONNECTORS specified in Annex B have 738

been evaluated by engineering analysis with a threshold interference of 0,4 mm with the other specified 739

CONNECTORS of this series. Five possible misconnections were identified. All other CONNECTIONS have 740

interferences exceeding 0,4 mm. The five possible misconnections are shown in Table G.1 741

Misconnection number three poses no clinical RISK of wrong route administration of fluid since the misconnection 742

results in fluid pumped into a sphygmomanometer cuff. The other potential misconnections were evaluated with 743

physical testing. NON-INTERCONNECTABLE characteristics testing was conducted according to ISO 80369-1:2010, 744

Annex B (test CONNECTORS need to disconnect from a stainless steel reference CONNECTOR after 70 N axial 745

applied compressive load with 0.12 N·m torque). An injection mould was made to make test N2 CONNECTORS to 746

least material conditions (LMC) or nominal dimensions if LMC N2 CONNECTORS were not possible. (N2 747

CONNECTORS at LMC conditions were moulded from polycarbonate (Makralon RX1805 and two grades of 748

polypropylene (Total 3620WZ with flexural modulus 1665 MPa and Total Polypropylene 7238 with tensile 749

modulus of 965 MPa). N2 CONNECTORS at nominal dimensions were moulded from acrylic (Cyrolite G20). N2 750

CONNECTORS were measured and met dimensional specifications specified Annex B except for some radii, which 751

were out of specification and one exception on the threads. The Total PP 7238 threads were slightly undersized 752

(dimension “n” measured 0,83 mm vs. specified range of 0,890 mm to 1.1 mm). Thus, these samples were worst 753

case since they were smaller than the tolerance limit and were made with the most flexible material. Radii not 754

meeting specification are acceptable for evaluating NON-INTERCONNECTABLE characteristics. Radii are limited to 755

prevent misconnection so having radii that are larger challenges the worst case of the design. Stainless steel 756

reference CONNECTORS were machined to nominal dimensions as specified by ISO 80369-1, Annex B. 757

The first two misconnections passed mechanical NON-INTERCONNECTABLE characteristics testing according to 758

Annex H. The third misconnection was not tested since the RISK ANALYSIS indicates virtually no RISK to PATIENTS 759

except possible delay of therapy if fluid is pumped into a sphygmomanometer cuff. The fourth and fifth 760

misconnections interconnect when subjected to the physical mechanical test from Annex H. However, a fluid tight 761

seal is not made following the physical mechanical test. Both misconnections leaked profusely (99.8% and 87.6%, 762

which exceeds minimum required leak rate of 75%). 763

NOTE Annex H rationale contains addition information about the leak test. 764

Clinicians have confirmed that the RISK is acceptable for misconnections where the CONNECTION requires an 765

abnormally high force and the CONNECTION leaks profusely (> 75 % of injectate leaks from the misconnection). 766

The CONNECTION forces for the two misconnections were high. 767

ISO/IEC DIS 80369-6


Table G.1 — Identified possible misconnections 768

Misconnection number

1 2 3 4 5

Visual representation

Neuraxial CONNECTOR

and condition

N2 male LMC

N2 male LMC

N2 male LMC

N2 male LMC

N2 female LMC

Reference CONNECTOR

and condition

L2 male of ISO 80369-7

(nominal)

E1 male of ISO 80369-3

(nominal)

S1 male of ISO 80369-5

(nominal)

L1 female of ISO 80369-7

(nominal)

E1 female of ISO 80369-3

(nominal)

Failure mode

Medication from Luer to N2 syringe,

then transferred to

PATIENT

Medication intended to

be administered

to the neuraxial space is

administered enterally

Anaesthetic pumped into

pressure cuff, no PATIENT

HARM

Anaesthetic pumped into vascular port

Enteral feeding substances

administered to neuraxial space

Material used

Acrylic (nom), Total PP 3620WZ (LMC)

Polycarbonate (LMC)

Not tested, acceptable clinical RISK

Total PP 7238 (950 MPa.)

LMC Thread

Total PP 7238 (950 MPa)

LMC Thread

Sample Size 40 22 Not tested 30 30

Do CONNECTORS misconnect? (PASS = no CONNECTION)

40 of 40 PASS 22 of 22 PASS

Not tested 14 of 30 PASS 0 of 30 PASS

Gross leak > 75%? N/A N/A Not tested 99,8 % ± 0,46%a 87,6% ± 2,2%a

LMC = least material condition a >99 % confidence of 99 % reliability exceeding 75 % minimum

769

A RISK ANALYSIS was conducted on the total fluid that could be delivered via this CONNECTION. Misconnection five 770

could conceivably administer 13 % of its dose to a PATIENT. The team analysed the likelihood of this event 771

actually happening. 772

G.4 describes a formative usability study which was conducted in April 2014. Clinicians used syringes with 773

embedded force gauges to measure the forces at which they would stop trying to force a misconnection. 774

Figure G.1 shows a distribution of forces at which USERS would recognize a misconnection and stop. 96% of 775

clinicians would not exceed 50 N force before stopping. The misconnection force testing of N.1 female 776

CONNECTOR to E1 female reference CONNECTOR, as specified in ISO 80369-3:—, (Figure G.1, misconnection 5) is 777

shown in Figure G.2. These CONNECTORS required an average force of 55,7 N to insert into the reference 778

CONNECTOR. 99,8 % of CONNECTION forces exceed 50 N. The overlap of these two populations is the percentage 779

of USERS who would exceed the minimum force required to make a misconnection. From Figure G.1, 4 % of 780

ISO/IEC DIS 80369-6


USERS would exceed 50 N force before they recognize a misconnection and stopped administering medication. 781

Most would stop at a force well below 50 N. Figure G.2 shows that 0.8 % of CONNECTIONS require a force less 782

than 50 N to connect. The overlap of the two populations is 4 % x 0,8 % = 0,03%. In other words, 99,97 % of 783

USERS would stop trying to make the misconnection before achieving a force sufficient to make a misconnection. 784

At this point, the USER would experience a misconnection from which 87 % of the infusate would leak. 785

6050403020100

50 X 21.4838N 28

PPM > USL 38329.35

786

Figure G.1 — Force at which USERS would stop forcing a misconnection 787

788

605856545250

50

X 55.6767N 30StDev 2.39506

PPM < LSL 8890.39

789

Figure G.2 — Force required to misconnect female N2 to female E1 790

791

96 % 4 %

99,2 % > 50 N

0,8 % < 50 N

ISO/IEC DIS 80369-6


Clinicians in the formative usability study evaluated a grossly leaking CONNECTION. All the USERS in the study 792

stated they would stop administering medication if the leak was greater than 25 % of the total infusate. Most 793

stated they would stop administering medication if even a single drop leaked from the suspected misconnection 794

because the high force to misconnect would make them highly vigilant of a potential misconnection. Figure G.3 795

illustrates the leak rate at which a USER would recognize a leaking CONNECTION and stop delivering medication. 796

Less than one USER per million would be predicted to continue delivery of medication when the leak rate exceed 797

75 %. The likelihood of a USER exerting sufficient force to make a misconnection and continue to deliver 798

medication at a leak rate of 75 % is 0,03% x 0,00006 % = 0,2 wrong route delivery per billion procedures. This 799

RISK is judged to be acceptable by the combination of high connection forces and obvious leaking of the 800

misconnection. 801

7260483624120

USLUSL 75X 6N 27

PPM > USL 0.62

802

Key 803

USL = Upper specification limit 804

LSL = Lower specification limit 805

ẋ = mean 806

N = Sample size 807

PPM = Parts per million expected over USL or less than LSL 808

Figure G.3 — Leakage from a misconnection when a USER would stop 809

810

G.3 Summary of the design VERIFICATION 811

This CONNECTOR design is similar to currently marketed configurations that have been developed in the UK over 812

the last decade. The CONNECTOR design was developed based upon this work and modified to create a design 813

that was NON-INTERCONNECTABLE with the other specified CONNECTORS of this series. CONNECTORS were moulded 814

from two resins, polypropylene (elastic modulus = 960 MPa), and acrylic (elastic modulus = 2,300 MPa) which 815

span the range of available for common materials used whose modulus of elasticity meet the requirements of 4.2. 816

ISO/IEC DIS 80369-6


By testing high and low modulus of elasticity parts, the testing provides greater confidence that the full range of 817

materials, which can be to create these CONNECTORS, yield acceptable performance. 818

The CONNECTORS were tested against the performance requirements of Clause 6 in a laboratory setting. Tests 819

were performed according the methods contained in ISO 80369-20 and all tests passed demonstrating that these 820

CONNECTORS are suitable for enteral applications. This evaluation included attribute tests for liquid leakage, 821

subatmospheric-pressure air leakage and stress cracking. This evaluation included variable tests for resistance to 822

separation from axial load, resistance to separation from unscrewing and resistance to overriding. 823

Final results to be communicated by ISO/TC 210/JWG4, Small-bore connectors, subsequent to the DIS vote. An 824

“N” document will circulate prior to the completion of the DIS balloting with results from the design verification. 825

826

G.4 Summary of the design validation 827

A formative usability study was conducted in April 2014. The protocol was approved prior to the testing. Twenty 828

anaesthesiologists, six nurses and two CRNA’s were recruited from the Minneapolis, USA area. Participants were 829

asked to connect six different pairs of MEDICAL DEVICES. Some of the pairs would connect and some were 830

purposeful misconnections. A loss of resistance syringe with N2 male CONNECTOR was tested to a flat filter with a 831

N2 female CONNECTOR and also to L1 female CONNECTOR, as specified by ISO 80369-7:2014, on a similar filter. 832

Two simulated 10 ml syringes incorporated a force gauge so that the forces applied during misconnections could 833

be measured. One simulated syringe had a L1 female, as specified by ISO 80369-7:2014, machined to make a 834

misconnection with a male N2 CONNECTOR. A second simulated syringe had a machined E1 female CONNECTOR 835

that misconnected with a N2 female CONNECTOR on a filter. Participants were asked to connect neuraxial 836

CONNECTORS to the simulated syringes (purposeful misconnection) and the CONNECTION forces were recorded. 837

The average force at which USERS recognized a misconnection and stopped trying to connect was 26 N. One 838

USER did exceed 70 N (86 N). This data indicates that most physicians would recognize a misconnection well 839

below the axial load levels required by this standard. None of the 28 clinicians had problems connecting 840

neuraxial CONNECTORS to other neuraxial CONNECTORS. 841

During the same study, participants were asked to connect a 10 ml N2 syringe to a L1 female, as specified by 842

ISO 80369-7:2014, attached to a spinal needle. The 10 ml syringe was filled with water. All participants stopped 843

and commented that the CONNECTION did not seem valid. The CONNECTION was forced by either the moderator or 844

the participant and then the participant was asked to deliver medication through the 22 gauge spinal needle. The 845

misconnection leaked profusely (98 % of administrate leaked from the misconnected joint). Twenty-eight of 846

twenty-eight clinicians concluded that this misconnection was not a clinical RISK; they would have sufficient clues 847

with the difficulty to force a misconnection combined with gross leaking of the CONNECTION. 848

A summative usability study was conducted in four centres in the UK: Bridgend, Bath, Bristol, Leicester, with a 849

group of at least thirty physicians, screened for experience and skills, drawn from multiple specialties, including 850

paediatrics, oncology, anaesthesia, medicine & neurology. In addition, at least fifteen nurses, again screened for 851

experience and skills, were recruited, who have work experience in obstetrics, PACU, ICU, HDU. 852

‘Simulation rooms’ were set up: one to simulate a block-room, the second an HDU/ ICU room. The ‘block room’ 853

was equipped with a ‘spinal manikin’, to allow spinal and epidural injections to be made, epidural catheters 854

inserted and also, sampling and pressure measurement of CSF. The HDU/ICU ‘room’ was equipped with an 855

upper-body manikin, to permit line CONNECTION and misconnection attempts to be made by nurses and physicians. 856

Nurse participants were required to give bolus injections into the epidural and IV lines, set up enteral feeds, 857

neuraxial infusions, IV infusions, and bolus injections, non-invasive blood pressure measurements and oxygen 858

therapy. All procedures were videotaped for analysis, and all participants gave their consent to this. 859

Instructions for performing all tasks were prepared for physicians and nurses. Questionnaires were prepared to 860

assess usability using Likert scores. All procedures were observed and assistance by moderators was available 861

for participants. Post-task Interviews of all participants were held, and specific questions were asked of all 862

participants regarding usability and assess the change from Luer systems to non-Luer. 863

ISO/IEC DIS 80369-6


Final results to be communicated by ISO/TC 210/JWG4, Small-bore connectors, subsequent to the DIS vote. An 864

“N” document will circulate prior to the completion of the DIS balloting with results from the validation. 865

866

G.5 Summary of the design review 867

To be completed by ISO/TC 210/JWG4, Small-bore connectors, subsequent to the DIS vote. 868

869

ISO/IEC DIS 80369-6


Annex H 870

871

(informative) 872

873

Mechanical tests for verifying NON-INTERCONNECTABLE characteristics 874

H.1 * Purpose 875

ISO 80369-1:2010, Annex B, specifies the TEST METHOD and acceptance criteria to be used to obtain OBJECTIVE 876

EVIDENCE to demonstrate NON-INTERCONNECTABLE characteristics between a SMALL-BORE CONNECTOR being 877

evaluated and other SMALL-BORE CONNECTORS likely to be found in the environment around the PATIENT. This TEST 878

METHOD utilizes physical force testing between the CONNECTOR being evaluated and metal reference CONNECTORS 879

for each of the other SMALL-BORE CONNECTORS specified in this family of standards. This TEST METHOD forcefully 880

attempts to create a CONNECTION and then, should a CONNECTION occur, expects that the SMALL-BORE CONNECTOR 881

being evaluated and the reference CONNECTOR easily disengage from each other. 882

This standard modifies that TEST METHOD from ISO 80369-1:2010, Annex B, for neuraxial SMALL BORE CONNECTORS. Both the 883

detailed methodology of the test and the acceptance criteria are modified. 884

H.2 Requirement 885

The neuraxial SMALL-BORE CONNECTOR shall not appear to provide a secure CONNECTION when forcefully 886

assembled to any surface of the components of, and shall easily disengage from each SMALL-BORE CONNECTOR of 887

every other APPLICATION category specified in the ISO 80369-1:2010 or should a neuraxial CONNECTOR engage, 888

then greater than 75% of the infusate shall leak from the misconnection between the neuraxial CONNECTOR and 889

the reference SMALL-BORE CONNECTOR. 890

H.3 TEST METHOD 891

For the purposes of this test, the CONNECTORS above, other than the neuraxial CONNECTOR being evaluated, shall 892

be made of RIGID MATERIAL using nominal dimensions or may be reference CONNECTORS as specified in other 893

parts of this series of standards. 894

H.4 Test procedure, physical force 895

Check compliance with the following test. 896

a) Condition the CONNECTOR under test at 23 °C ±2 °C and a relative humidity of 50 % ±5 % for not less than 897

1 h. 898

b) Assemble the SMALL-BORE CONNECTOR to the reference CONNECTOR by applying an axial compressive force at 899

a rate of approximately 10 N/s not exceeding (70 ± 1) N and a simultaneous torque not exceeding 0,12 N·m 900

to a limit of no less than 270° of rotation or whichever comes first. 901

c) Hold the maximum assembly force and torque for no less than 10 s. 902

NOTE The requirement from ISO 80369-1:2010 was 70 N and a torque not exceeding 0,12 N·m to a limit of no more 903

than 90° of rotation. 904

ISO/IEC DIS 80369-6


d) Without activation of any latch or disengagement mechanism, apply an axial force of separation to the 905

assembled CONNECTORS to either 0,02 N or the weight of the part. 906

e) Confirm that the assembled CONNECTORS disengage. 907

f) If CONNECTORS do not disengage, without disrupting the CONNECTION, perform the CONNECTOR incompatibility 908

test (gross leak at misconnection) of H.5. 909

H.5 * Test procedure, CONNECTOR incompatibility (gross leakage) 910

H.5.1 Apparatus 911

The following items shall be utilized. 912

a) The male or female CONNECTOR under test. 913

b) The appropriate reference CONNECTOR. 914

c) An axial force meter and torque meter capable of measuring a simultaneous axial force of 70 N and 915

0.12 N·m. 916

d) A pressure source 917

EXAMPLE A syringe complying with ISO 7886-1. 918

e) A simulated or actual 22 gauge (0,42 mm inner diameter) x 90 mm spinal needle. 919

NOTE A length of hypodermic or similar tubing can be used to simulate the spinal needle such that the hypodermic 920

tubing has a maximum inner diameter of 0,43 mm and a length of (90 ± 3) mm. 921

f) A length of tubing able to create a leak proof seal between the CONNECTOR under test and the simulated 922

spinal needle 923

g) A weigh pan 924

h) A gram scale 925

H.5.2 Procedure 926

Check for CONNECTOR incompatibility with the following test. 927

a) Assemble the SMALL-BORE CONNECTOR to the reference CONNECTOR by applying an axial compressive force at 928

a rate of approximately 10 N/s not exceeding (70 ± 1) N and a simultaneous torque not exceeding 0,12 N·m 929

to a limit of no less than 270° of rotation or whichever comes first. 930

b) Hold the maximum assembly force and torque for no less than 10 s. 931

NOTE If the neuraxial CONNECTOR and reference CONNECTOR are pre-attached for the physical test described in 932

section H.4, they do not need to be assembled a second time. 933

c) Assemble the apparatus as shown in Figure H.1. 934

d) Prime the CONNECTOR under test, the reference CONNECTOR, connecting tubing and the simulated needle 935

with water by filling the circuit until water drips from the end of the needle. 936

e) Place a 10 ml syringe on the scale and zero the scale by pressing the tare button. 937

ISO/IEC DIS 80369-6


f) Fill the syringe with 7 ml ± 0.2 ml of water. 938

g) Weigh the filled syringe on the scale and record this weight as W1 (syringe water only) 939

h) Press the filled syringe into the reference CONNECTOR. 940

i) Confirm that the CONNECTION between the syringe and the reference CONNECTOR does not leak water during 941

the test. 942

j) Place the weigh pan onto the scale and zero the scale by pressing the tare button. 943

k) Place the weigh pan under the needle such that water that emerges from the needle will be collected in the 944

weigh pan. 945

l) Slowly depress the syringe plunger such that the water is fully expelled in 7 s to 15 s. 946

m) Weigh the pan with water collected from the end of the needle. Record this weight as W2. This represents 947

the water that did not leak from the misconnected CONNECTORS. 948

n) Calculate the percentage water leaking, Lw from the CONNECTION using Equation H.1. 949

Lw = 1(1 / ) 1002W W (H.1) 950

o) Confirm that the percent water leaking from the test CONNECTION exceeds 75 %. 951

952

Key 953

1. Pressure source (e.g. syringe) 954

2. Reference CONNECTOR 955

3. Neuraxial CONNECTOR under test 956

4. Tubing 957

5. 22 gauge (0,42 mm inner diameter) x 90 mm long hypodermic tube 958

6. Weigh pan 959

Figure H.1 — CONNECTOR incompatibility test set up 960

ISO/IEC DIS 80369-6


Annex I 961

962

(informative) 963

964

Reference to the Essential Principles 965

This document has been prepared to support the essential principles of safety and performance as intended to be 966

used for CONNECTIONS for neuraxial APPLICATIONS, according to ISO/TR 16142. This document is intended to be 967

acceptable for conformity assessment purposes. 968

Compliance with this document provides one means of demonstrating conformance with the specific essential 969

principles of ISO/TR 16142. Other means are possible. Table I.1 maps the clauses and subclauses of this 970

document with the essential principles of ISO/TR 16142:2006. 971

Table I.1 — Correspondence between this document and the essential principles (1 of 2) 972

Essential principle of ISO/TR 16142:2006

Corresponding clause(s)/sub-clause(s) of this document

Qualifying remarks/Notes

A.1 — Not applicable






A.7.1 — Not applicable




A.7.5 4, 5, 6

A.7.6 4, 5, 6


A.8.1.1 — Not applicable







A.9.1 4, 5, 6



973

ISO/IEC DIS 80369-6


Table I.1 — (2 of 2) 974

Essential principle of ISO/TR 16142:2006

Corresponding clause(s)/sub-clause(s) of this document






















A.12.7.4 4, 5, 6



A.12.8.2 4, 5, 6




975

976

ISO/IEC DIS 80369-6


Bibliography 977

[1] ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical 978

equipment – Part 1: General requirements 979

[2] ISO 3040:1990, Technical drawings — Dimensioning and tolerancing — Cones 980

[3] IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and 981

essential performance 982

[4] IEC 60601-1-11:—, Medical electrical equipment – Part 1-11: General requirements for basic safety and 983

essential performance – Collateral Standard: Requirements for medical electrical equipment and medical 984

electrical systems used in the home healthcare environment 985

[5] CEN CR 13825, Luer connectors - A report to CEN CHeF from the CEN forum task group “Luer fittings” 986

[6] Department of Health (England). HSC 2008/001: Updated national guidance on the safe administration of 987

intrathecal chemotherapy. 2008. Available at988

http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_086870 989

[7] COOK T.M. et al. A simulation based evaluation of two proposed alternatives to Luer devices for use in 990

Neuraxial anaesthesia, Anaesthesia 2010 65, pp. 1074 991

[8] Drake JM and Crawford MW. Near-miss injection of an anesthetic agent into a cerebrospinal fluid external 992

ventricular drain: special report. Neurosurgery 2005; 56:E1161 993

[9] Food and Drug Administration. Look, Check and Connect. Safe medical device connections save lives. 994

Medical Devices Calendar 2009. Available at http://www.fda.gov/CDRH/luer/casestudies2009-luer.pdf 995

[10] GOODMAN EJ, HAAS AJ, KANTOR GS. Inadvertent administration of magnesium sulphate through the 996

epidural catheter; report and analysis of a drug error. In J Obstet Anesth 2006; 15: 63-7 997

[11] HEW CM, CYNA AM, SIMMONS SW. Avoiding inadvertent epidural injection of drugs intended for epidural 998

use. Anaesth Intensive Care 2003, 31: 44-29 999

[12] Institute for Safe Medication Practices – Canada. Safety Bulletin. Published data supports dispensing 1000

vincristine in minibags as a system safeguard. 3rd October 2001. Available at http://www.ismp-1001

canada.org/download/safetyBulletins/ISMPCSB2001-10vincristine.pdf 1002

[13] JONES R, SWALES HA, LYONS GR. A national survey of safe practice with epidural analgesia in obstetric 1003

units, Anaesthesia 2008; 63:516-9 1004

[14] KARACA S, UNLUSOV EO. Accidental injection of intravenous bupivacaine. Eur J Anaesthesiol 2002; 1005

19:616-7 1006

[15] KHAN EI, KHADIJAH I. Intravenous bupivacaine infusion; an error in administration – a case report. Middle 1007

East Journal of Anaesthesia 2008;19:1399-400 1008

[16] National Patient Safety Agency. Patient Safety Alert 21. Safer Practice with Epidural Injections and 1009

Infusions. 2007. Available at 1010

http://www.npsa.nhs.uk/nrls/alerts-and-directives/alerts/epidural-injections-and-infusions/ 1011

[17] New South Wales Health. Safety Alert 04/06. Safe Use of vincristine. August 2006. Available at 1012

http://www.health.nsw.gov.au/quality/sabs/pdf/vincristine0906.pdf 1013

ISO/IEC DIS 80369-6


[18] The Joint Commission (USA)/ Sentinel Event Alert. Preventing vincristine administration errors. 14th July 1014

2005. Available at 1015

http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_34.htm 1016

[19] The Telegraph, Calcutta, India. Cancer patient dies after wrong injection. 10th July 2008. Available at 1017

http://www.telegraphindia.com/1080710/jsp/calcutta/story_9527857.jsp 1018

[20] World Health Organisation. Information Exchange system. Alert 115. Vincristine (and other vinca 1019

alkaloids) should only be given intravenously via a minibag. July 2007. Available at 1020

http://www.who.int/patientsafety/highlights/PS_alert_115_vincristine.pdf 1021

1022

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Terminology - Alphabetized index of defined terms 1023

ACCESSORY ..................................................................................................... ISO 80369-1:2010, definition 3.1 1024

APPLICATION .................................................................................................... ISO 80369-1:2010, definition 3.2 1025

CONNECTION ................................................................................................... ISO 80369-1:2010, definition 3.4 1026

CONNECTOR .................................................................................................... ISO 80369-1:2010, definition 3.5 1027

HARM ............................................................................................................. ISO 14971:2007, definition 2.2 1028

INTENDED USE ...................................................................................................... ISO 14971:2007, definition 2.5 1029

LOCK CONNECTOR ........................................................................................................................................... 3.1 1030

MANUFACTURER ................................................................................................... ISO 14971:2007, definition 2.8 1031

MEDICAL DEVICE ................................................................................................... ISO 14971:2007, definition 2.9 1032

NON-INTERCONNECTABLE ................................................................................. ISO 80369-1:2010, definition 3.6 1033

NORMAL USE ................................................................................................................................................... 3.2 1034

PATIENT .......................................................................................................... ISO 80369-1:2010, definition 3.7 1035

PROCEDURE ...................................................................................................... ISO 14971:2007, definition 2.12 1036

PROCESS ....................................................................................................... ISO 80369-1:2010, definition 3.17 1037

RATED ......................................................................................................................................................... 3.3 1038

RESPONSIBLE ORGANIZATION ............................................................................ ISO 80369-1:2010, definition 3.8 1039

RISK ........................................................................................................... ISO 14971:2007, definition 2.16 1040

RISK ANALYSIS .................................................................................................... ISO 14971:2007, definition 2.17 1041

RISK MANAGEMENT FILE ...................................................................................... ISO 14971:2007, definition 3.23 1042

RIGID MATERIAL ................................................................................................ ISO 80369-1:2010, definition 3.9 1043

SEMI-RIGID MATERIAL ...................................................................................... ISO 80369-1:2010, definition 3.10 1044

SLIP CONNECTOR ............................................................................................................................................ 3.4 1045

SMALL-BORE .................................................................................................. ISO 80369-1:2010, definition 3.11 1046

TYPE TEST .......................................................................................................... ISO 80369-20:—, definition 3.2 1047

USER ......................................................................................................................................................... 3.5 1048

USER PROFILE ................................................................................................................................................. 3.6 1049

VERIFICATION ..................................................................................................... ISO 14971:2007, definition 2.28 1050

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Annex ZA 1052

1053

(informative) 1054

1055

Relationship between this Document and the Essential Requirements of EU 1056

Directive 93/42/EEC 1057

[Secretariats Note: This “strawman” Annex ZA is included as a placeholder only. A formal proposal regarding this 1058

Annex will be prepared by CEN for inclusion in the Enquiry version of this part of ISO 80369. Annex ZA only 1059

applies to the CEN version of this standard and will not be included in the final ISO standard. Comments on 1060

Annex ZA should be sent to CEN for consideration and not included with national member comments on the ISO 1061

standard.] 1062

By agreement between ISO and CEN, this CEN Annex is included in the DIS and the FDIS but will not appear in 1063

the published ISO document. 1064

This document has been prepared under a mandate given to CEN by the European Commission and the 1065

European Free Trade Association to provide a means to conforming to Essential Requirements of the New 1066

Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the 1067

Member States concerning medical devices” (Medical Device Directive). 1068

Once this document is cited in the Official Journal of the European Communities under that Directive and has 1069

been implemented as a national standard in at least one Member State, compliance with the clauses of this 1070

document given in Table ZA.1 confers, within the limits of the scope of this document, a presumption of 1071

conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. 1072

Table ZA.1 — Correspondence between this document and Directive 93/42/EEC 1073

Clause(s)/sub-clause(s) of this Document

Essential requirements (ERs) of EU Directive 93/42/EEC


4, 5, 6 7.5

4, 5, 6 7.6

4, 5, 6 9.1

4, 5, 6 12.7.4

4, 5, 6 12.8.1

1074

WARNING: Other requirements and other EU Directives may be applicable to the products falling within the 1075

scope of this document. 1076

For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery, in 1077

accordance with Article 3 of Directive 93/42/EEC the following Table ZA.2 details the relevant essential health 1078

and safety requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than 1079

those of Directive 93/42/EEC along with the corresponding clauses of this Document. Table ZA.2, however, does 1080

not imply any citation in the OJEU under the machinery directive and thus does not provide presumption of 1081

conformity for the machinery directive. 1082

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Table ZA.2 — Relevant Essential Health and Safety Requirements (EHSRs) from Directive 2006/42/EC on 1083

machinery that are addressed by this document 1084

Clause(s)/sub-clause(s) of this Document

EHSR of 2006/42/EC Qualifying remarks/Notes

4, 5, 6 1.5.4

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ISO DIS 80369-6 - Small Bore Connectors for Liquids and Gases in Healthcare Applications - Part 6-...

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