AAMI Technical Standards Committees - Amazon...

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AAMI Technical Standards Committees

(Updated April 2018)

I. Anaesthetic and Respiratory .................................................................................................................................................................. 2

II. Active Medical Implants ........................................................................................................................................................................ 4

III. Biological Evaluation of Medical Devices ............................................................................................................................................. 5

IV. Cardiovascular Implants (non-active) and Extracorporeal Systems .................................................................................................... 7

V . Devices for Injection and Transfusion ................................................................................................................................................... 9

VI. Electromedical Devices ..................................................................................................................................................................... 12

VII. General Requirements for Medical Devices ..................................................................................................................................... 16

VIII. Medical Device Connectors ............................................................................................................................................................. 19

IX . Medical Device Software and IT and/or Health Software and HIT ..................................................................................................... 20

X . Sterilization and Infection Prevention – Equipment ............................................................................................................................ 22

XI. Sterilization and Infection Prevention – Hospital Practices and Instructions ...................................................................................... 24

XII. Sterilization and Infection Prevention – Industrial Processes .......................................................................................................... 26

XIII . Tissue Product Safety ..................................................................................................................................................................... 28

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I. Anaesthetic and Respiratory Committee

Code Committee Name Serves as U.S. Mirror Committee

(TAG or U.S. consensus body) for… Scope

AR Anaesthetic and Respiratory Equipment

ISO/TC 121 and related working groups Develops standards for anaesthetic and respiratory equipment and supplies, related devices and supply systems. Parent committee to the Anaesthetic and Respiratory Equipment (AR) working groups to which the standards are balloted. Staff contact: Colleen Elliott [email protected]

AR/WG 01 Anaesthetic Systems ISO/TC 121/SC 1 and related working groups

Develops performance and safety standards for breathing attachments and anaesthetic machines. Staff contact: Colleen Elliott [email protected]

AR/WG 02 Airways and Related Equipment

ISO/TC 121/SC 2 and related working groups (WG 1 through WG 10)

Develops performance and safety standards for laryngoscopic fittings, airway hazards during laser surgery, breathing circuits and tubing, nebulizing systems and components, suction catheters, respiratory therapy tubing and connectors, tracheostomy tubes, tracheal tubes. Staff contact: Colleen Elliott [email protected]

AR/WG 03 Respirator Gas Measurement, Control and Biocompatibility

ISO/TC 121/SC 3/WG 03



Develops performance and safety standards related to heat and moisture control, gas flow measurement and control and biocompatibility or respiratory gas pathways. Staff contact: Colleen Elliott [email protected]

AR/WG 04 Anaesthetic Terminology and Semantics

ISO/TC 121/SC 4 and

ISO/TC 121/WG1

Develops standards related to anaesthetic terminology and semantics. Staff contact: Colleen Elliott [email protected]

AR/WG 06 Medical gas systems ISO/TC 121/SC 6

Develops performance and safety standards for medical gas systems. Staff contact: Colleen Elliott [email protected]

AR/WG 08 Suction Devices for Hospital and Emergency Care

ISO/TC 121/SC 8 Develops performance and safety standards for suction devices for hospital and emergency care. Staff contact: Colleen Elliott [email protected]

mailto:[email protected]







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I. Anaesthetic and Respiratory Committee



EV/WG 01 Anesthesia Equipment Working Group

IEC/SC 62D/JWG 2— ISO/TC 121/SC 1 JWG 1

IEC/SC 62A/JWG 5— ISO/TC 121/SC 3 JWG 5

Develops standards dealing with anesthesia workstations and physiologic closed-loop controllers. Staff contact: Hae Choe [email protected]

EV/WG 09 Lung Ventilators Working Group IEC/SC 62D/JWG 6— ISO/TC 121/SC 1 JWG 6

IEC/SC 62D/JWG 1— ISO/TC 121/SC 3 JWG 1

IEC/SC 62D/JWG 5— ISO/TC 121/SC 3/JWG 10

IEC/SC 62D/JWG 12— ISO/TC 121/SC 3/JWG 12

Develops standards dealing with critical care ventilators, oximeters, respiratory gas monitors, and home respiratory equipment. Staff contact: Hae Choe [email protected]



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II. Active Medical Implants

Committee Code

Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body) for…

Scope

CI Cochlear Implants Committee ISO TC 150/SC 6/WG 03 Develops performance and safety standards for cochlear implants. Staff contact: Colleen Elliott, [email protected]

IP Implantable Infusion Pumps Committee

ISO/TC 150/SC 6/WG 04 Develops standards that relate to implantable infusion pumps. Staff contact: Jennifer Moyer [email protected]

MC Mechanical Circulatory Support Systems Committee

ISO/TC 150/SC 6/WG 06 Develops standards that specify requirements for safety and performance of active implantable circulatory support devices. Staff contact: Cliff Bernier [email protected]

NS/WG 02 Implantable Neurostimulators Working Group

Develops standards that relate to implantable neurostimulators regardless of therapy type. Staff contact: Jennifer Moyer [email protected].

PC Cardiac Rhythm Management Device Committee

ISO/TC 150/SC 6— IEC/SC 62D JWG 1

Develops standards related to the design and safety of implantable cardioverter defibrillators and implantable pacemakers. Staff contact: Jennifer Moyer [email protected]

PC WG01 Transvenous Cardiac Leads Working Group

Develops test methods related to transvenous cardiac leads reliability. Staff contact: Jennifer Moyer [email protected]

PC WG02 EMC Test Protocols for Pacemakers, ICDs & CRTs Working Group

ISO/TC 150/SC 6— IEC/SC 62D JWG 1

Develops test protocols related to the electromagnetic compatibility of cardiac pacemakers, cardioverter defibrillators and cardiac resynchronization devices. Staff contact: Jennifer Moyer [email protected]

PC WG03 Pacemaker and ICD MRI Compatibility Working Group

Develops methods to assess the safety of MRI and implantable cardiac devices. Staff contact: Jennifer Moyer [email protected]

TAG 150/SC 6

Active Implantable Medical Devices Committee

ISO/TC 150/SC 6 and ISO/TC 150/SC 6/JWG 2—IEC 62B JWG 1

Develops standards that impact all active implantable devices. Staff contact: Jennifer Moyer [email protected]










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III. Biological Evaluation of Medical Devices

Committee Code


Scope

BE Biological Evaluation Committee ISO/TC 194 Standardization of the approach to biological evaluation of medical and dental materials and devices together with standardization of biological test methods applicable to those materials and devices. Staff contact: Amanda Benedict [email protected]

BE/WG 01 Systematic Approach to Biological Evaluation and Terminology Working Group

ISO/TC 194/WG 01 Addresses the systematic approach to biological evaluation and terminology. Staff contact: Amanda Benedict [email protected]

BE/WG 02 Degradation Aspects Related to Biological Testing Working Group

ISO/TC 194/WG 02 Addresses degradation aspects related to biocompatibility testing. Amanda Benedict [email protected]

BE/WG 03 Animal Protection Aspects Working Group

ISO/TC 194/WG 03 Addresses animal protection aspects in biocompatibility evaluation. Staff contact: Amanda Benedict [email protected]

BE/WG 04 Clinical Investigations Working Group ISO/TC 194/WG 04 Addresses biocompatibility related clinical investigations. Staff contact: Amanda Benedict [email protected]

BE/WG 05 Cytotoxicity Working Group ISO/TC 194/WG 05 Addresses cytotoxicity testing. Staff contact: Amanda Benedict [email protected]

BE/WG 06 Mutagen, Carcinogen, Reproduction toxicity Working Group

ISO/TC 194/WG 06 Addresses mutagenicity, carcinogenicity, and reproductive toxicity testing of medical devices. Staff contact: Amanda Benedict [email protected]

BE/WG 07 Systemic Toxicity Working Group ISO/TC 194/WG 07 Addresses systemic toxicity testing. Staff contact: Amanda Benedict [email protected]

BE/WG 08 Irritation and Sensitization Working Group

ISO/TC 194/WG 08 Addresses irritation and sensitization testing. Staff contact: Amanda Benedict [email protected]










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III. Biological Evaluation of Medical Devices

Committee Code


Scope

BE/WG 09 Effects on Blood Working Group ISO/TC 194/WG 09 Addresses evaluation of the effects on blood. Staff contact: Amanda Benedict [email protected]

BE/WG 10 Implantation Working Group ISO/TC 194/WG 10 Addresses implantation testing as part of biological evaluation. Staff contact: Amanda Benedict [email protected]

BE/WG 11 Allowable Limits for Leachable Substances Working Group

ISO/TC 194/WG 11 Addresses the determination of allowable limits for leachable substances. Staff contact: Amanda Benedict [email protected]

BE/WG 12 Sample preparation and reference materials Working Group

ISO/TC 194/WG 12 Addresses sample preparation and reference materials for biocompatibility testing. Staff contact: Amanda Benedict [email protected]

BE/WG 13 Toxicokinetics Study Design Working Group

ISO/TC 194/WG 13 Addresses toxicokinetics study design. Staff contact: Amanda Benedict [email protected]

BE/WG 14 Material Characterization Working Group

ISO/TC 194/WG 14 Addresses material characterization. Staff contact: Amanda Benedict [email protected]

BE/WG 15 Strategic Approach to Biological Assessment

ISO/TC 194/WG 15 Addresses strategic approaches to biological assessment. Staff contact: Amanda Benedict [email protected]

BE/WG 16 Pyrogenicity Working Group ISO/TC 194/WG 16 Addresses pyrogenicity testing and evaluation. Staff contact: Amanda Benedict [email protected]

BE/WG 17 Nanomaterials Working Group ISO/TC 194/WG 17 Addresses nanomaterials. Staff contact: Amanda Benedict [email protected]










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IV. Cardiovascular Implants (Non-Active) and Extracorporeal Systems

Committee Code


Scope

BF Blood Filter/Cell Salvaging Committee

Develops essential performance and safety standards related to Blood filtering and transfusion. Staff contact: Cliff Bernier [email protected]

BG Blood/Gas Exchange Device Committee

ISO/TC 150/SC 2/WG 04 Develops essential performance and safety standards related to Blood/gas exchange devices; oxygenators; extracorporeal perfusion and circulation; cardiopulmonary bypass; ECMO. Staff contact: Cliff Bernier [email protected]

CO Cardiac Occluders Committee ISO/TC 150/SC 2/WG 08 Develops essential performance and safety standards related to cardiac occluders. Staff contact: Cliff Bernier [email protected]

CV Cardiac Valve Prostheses Committee ISO/TC 150/SC 2/WG 01 Develops essential performance and safety standards related to Heart valve substitutes; heart valve repair devices. Staff contact: Cliff Bernier [email protected]

DP Medical Device Particulates Committee

Develops essential performance and safety standards related to Vascular exposure to particles arising from the manufacturing environment for vascular medical devices and from the use of vascular medical devices. Staff contact: Cliff Bernier [email protected]

RD Renal Disease and Detoxification Committee

ISO/TC 150/SC 2/WG 05 Develops essential performance and safety standards related to Hemodialysis and related therapies equipment; dialysis fluid quality, preparation, and management. Staff contact: Cliff Bernier [email protected]

TAG 150/SC 2

Cardiovascular Implants and Extracorporeal Systems Committee

ISO/TC 150/SC 2 Develops essential performance and safety standards related to General technical advice on common cardiovascular implants and extracorporeal systems issues. Staff contact: Cliff Bernier [email protected]







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IV. Cardiovascular Implants (Non-Active) and Extracorporeal Systems

Committee Code


Scope

VI Cardiovascular Absorbable Implants Committee

ISO/TC 150/SC 2/WG 07 Develops essential performance and safety standards related to Absorbable cardiovascular implants. Staff contact: Cliff Bernier [email protected]

VP Vascular Prostheses Committee ISO/TC 150/SC 2/WG 03 Develops essential performance and safety standards related to Vascular and endovascular prostheses including stents and vena cava filters. Staff contact: Cliff Bernier [email protected]

VP/WG 01 Vascular Device/Drug Combination Products

ISO/TC 150/SC 2/WG 06 Develops essential performance and safety standards related to Vascular device-drug combination products and local regulatory guidance. Staff contact: Cliff Bernier [email protected]




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V. Devices for Injection and Transfusion

Committee Code

Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body)

for…

Scope

DI Devices for Injection Committee ISO/TC 76 and ISO/TC 84 TC 76: Develops essential performance and safety standards related to containers (such as infusion bottles and bags, injection vials, ampoules, glass cylinders, cartridges, pre-fillable syringes, etc.) application systems (such as giving sets, non-electrically driven portable infusion devices, blood collection systems, etc.) and accessories for infusion, transfusion, injection and blood processing in blood banks, terms, definitions, requirements and test methods for these devices, specifications and test methods for quality and performance of their materials and components (such as elastomeric closures, caps and ports, pipettes, etc.) and quality management systems for primary packaging materials.

TC84: Develops essential performance and safety standards related to performance of metered devices and supplies intended for administration of medicinal products, and standardization of syringes, needles, and intravascular catheters.

Staff contact: Cliff Bernier [email protected]

DI/WG 01 Soft Containers for Blood; Blood Processing Equipment Working Group

ISO/TC 76/WG 1 Develops essential performance and safety standards related to Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment. Staff contact: Cliff Bernier [email protected]



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Committee Code


for…

Scope

DI/WG 02 Rigid Container Systems and Accessories Working Group

ISO/TC 76/WG 2 Develops essential performance and safety standards related to Rigid container systems and related accessories for parenterals and injectables. Staff contact: Cliff Bernier [email protected]

DI/WG 04 Elastomeric Parts, Components and Packaging Working Group

ISO/TC 76/WG 4 Develops essential performance and safety standards related to Elastomeric parts and components and related secondary packaging components. Staff contact: Cliff Bernier [email protected]

DI/WG 05 Blood Collection Systems Working Group

ISO/TC 76/WG 5 Develops essential performance and safety standards related to Blood collecting systems for diagnostic use. Staff contact: Cliff Bernier [email protected]

DI/WG 06 Primary Packaging Materials for Medicinal Products Working Group

ISO/TC 76/WG 6 Develops essential performance and safety standards related to Primary packaging materials for medicinal products. Staff contact: Cliff Bernier [email protected]

DI/WG 23 Syringes for Insulin and Pen Injectors Working Group

ISO/TC 84/WG 3 Develops essential performance and safety standards related to Syringes for insulin and pen-injectors. Staff contact: Cliff Bernier [email protected]

DI/WG 24 Needle Free Injectors Working Group ISO/TC 84/WG 4 Inactive

DI/WG 26 Auto Injectors Working Group ISO/TC 84/WG 6 Inactive

DI/WG 27 Safety Issues for Needles Working Group

ISO/TC 84/WG 7 Inactive

DI/WG 28 Sharps Containers Working Group ISO/TC 84/WG 8 Develops essential performance and safety standards related to Sharps containers. Staff contact: Cliff Bernier [email protected]







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Committee Code


for…

Scope

DI/WG 29 Catheters Working Group ISO/TC 84/WG 9 Develops essential performance and safety standards related to Catheters. Staff contact: Cliff Bernier [email protected]

DI/WG 30 Needles Working Group ISO/TC 84/WG 10 Develops essential performance and safety standards related to Needles. Staff contact: Cliff Bernier [email protected]

DI/WG 31 Syringes Working Group ISO/TC 84/WG 11 Develops essential performance and safety standards related to Syringes. Staff contact: Cliff Bernier [email protected]

DI/WG 32 Requirements for NIS: Accessibility for Physical Impairments Working Group

ISO/TC 84/WG 12 Develops essential performance and safety standards related to Accessibility for visually impaired. Staff contact: Cliff Bernier [email protected]

DI/WG 33 On-Body Delivery Systems Working Group

ISO/TC 84/WG 13 Develops essential performance and safety standards related to Bolus injection. Staff contact: Cliff Bernier [email protected]

DI/WG 34 Needle-based injection system (NIS) - Electrotechnical requirements and test methods

ISO/TC 84/WG 14 Develops essential performance and safety standards related to Electrotechnical requirements and test methods for Needle-based injection systems. Staff contact: Cliff Bernier [email protected]

DI/WG 35 Device Change Management ISO/TC 84/WG 15 Develops guidelines for device change management. Staff contact: Cliff Bernier [email protected]

DI/WG 36 Drug Delivery System Requirements for Paedriatics and Other Demographics

ISO/TC 84/WG 16 Develops essential performance and safety standards for drug delivery systems for paedriatrics and other demographics. Staff contact: Cliff Bernier [email protected]








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VI. Electromedical Devices

Committee Code Committee Name Serves as U.S. Mirror Committee (TAG or U.S. consensus body)

for…

Scope

AP Apnea Monitoring Committee Develops reports regarding apnea monitoring by means of thoracic impedance pneumography. Staff contact: Hae Choe [email protected]

BP Blood Pressure Monitoring Committee

IEC/SC 62D/JWG22 Develops standards dealing with invasive blood pressure monitoring devices. Staff contact: Hae Choe [email protected]

DF Defibrillator Committee IEC/SC 62D/MT19 Develops standards dealing with cardiac defibrillators and automated external defibrillators. Staff contact: Hae Choe [email protected]

EC ECG Committee IEC/SC 62D/JWG22 Develops standards dealing with diagnostic, cardiac, and ambulatory electrocardiographic (ECG) monitoring equipment as well as the cables and leadwires, arrhythmia monitoring and electrodes used in electrocardiographs. Staff contact: Hae Choe [email protected]

EQ Medical Equipment Management Committee

Develops standards on aspects of medical equipment management for healthcare technology managers. Staff contact: Patrick Bernat [email protected] or Joe Lewelling [email protected]

EV/WG 02 Electroencephalographs Equipment IEC/SC 62D/JWG22 Develops standard on electroencephalographs. Staff contact: Hae Choe [email protected]

EV/WG 03 EMG and Evoked Response Equipment Working Group

IEC/SC 62D/MT26 Develops standard on electromyographs and evoked response equipment. Staff contact: Hae Choe [email protected]

EV/WG 04 Electro-optical Equipment Working Group

IEC/SC 62D/MT16 Develops standard on endoscopic equipment. Staff contact: Hae Choe [email protected]










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for…

Scope

EV/WG 05 Hospital Bed Working Group IEC/SC 62D — ISO/TC 173 JWG 4

Develops standards on medical beds and operating tables. Staff contact: Hae Choe [email protected]

EV/WG 06 Clinical Thermometers IEC/SC 62D/JWG 8 — ISO/TC 121/SC 1 JWG 6

Develops standards on clinical thermometers and screening thermographs for human febrile temperature screening. Staff contact: Hae Choe [email protected]

EV/WG 07 Transcutaneous Partial Pressure Monitoring Equipment Working Group

IEC/SC 62D/JWG22 Develops standard on transcutaneous partial pressure monitoring equipment. Staff contact: Hae Choe [email protected]

EV/WG 08 Ultrasound Working Group IEC/SC 62D/JWG38

IEC/SC 62D/MT24

Develops standards on ultrasound physiotherapy equipment, extracorporeally induced lithotripsy, and high intensity therapeutic ultrasound. Staff contact: Hae Choe [email protected]

EV/WG 10 Short-wave & Microwave Therapy Equipment

IEC/SC 62D/MT 18 Develops standards on short-wave therapy and microwave therapy equipment. Staff contact: Hae Choe [email protected]

EV/WG 11 Ionized Gas Coagulation Equipment

IEC/SC 62D/WG34 Develops standard for ionized gas coagulation equipment. Staff contact: Hae Choe [email protected]

EV/WG 12 Luminaires Working Group IEC/SC 62D/MT27 Develops standard on surgical luminaires and luminaires for diagnosis. Staff contact: Hae Choe [email protected]

EV/WG 13 Lens Removal and Vitrectomy Devices Working Group

IEC/SC 62D — ISO/TC 172/SC 7 JWG 9

Develops standard for lens removal and vitrectomy devices. Staff contact: Hae Choe [email protected]









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for…

Scope

EV/WG 14 Photodynamic Therapy and Diagnostic Equipment

IEC/SC 62D/WG 33 Develops standard for photodynamic therapy and diagnostic equipment. Staff contact: Hae Choe [email protected]

HF High Frequency Therapeutic Device Committee

IEC/SC 62D/MT17 Develops standards for high frequency surgical equipment. Staff contact: Hae Choe [email protected]

ID Infusion Device Committee IEC/SC 62D/MT23 Develops standards related to non-implantable infusion pumps. Staff contact: Jennifer Moyer [email protected]

II Infant Incubator Committee IEC/SC 62D/MT21 Develops standards for pediatric medical equipment such as incubators, radiant warmers, and phototherapy equipment. Staff contact: Hae Choe [email protected]

MP Multiparameter Patient Monitoring Equip Committee

IEC/SC 62D/MT22 Develops standards related to multi-function patient monitoring equipment. Staff contact: Jennifer Moyer [email protected]

NS Neurosurgery Committee Provides oversight to the working groups dealing with neurosurgery. Staff contact: Jennifer Moyer [email protected].

NS/WG 01 Intra-cranial Pressure Devices Working Group

Develops standards that relate to devices that are intended to measure intercranial pressure. Staff contact: Jennifer Moyer [email protected]

NS/WG 03 Transcutaneous Electrical Stimulator Working Group

Develops standards that establishes certain requirements for portable, battery-powered, transcutaneous electrical nerve stimulators (TENS devices). Staff contact: Jennifer Moyer [email protected]









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for…

Scope

SP Sphygmomanometer Committee IEC/SC 62D/JWG 7— ISO/TC 121/SC 3 JWG 7

Develops standards for automated and non-automated non-invasive blood pressure monitoring devices. Staff contact: Hae Choe [email protected]

TAG 62D Electromedical Equipment Committee

IEC/SC 62D Develops U.S. position for IEC/SC 62D and provides oversight to all of the committees which service as mirror committees to the work that is being undertaken by IEC/SC 62D. Staff contact: Hae Choe [email protected]

WV Waveform Testing Committee Develops technical report on acquisition and use of physiologic waveform databases for testing of medical devices. Staff contact: Hae Choe [email protected]




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VII. General Requirements for Medical Devices

Committee Code


for…

Scope

AL Alarms (Medical Device Alarms) Committee

IEC/SC 62A/JWG 2— ISO/TC 121/SC 3 JWG 2

Develops standards on auditory and visual alarm signals for medical equipment. Staff contact: Jennifer Moyer [email protected]

CP Combination Products Committee Develops standards and guidance applicable to combination products. Staff contact: Hae Choe [email protected]

EM Electromagnetic Compatibility Committee

IEC/SC 62A/MT23 Develops general electromagnetic compatibility requirements for medical electrical equipment, taking into consideration the special needs of medical practice. Staff contact: Hae Choe [email protected]

ES Electrical Safety Committee

IEC/SC 62A Develops standards that test medical electrical equipment and specifies general testing requirements. Staff contact: Hae Choe [email protected]

HA Home Use and EMS Environment IEC/SC 62A/JWG 6— ISO/TC 121/SC 6 JWG 6

Develops standards and guidance documents that provide information on design, maintenance, and use of medical devices and systems intended for the non-clinical environment in order to continually improve safety and usability. Staff contact: Jennifer Moyer [email protected]

HE Human Factors Engineering Committee

IEC/SC 62A/JWG4— ISO/TC 210/JWG 3

Develops general requirements and guidance on a usability-engineering process for improving the safety of medical devices and combinations of medical devices. Staff contact: Jennifer Moyer [email protected]







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Committee Code


for…

Scope

QM Quality Management and Corresponding General Aspects for Medical Devices Committee

ISO/TC 210 Develops standards for quality management and corresponding general aspects for medical devices. Staff contact: Wil Vargas [email protected]

QM/WG 01 Application of Quality Systems to Medical Devices Working Group

ISO/TC 210/WG 01 Develops standards for a quality management system that can be used by an organization involved in stages of the life-cycle of a medical device. Staff contact: Wil Vargas [email protected]

QM/WG 02 General Aspects Stemming from the Application of Quality Principles to Medical Devices Working Group

ISO/TC 210/WG 02 Develops standards and guides that can be used in the assessment of conformity of medical devices to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. Staff contact: Wil Vargas [email protected]

QM/WG 03 Symbols & Nomenclature for Medical Devices Working Group

ISO/TC 210/WG 03 Develops standards for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. Staff contact: Wil Vargas [email protected]

QM/WG 04 Application of Risk Management to Medical Devices Working Group

ISO/TC 210— IEC/SC 62A JWG 1

Develops standards and guidance that specify a process for a manufacturer to identify the hazards associated with medical devices to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. Staff contact: Wil Vargas [email protected]

QM/WG 06 Application of post market surveillance systems to medical devices

ISO/TC 210/WG 06 Develops standards and guidance that assist medical device manufacturers to collect and analyze experience gained with their devices after placing on the market, and identify ways to use the data. Staff contact: Wil Vargas [email protected]







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Committee Code


for…

Scope

RB Robotics ISO/TC 299 – IEC/SC 62A JWG 9

ISO/TC 299 – IEC/SC 62D JWG35

ISO/TC 299 – IEC/SC 62D JWG36

Develops standards and guidance which deal with robotic equipment with medical implications. Staff contact: Hae Choe [email protected]

SU Sustainability Committee Develops standards and guidance on sustainability as it relates to medical device development with regard to the triple bottom line: economy, environment, society. Staff contact: Cliff Bernier [email protected]

TAG 62 Electrical Equipment in Medical Practice Committee

IEC/TC 62 Develops U.S. position for IEC/TC 62. Staff contact: Hae Choe [email protected]

TAG 62A Common aspects of electrical equipment used in medical practice

IEC/SC 62A Develops U.S. position for IEC/SC 62A and working groups/maintenance teams/joint working groups under this subcommittee. Staff contact: Hae Choe [email protected]





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VIII. Medical Device Connectors

Committee Code


Scope

CN Small Bore Connectors Committee ISO/TC 210— IEC/SC 62D JWG 4

Develops design standards for small-bore connectors for healthcare applications. Staff contact: Colleen Elliott [email protected]

CN/WG 01 Luer Activated Valves Working Group Develops standards for luer activated valves/needle free connectors. Staff contact: Colleen Elliott [email protected]

CN/WG 15 Small Bore Connectors Reservoir Delivery Systems Working Group

ISO/TC 210/WG 5 Develops design standards for connectors for reservoir delivery systems for healthcare applications. Staff contact: Colleen Elliott [email protected]




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IX. Medical Device Software and IT and/or Health Software and HIT

Committee Code


Scope

AAMI/UL 2800

Interoperability Coordinates the activity for the development of a family of standards focused on component safety and security requirements for plug-and-play interoperability with medical devices. Staff contact: Wil Vargas [email protected]

HIT Health IT Committee Addresses safety, effectiveness, and security of health software and health IT. Staff contact: Joe Lewelling [email protected]

HIT/WG 01 Health IT Risk Management Addresses risk management for the health IT sociotechnical system. Staff contact: Joe Lewelling [email protected]

HIT/WG 02 Health IT Quality Systems Addresses quality systems for the health IT sociotechnical system. Staff contact: Joe Lewelling [email protected]

HIT/WG 03 Health IT Usability Addresses usability for the health IT sociotechnical system. . Staff contact: Joe Lewelling [email protected]

HIT/WG 04 Health IT Safety ISO/TC 215— IEC/SC 62A JWG 7

Coordinates the US input and US adoption of international standards for health software and health IT. Joe Lewelling [email protected]

SM Software and Information Technology Committee

Oversight committee for the AAMI software, health information technology, and interoperability working groups. Staff contact: Wil Vargas [email protected]

SM/WG 01 Software Working Group ISO/TC 210— IEC/SC 62A JWG 2 (IEC/SC 62A JWG 3)

Develops standards and guidance on medical device software. Staff contact: Wil Vargas [email protected]









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IX. Medical Device Software and IT and/or Health Software and HIT

Committee Code


Scope

SM/WG 02 Information Technology Networks Working Group

ISO/TC 215— IEC/SC 62A JWG 7

Oversees US adoption of the IEC 80001 series of standards and guides on the application of risk management for IT-networks incorporating medical devices. Staff contact: Joe Lewelling [email protected]

SM/WG03 Interoperability Working Group Addresses hazardous situations that may arise from a lack of interoperability, which includes but is not limited to the inability to communicate or an attempt to integrate systems which were not intended to be integrated. Staff contact: Wil Vargas [email protected]

SM/ WG05 Device Security Working Group Develops standards on device security as it relates to medical devices. Staff contact: Wil Vargas [email protected]

SM/WG06 Wireless Working Group Develops standards on wireless issues as they relate to medical devices. Staff contact: Staff contact: Wil Vargas [email protected]:

SM/WG08 Software Defect Classification Working Group

Develops standards relating to software defects. Staff contact: Staff contact: Wil Vargas [email protected]:






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X. Sterilization and Infection Prevention – Equipment Committee



PB Protective Barriers Committee (surgical gowns and drapes)

Develops performance standards for surgical gowns and drapes. Staff contact: Colleen Elliott, [email protected]

ST/WG 04 Biological Indicators Working Group ISO/TC 198/WG 04 Develops standards related to biological indicators. Staff contact: Cliff Bernier [email protected]

ST/WG 06 Chemical Indicators Working Group ISO/TC 198/WG 06 Develops standards related to chemical indicators. Staff contact: Cliff Bernier [email protected]

ST/WG 07 Packaging Working Group ISO/TC 198/WG 07 Develops standards related to packaging for terminally sterilized medical devices. Staff contact: Hae Choe [email protected]

ST/WG 13 Washer Disinfectors Working Group ISO/TC 198/WG 13 Develops standards and test methods for washer-disinfectors. Staff contact: Jennifer Moyer [email protected]

ST/WG 43 Hospital Steam Sterilizer Working Group

Develops standards related to the manufacturing of steam sterilizers. Staff contact: Amanda Benedict [email protected]

ST/WG 62 Hospital Ethylene Oxide Sterilizer Working Group

Develops performance and safety standards for large (> 2 cu. ft. chamber) and small steam sterilizers utilized in health care facilities to sterilize reusable medical devices. Staff contact: Amanda Benedict [email protected]

ST/WG 91 Resistometer Working Group Develops standards for test equipment to be used in testing biological and chemical indicators. Staff contact: Cliff Bernier [email protected]





mailto:Jennifer




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X. Sterilization and Infection Prevention – Equipment Committee



ST/WG 92 Process Challenge Devices Working Group

Develops technical report for process challenge devices/test packs used in healthcare facilities. Staff contact: Hae Choe [email protected]

ST/WG 94 Rigid Sterilization Container Systems Working Group

Develops standards related to the manufacturing of rigid sterile barrier systems. Staff contact: Amanda Benedict [email protected]



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XI. Sterilization and Infection Prevention – Hospital Practices and Instructions

Committee Code


Scope

ST/WG 12 Instructions for Reusable Device Reprocessing Working Group

ISO/TC 198/WG 12 Develops standards for the development, validation or verification and provision of instructions for processing medical devices in health care facilities. Staff contact: Jennifer Moyer [email protected]

ST/WG 15 Sterility Assurance Level (SAL) Working Group

ISO/TC 198/WG 15 Develops standards addressing the assurance of sterility in the processing of health care products to be labelled "sterile". Staff contact: Amanda Benedict [email protected]

ST/WG 40 Steam Sterilization Hospital Practices Working Group

Develops standards for sterile processing professionals using steam sterilization in health care delivery organizations. Staff contact: Amanda Benedict [email protected]

ST/WG 60 EO Sterilization Hospital Practices Working Group

Develops standards for sterile processing professionals using EO sterilization in health care delivery organizations. Staff contact: Amanda Benedict [email protected]

ST/WG 61 Chemical Sterilants Hospital Practices Working Group

Develops standards for sterile processing professionals using chemical sterilants in health care delivery organizations. Staff contact: Amanda Benedict [email protected]

ST/WG 63 Sterilization Residuals Working Group

Develops standards for sterile processing professionals relating to sterilization residuals in health care delivery organizations. Staff contact: Amanda Benedict [email protected]

ST/WG 83 Reusable Surgical Textiles Processing Working Group

Develops standards and guidance for processing of surgical textiles in health care facilities. Staff contact: Amanda Benedict [email protected]








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XI. Sterilization and Infection Prevention – Hospital Practices and Instructions

Committee Code


Scope

ST/WG 84 Endoscope Reprocessing Working Group

Develops guidance on endoscope reprocessing. Staff contact: Amanda Benedict [email protected]

ST/WG 85 Human Factors for Device Reprocessing Working Group

Develops guidance on human factors engineering as it relates to medical device design and instructions for use. Staff contact: Amanda Benedict [email protected]

ST/WG 86 Quality Systems for Device Reprocessing Working Group

Develops standards for quality management systems for device reprocessing in health care delivery organizations. Staff contact: Amanda Benedict [email protected]

ST/WG 93 Cleaning of Reusable Medical Devices Working Group

Develops guidance on cleaning of medical devices. Staff contact: Amanda Benedict [email protected]

ST/WG 95 Water Quality for Reprocessing Medical Devices

Develops guidance on water quality required for cleaning and reprocessing medical devices. Staff Amanda Benedict [email protected]






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XII. Sterilization and Infection Processes – Industrial Processes

Committee Code


Scope

ST Sterilization Standards Committee ISO/TC 198 Provides administrative guidance over the AAMI sterilization standards program and U.S. participation in ISO/TC 198, Sterilization of health care products. Staff contact: Amanda Benedict [email protected]

ST/WG 01 Industrial EO sterilization Working Group

ISO/TC 198/WG 01 Develops standards and guidance for ethylene oxide sterilization processes. Staff contact: Cliff Bernier [email protected]

ST/WG 02 Radiation Sterilization Working Group ISO/TC 198/WG 02 Develops standards and guidance for radiation sterilizations processes. Staff contact: Colleen Elliott [email protected]

ST/WG 03 Industrial Moist Heat Sterilization Working Group

ISO/TC 198/WG 03 Develops standards and guidance for moist heat sterilization processes. Staff contact: [email protected]

ST/WG 05 Sterilization Terminology Working Group

ISO/TC 198/WG 05 Develops terminology standards and definitions for sterilization processes and equipment. Staff contact: Amanda Benedict [email protected]

ST/WG 08 Microbiological Methods Working Group

ISO/TC 198/WG 08 Develops microbiological methods and standards used in sterilization processing. Staff contact: Jennifer Moyer [email protected]

ST/WG 09 Aseptic Processing Working Group ISO/TC 198/WG 09 Develops standards for aseptic processing of healthcare products as a production process. Staff contact: Jennifer Moyer [email protected]

ST/WG 10 Liquid Chemical Sterilization Working Group

ISO/TC 198/WG 10 Develops standards for liquid chemical sterilization and processing of medical devices incorporating animal tissue. Staff contact: Amanda Benedict [email protected]









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XII. Sterilization and Infection Processes – Industrial ProcessesCommittee



ST/WG 11 General Criteria for Sterilization Processes and Sterilizing Equipment Working Group

ISO/TC 198/WG 11 Develops standards providing general requirements for sterilization processes not addressed by other sterilization process standards. Staff contact: Amanda Benedict [email protected]

ST/WG 42 Dry Heat Sterilization Working Group Develops standards and guidance for moist heat sterilization processes. Staff contact: Amanda Benedict [email protected]

ST/WG 96 Compatibility of Materials Subject to Sterilization Working Group

Develops standards and guidance on the compatibility of various materials (e.g. metals, ceramics, polymers) with different sterilization processes. Staff contact: Amanda Benedict [email protected]

ST/WG 16 Vaporized Hydrogen PeroxideSterilization

ISO/TC 198/WG 16 Develops standards and guidance for vaporized hydrogen peroxide sterilization processes. Staff contact: Amanda Benedict [email protected]




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XIII. Tissue Product SafetyCommittee



TS Tissue Product Safety Committee ISO/TC 194/SC 1 Develops standards on tissue product safety as it relates to biological evaluation. Staff contact: Amanda Benedict [email protected]



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