Newsletter of the South Asian Regional Standards Organization

Volume 6/ Issue 02/ April – June 2020

Newsletter of the South Asian Regional Standards Organization

A Specialized Body of SAARC

MESSAGE FROM THE DIRECTOR GENERAL OF SARSO

Greetings from SARSO! I hope this Newsletter finds all in Good Health. I am pleased to

inform that SARSO Secretariat has been able to discharge its duties despite the various

constraints.

Keeping in view the importance of Standards as an invaluable tool that can be used to fight the

Pandemic, a Report comprising of a compilation of the list of available National Standards and

ISO/IEC Standards on Personal Protective Equipment and other products was prepared and

made available to all the Member States of SAARC was reference.

The newly created Working Group for having common regional stand in the International

Standards forum has found good support. India Member Body had sought the support from

SARSO Members on its proposal at ISO for the creation of a new ISO Technical Committee.

Out of the 4 members of ISO from the SAARC region, 2 member states supported the

proposal of India Member body. I look forward to more fruitful sharing of views/comments on

ISO/IEC Draft Standards such that the voice of SAARC gets due recognition in the

International Forum.

In view of the new and unforeseen situation, proposals were sought from the Governing

Board Members seeking proposals on methods to be adopted for ensuring progress in

accordance with the Meeting and Training Calendar – 2020, which has got hampered due to

the Pandemic.

Alongwith the SAARC Member States, SARSO prays for the early restoration of normal life

such that all the planned activities of SARSO can take place.


REPORT ON “NATIONAL STANDARDS OF SAARC MEMBER

STATES AND INTERNATIONAL STANDARDS TO HELP IN THE

FIGHT AGAINST COVID- 19 CRISIS IN SAARC REGION”

Among the various objectives and functions

of SARSO, one is to act as a source of

information for the Member States on

standards, regulations, conformity

assessment. In view of the rapidly spreading

coronavirus disease 2019 (COVID-19)

pandemic, SARSO had compiled the list of

important National Standards published by

SAARC Member States and published

International Standards so that it can be

used in the SAARC region as the source of

information of very important standards for

government agencies, researchers,

laboratories, consumers and manufacturers

of medical equipment and protective

products. The list of the standards has been

circulated among the member of SARSO

and also made available in the website of

SARSO.

This work of identifying the list of the very

important standards of SAARC member

States and International Standards was

based on information available in the

websites of the respective standards bodies.

In case any addition or correction is

proposed by any Member Body would be

acted upon by SARSO Secretariat, such that

this list serves as a permanent reference

point in the SARSO website. The Report is

attached

SARSO PARTICIPATES THE CEN-CENELEC PRIORITY

INDIA MEETING

Mr. Ramesh Khadka, Deputy Director of

SARSO participated on-line meeting of the

CEN-CENELEC Priority India Meeting on

23 June 2020. Mr. Khadka delivered a

presentation on the updates of SARSO’s

activities. He highlighted the objectives of

SARSO and the progress made till date


DRAFT GUIDELINE FOR SELECTION OF PROPOSED

PROJECT PROPOSALS / NEW WORK ITEMS

The Eight meeting of Governing Board of

SARSO held on 05 and 06 November 2019

in Dhaka, Bangladesh felt that apart from

the intra-regional trade, the Draft Guideline

prepared by Sri Lanka for selection of

proposed project proposals / new work

items for regional

harmonization/formulation of Regional

Standards’ should take into other holistic

issues such as, potential of the New Work

Item for furthering trade, improving health,

ensuring safety, no negative impact to

environment, addressing sustainability

concerns, achievement of UN Sustainable

Development Goals, etc. As advised by the

Governing Board of SARSO, SARSO

Secretariat incorporated a Preamble

highlighting the need for factoring the above

stated issues in the scoring system and

circulated the guide inviting appropriate

proposals from the Member States.

WORKING GROUP UNDER THE TECHNICAL MANAGEMENT

BOARD FOR EVOLVING COMMON SAARC STAND ON

INTERNATIONAL DRAFT STANDARDS, ETC.

During the Eight meeting of Governing

Board of SARSO held during 05 - 06

November 2019 in Dhaka, Bangladesh, the

Governing Board established a working

group under the Technical Management

Board with a view to have a common

regional stand on the international draft

Standards which have an impact on the

region.

This move is now bearing fruit since India

Member Body had sought support of

Members of SAARC in ISO for the creation

of a new ISO Technical Committee on

‘Security equipment used for financial

institutions and commercial organizations’,

ISO/TS/P 286. Of the Four SAARC

Members in ISO, 2 Member States had

voted in favour of the proposal.


INITIATIVE TO EXPLORE OPTIONS FOR ENSURING THE

MEETING AND TRAINING CALENDAR – 2020

In view of the current situation where the

COVID 19 pandemic continues to wreak

havoc with SARSO approved Meeting and

Training Calendar for the year 2020 and a

physical meeting, without any constraints

may be a long way off, SARSO Secretariat is

in consultation with SARSO Governing

board members for obtaining viable options

such that SARSO, through virtual means, is

able to make Progress in accordance with

the Meeting and Training Calendar – 2020.

A PANORAMIC VIEW OF A FEW EMERGING SUBJECTS IN

ISO/IEC THAT MAY BE OF INTEREST TO SAARC

COUNTRIES

S.N. ISO/IEC number Title ISO/TC or IEC/SC

number

1. ISO/DIS 19574 Footwear and footwear components —

Qualitative test method to assess antifungal activity (growth test)

TC : ISO/TC 216

2. ISO/DIS 22514-7 Statistical methods in process

management — Capability and

performance — Part 7: Capability of measurement processes

TC : ISO/TC 69/SC 4

3. ISO/IEC DIS 30145-1 Information technology — Smart City

ICT reference framework — Part 1:

Smart city business process framework

TC : ISO/IEC JTC 1

4. ISO/DIS 18650-1 Building construction machinery and

equipment — Concrete mixers — Part 1:

Terms and commercial specifications

TC : ISO/TC 195/SC 1

5. ISO/DIS 11608-2 Needle-based injection systems for

medical use — Requirements and test

methods — Part 2: Double-ended

needles

TC : ISO/TC 84

6. ISO/CD TR 17886 Fire safety engineering — Design of

evacuation experiments

TC : ISO/TC 92/SC 4

7. ISO/DIS 20414 Fire safety engineering — Verification and

validation protocol for building fire

TC : ISO/TC 92/SC 4


evacuation models

8. ISO/PRF TS 21387 Sterilization of medical devices —

Guidance on the requirements for the

validation and routine processing of

ethylene oxide sterilization processes using parametric release

TC : ISO/TC 198

ISO/DIS 44003 Guidelines for micro, small and medium-

sized enterprises on the implementation

of the principles of collaborative business

relationship management

TC : ISO/TC 286

9. ISO/DIS 23590 Household biogas system requirements:

design, installation, operation,

maintenance and safety

TC : ISO/TC 255

10. ISO/DIS 20500-1 Mobile road construction machinery —

Safety — Part 1: Common requirements

TC : ISO/TC 195

11. ISO/DIS 14931 Leather — Guide to the selection of

leather for apparel (excluding furs)


12. ISO/DIS 15886-3 Agricultural irrigation equipment —

Sprinklers — Part 3: Characterization of

distribution and test methods


13. ISO/IEC DIS 29158 Information technology — Automatic

identification and data capture techniques

— Direct Part Mark (DPM) Quality Guideline

TC : ISO/IEC JTC 1/SC 31

14. ISO/DIS 24220 Paocai (salted fermented vegetables) —

Specification and test methods

TC : ISO/TC 34/SC 3

15.

ISO/DIS 21364-1 Domestic gas cooking appliances —

Safety — Part 1: General requirements

TC : ISO/TC 291

16.

ISO/DIS 10218-1 Robotics — Safety requirements for

robot systems in an industrial

environment — Part 1: Robots

TC : ISO/TC 299

17. ISO/DIS 22166-1 Robotics — Modularity for service robots — Part 1: General requirements

TC : ISO/TC 299

18. ISO/FDIS 22904 Additions for concrete TC : ISO/TC 71/SC 3

19. ISO/DIS 80601-2-87 Medical electrical equipment — Part 2-

87: Particular requirements for basic

safety and essential performance of high-

frequency ventilators


20. ISO/DIS 23431 Measurement of road tunnel air quality TC : ISO/TC 146/SC 3

21. ISO/IEC DIS 19770-11 Information technology — IT asset

management — Part 11: Requirements

for bodies providing audit and

certification of IT asset management

systems



22. ISO/DIS 14065 Greenhouse gases — Environmental

information — Requirements for bodies

validating and verifying environmental

information


23. ISO/DIS 23043 Evaluation methods for industrial

wastewater treatment reuse processes


24. ISO/DIS 37164 Smart community infrastructures —

Smart transportation using fuel cell LRT


25. ISO/DIS 6166 Financial services — International

securities identification numbering system

(ISIN)

TC : ISO/TC 68/SC 8

26. ISO/DIS 14738 Safety of machinery — Anthropometric

requirements for the design of

workstations for industries and services


27. ISO/DIS 12345 Diesel engines — Cleanliness assessment of fuel injection equipment


28. ISO/FDIS 11193-1 Single-use medical examination gloves —

Part 1: Specification for gloves made from

rubber latex or rubber solution

TC : ISO/TC 45/SC 4

29. ISO/IEC DIS 27014 Information security, cybersecurity and

privacy protection — Governance of

information security


30. ISO/SAE DIS 21434 Road vehicles — Cybersecurity

engineering


31. ISO/DIS 18530 Health Informatics — Automatic

identification and data capture marking

and labelling — Subject of care and

individual provider identification

TC : ISO/TC 215

32. ISO/DIS 10017 Quality management — Guidance on

statistical techniques for ISO 9001:2015


33.

ISO/DIS 10013 Quality management systems —

Guidance for documented information


34. ISO/DIS 10845-1 Construction procurement — Part 1:

Processes, methods and procedures


35. ISO/PRF TS 21184 Cooperative intelligent transport

systems (C-ITS) — Global transport data

management (GTDM) framework

TC : ISO/TC 204

36. ISO/FDIS 20127 Dentistry — Physical properties of

powered toothbrushes


37. ISO/DIS 16061 Instruments for use in association with

non-active surgical implants — General

requirements

TC : ISO/TC 150

38. ISO/FDIS 31800 Faecal sludge treatment units — Energy

independent, prefabricated, community-

scale, resource recovery units — Safety

and performance requirements

TC : ISO/PC 318


39. ISO/IEC DIS 10646 Information technology — Universal

coded character set (UCS)


40. ISO/DIS 23133 Nuclear criticality safety – Nuclear

criticality safety training for operations

TC : ISO/TC 85/SC 5

41. ISO/DIS 21912 Solid recovered fuels — Safe handling and

storage of solid recovered fuels

TC : ISO/TC 300

42. ISO/DIS 22044 Commercial beverage coolers —

Classification, requirements and test

conditions

TC : ISO/TC 86/SC 7

43.

ISO/DIS 27920 Carbon dioxide capture, transportation

and geological storage (CCS) —

Quantification and Verification

TC : ISO/TC 265

44. ISO/DIS 22040 Life cycle management of concrete

structures

TC : ISO/TC 71

45. ISO/DIS 22948 Carbon footprint for seafood — Product

category rules (CFP-PCR) for finfish

TC : ISO/TC 234

46. ISO/DIS 27789 Health informatics — Audit trails for

electronic health records

TC : ISO/TC 215

47. ISO/PRF TS 16791 Health informatics — Requirements for

international machine-readable coding of

medicinal product package identifiers

TC : ISO/TC 215

48. ISO/DIS 22156 Bamboo — Structural design TC : ISO/TC 165

49. ISO/IEC DIS 20919 Information technology — Linear tape

file system (LTFS) Format specification

TC : ISO/IEC JTC 1

50. ISO/PRF TS 22756 Health Informatics — Requirements for a

knowledge base for clinical decision

support systems to be used in

medication-related processes

TC : ISO/TC 215

51. ISO/DIS 21757-1 Document management — ECMAScript

for PDF — Part 1: Use of ISO 32000-2

(PDF 2.0)


52. ISO/DIS 690 Information and documentation —

Guidelines for bibliographic references

and citations to information resources

TC : ISO/TC 46/SC 9

53. ISO/DIS 37167 Smart community infrastructures —

Smart transportation for energy saving

operation by slowly driving intentionally


54.

ISO/IEC DIS 5230 Information technology — Open Chain

Specification

TC : ISO/IEC JTC 1

55. ISO/DIS 23195 Security objectives of information

systems of third-party payment services

TC : ISO/TC 68/SC 2

56. ISO 80601-2-90 ED1

Medical electrical equipment —Part 2-90:

Particular requirements for basic safety

and essential performance of respiratory

high-flow therapy equipment

TC 62/SC 62D

57. ISO 80601-2-84 ED1

Medical electrical equipment - Part 2-84:

Particular requirements for the basic

safety and essential performance of

ventilators for the emergency medical

services environment (EMS)

TC 62/SC 62D


58. ISO 80601-2-69 ED2

Medical electrical equipment - Part 2-69:

Particular requirements for basic safety

and essential performance of oxygen

concentrator equipment

AFDIS

TC 62/SC 62D

59. ISO/IEC 30161 ED1 Internet of Things (IoT) - Requirements

of IoT data exchange platform for various

IoT services

ISO/IEC JTC 1/SC 41

60. ISO/IEC 19818-1 ED1 ISO 19818: Eye and face protection —

Protection against laser radiation —

Requirements and test methods

TC 76

61. IEC PAS 63312 ED1 Technical specification for flame detector

system of boiler

TC 65/SC 65B

62. IEC 63288 ED1 Wireless Power Transfer - Measuring

method for wireless power transfer

efficiency and standby power - mobile

phone (TA 15)

TC 100/TA 15

63. IEC 63270 ED1 Industrial automation equipment and

systems - Predictive maintenance

TC 65/SC 65E

64. IEC 63252 ED1 Energy consumption of vending machines TC 59

65. IEC TR 63250 ED1 Household electrical appliances - Method

of measuring performance - Assessment

of repeatability, reproducibility and

uncertainty

TC 59

66. IEC SRD 63235 ED1 Systems Reference Deliverable (SRD) -

Smart City System - Methodology for

concepts building

SyC Smart Cities

67. IEC TS 63199 ED1 Top priority standards development

status in the domain of smart energy

SyC Smart Energy

68. IEC 63193 ED1 Lead-acid batteries for propulsion power

of lightweight vehicles – General

requirements and methods of test

TC 21

69. IEC/IEEE 63160 ED1

Nuclear facilities – Instrumentation,

control and electrical power systems

important to safety - Common cause

failure, system analysis and diversity

TC 45/SC 45A

70. IEC 63148 ED1 Requirements of tracking system for

radioactive materials

TC 45

71. IEC 63117 ED1

General requirements for lighting systems

- Safety

CDM

TC 34

72. IEC/IEEE 63113 ED1 Nuclear facilities - Instrumentation

important to safety - Spent fuel pool

instrumentation

TC 45/SC 45A

73. IEC 62890 ED1 Industrial-process measurement, control

and automation -- Life-cycle-management

for systems and components

TC 65

74. IEC 62840-1 ED1 Electric vehicle battery swap system -

Part 1: General and guidance

TC 69

75. IEC 62793 ED2 Protection against lightning -

Thunderstorm warning systems

TC 81

76. IEC 62682 ED2 Management of alarms systems for the TC 65/SC 65A


process industries

77. IEC 62471-6 ED1 Photobiological Safety of Ultraviolet

Lamp Products

TC 76

78. IEC TR 62222 ED3 Fire performance of communication

cables installed in buildings

TC 46/SC 46C

79. IEC 62040-1/AMD1

ED2

Uninterruptible power systems (UPS) -

Part 1: Safety requirements

TC 22/SC 22H

IEC 61643-01 ED1 Low-voltage surge protective devices -

Part 01: General Requirements and test

methods

TC 37/SC 37A

80. IEC 61400-1/FRAGF

ED4

Wind energy generation systems - Part 1:

Design requirements

TC 88

81. IEC 61098 ED3 Radiation protection instrumentation -

Installed personnel surface contamination

monitoring assemblies

TC 45/SC 45B

82. IEC 61010-2-130 ED1

Safety requirements for electrical

equipment for measurement, control, and

laboratory use - Particular requirements

for equipment intended to be used in

educational establishments by children

TC 66

83. IEC 61007 ED3 Transformers and inductors for use in

electronic and telecommunication

equipment - Measuring methods and test

procedures

TC 51

84. IEC/IEEE 60980-344

ED1

Nuclear facilities - Equipment important

to safety - Seismic qualification

TC 45/SC 45A

85. IEC 60809/FRAG1

ED4

Fragment 1 - Lamps for road vehicles -

Dimensional, electrical and luminous

requirements

TC 34/SC 34A

86. IEC 60691 ED5 Thermal-links - Requirements and

application guide

TC 32/SC 32C

87. IEC 60545 ED2

Guideline for commissioning and

operation of hydraulic turbines, pump-

turbines and storage pumps

TC 4

88. IEC 60268-22 ED1

Sound system equipment - Electrical and

mechanical measurements (TA 20)

TC 100/TA 20

***

South Asian Regional Standards Organization (SARSO) Secretariat 116/A, Tejgaon Industrial Area, Dhaka-1208, Bangladesh

Tel: +88 02 8878130, Fax: +88 02 8878131 E-mail: [email protected]; Website: www.sarso.org

tel:+88%2002%208878130

http://www.sarso.org/


Report on National Standards of SAARC Member States and

International Standards

To

Help in the Fight against Corona Virus Disease 2019 (COVID- 19) Crisis in

SAARC region

1. INTRODUCTION

In these troubled times when the entire Nations are living in an uncertain period with the attack

spread of the Corona Virus Disease 2019 (COVID-19) and with no specific cure in sight, the South

Asian Regional Standards Organization (SARSO) desiring to perform its role of disseminating

information on the published National Standards of SAARC Member States and the International

Standards on Preventive tools to assist fight against COVID 19, has made a humble effort.

Experts from the Member States of SAARC and the International Standards Community have toiled

tirelessly over the years to develop Standards on diverse subjects. A cursory scan of these huge

repository of Standards have revealed quite a number of Standards that can be used by SAARC

Member States to prevent the further onslaught of the Pandemic. The result of this scan is the

following list of Standards. However, it is humbly requested that it may not be construed that the list

is by any means exhaustive. Any omissions or errors may kindly be excused.

In case any addition or correction is proposed by any Member Body would be acted upon by SARSO

Secretariat, such that this list serves as a permanent reference point in the SARSO website.


2. ABOUT SARSO

The South Asian Regional Standards Organization (SARSO), a SAARC Specialized Body of SAARC

was established after the SAARC Agreement on the Establishment of South Asian Regional Standards

Organization (SARSO) entered into force with effect from 25 August 2011 after ratification by all

member States of SAARC. The SARSO Headquarters commenced its operations in Dhaka,

Bangladesh with effect from 03 April 2014. The SARSO has been established to achieve and enhance

coordination and cooperation among SAARC member countries in the fields of standardization and

conformity assessment and is aimed to develop harmonized standards for the region to facilitate

intra-regional trade and to have access in the global market.

3. SCOPE AND BACKGROUND OF THE WORK

Among the various objectives and functions of SARSO, one is to act as a source of information for

the Member States on standards, regulations, conformity assessment.

In view of the rapidly spreading coronavirus disease 2019 (COVID-19) pandemic, SARSO has compiled the list

of important National Standards published by SAARC Member States and published International Standards so

that it can be used in the SAARC region as the source of information of very important standards for

government agencies, researchers, laboratories, consumers and manufacturers of medical equipment

and protective products

4. METHODOLOGY

This work of identifying the list of the very important standards of SAARC member States and

International Standards is based on information available in the websites of the respective standards

bodies.


5. NATIONAL STANDARDS OF SAARC MEMBER STATES

I. AFGHANISTAN

Sl. No. National Standards with Designation and Title

1 AS 126 Standard for Liquid Toilet Soap-Specification

2 AS 272 Standard specification for Rubber Surgical Gloves

3 AS 273 Standard specification for poly vinyl chloride (PVC) Gloves for

Medical Application

4 AS 315 Standard Test methods for detection of holes in medical gloves

5 AS 320 Standard Test methods for residual powder on medical gloves

6 AS 450 Standard of Sterile hypodermic syringes for Single use -Part 1:

Syringes for manual use

7 AS 484 Standard of Oxygen for medical use - specification and test methods

8 AS 485 Standard for Injection equipment for medical use - Part 1: ampouls

for injectable

9 AS 486 Standard of Plastic containers for intravenous injection

10 AS 488 Standard of laundry powder soap

11 AS 492 Standard of Transfusion equipment for medical use part 3: blood –

taking set

12 AS 585 Standard Specification for waste water and emission of biomedical

waste

13 AS 601 Standard for cotton of medical and sanitary use

14 AS 619 Standard of Disposable plastic syringes for medical use, test of

integration between syringe and pharmaceutical preparation

15 AS 636 The National Standard of Liquid Disinfectant soap for medical use

16 AS ISO 15189 Standard for Medical laboratories–Requirements for quality

and competence

17 AS ISO 22367 The National Standard for Medical laboratories–Reduction of

error through risk management and continual improvement


II. BANGLADESH


1 BDS 12:1991 Laundry soap (Second Revision, Reaffirmed 2014)

2 BDS 13:2006 Toilet soap (Third Revision ; Amendment 1, 2008)

3 BDS 181:2001 Carbolic soap

4 BDS 188:1992 Soap flakes (First Revision)

5 BDS 237:1963 Surgical instruments and appliances Covers general

requirements regarding quality of material and finished products,

construction, sampling, tests etc.

6 BDS 406: 2016 Methods of Sampling and Test for Soaps (Second Revision)

7 BDS 751:1969 Moulded rubber hot water bottle for hospital use.

8 BDS 764:1970 Horizontal rectangular hospital sterilizer pressure steam type

9 BDS 1740:2004 Liquid toilet soap

10 BDS 1536: 2016 Glycerine Toilet Soap (First Revision)

11 BDS 1798:2008 Baby toilet soap

12 BDS : 1908 2016 Transparent toilet soap

13

BDS ISO 32:2008 Gas cylinders for medical use- Marking for identification

of content

14 BDS ISO 10282:2003 Specifications for Single- use Sterile Rubber Surgical

Gloves

15 BDS ISO 15189:2012 Medical laboratories- Particular requirements for

quality and competence

***


III. BHUTAN


1 BTS 56:2018 IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2:

General requirements for basic safety and essential performance - Collateral

Standard: Electromagnetic disturbances - Requirements and tests

2 BTS 57:2018 IEC 60601-1-3:2008 (Including amd.1) Medical electrical

equipment - Part 1-3: General requirements for basic safety and essential

performance - Collateral Standard: Radiation protection in diagnostic X-ray

equipment

3 BTS 58:2018 IEC 60601-1-8:2006 (Including amd. 1) Medical electrical

equipment - Part 1-8: General requirements for basic safety and essential

performance - Collateral Standard: General requirements, tests and

guidance for alarm systems in medical electrical equipment and medical

electrical systems

4 BTS 59:2018 IEC 60601-1-11:2015 Medical electrical equipment – Part 1-

11: General requirements for basic safety and essential performance –

Collateral Standard: Requirements for medical electrical equipment and

medical electrical systems used in the home healthcare environment


General requirements for basic safety and essential performance - Collateral

Standard: Requirements for medical electrical equipment and medical

electrical systems intended for use in the emergency medical services

environment

6 BTS 90:2018 IEC 60601-2-43:2010 (including amd.1) Medical electrical

equipment - Part 2-43: Particular requirements for the basic safety and

essential performance of X-ray equipment for interventional procedures


Particular requirements for the basic safety and essential performance of

multifunction patient monitoring equipment

8 BTS 97:2018 IEC 60601-2-52:2009 (including amd.1) Medical electrical

equipment - Part 2-52: Particular requirements for the basic safety and

essential performance of medical beds

9 BTS 98:2018 IEC 60601-2-54:2009 (including amd.1)Medical electrical

equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

10 BTS 109:2018 ISO 80601-2-56:2017 Medical electrical equipment - Part 2-

56: Particular requirements for basic safety and essential performance of

clinical thermometers for body temperature measurement

11 BTS 110:2018 ISO 80601-2-61:2017 Medical electrical equipment -- Part 2-

61: Particular requirements for basic safety and essential performance of

pulse oximeter equipment


IV INDIA


1. IS 17334 Medical Textiles —Surgical Gowns and Surgical Drapes —

Specification

2. IS 3055 : Part 1 : 1994 Clinical thermometers: Part 1 solid stem type -

Specification (Second Revision)

3. IS 3055 : Part 2 : 2004 Clinical thermometers: Part 2 enclosed scale type -

Specification (Third Revision)

4. IS 3119 : 1978 Specification for hot air sterilizers (First Revision)

5. IS 3235 : 1988 General requirements for syringes for medical use (Second

Revision)

6. IS 3236 : 1992 Hypodermic syringes for general purposes - Specification

(Second Revision)

7. IS 3237 : Part 4 : 1986 Specification for special purpose syringes: Part 4

vaccine syringe

8. IS 3740 : 1966 Specification for tubes, glass, for pathological work

9. IS 3829 : Part 1 : 1999 Specification for steam sterilizers: Part 1 horizontal

cylindrical and horizontal rectangular steam sterilizers, pressure type (For

Hospital And Pharmaceutical Use) (Second Revision)

10. IS 3829 : Part 2 : 1978 Specification for steam sterilizers: Part 2 horizontal

cylindrical high speed steam sterilizers, pressure type (First Revision)

11. IS 3829 : Part 3 : 1985 Specification for steam sterilizers: Part 3 pressure

sterilizers, vertical cylindrical type

12. IS 3992 : 1982 Specification for trays, kidney (First Revision)

13. IS 3993 : 1993 Trays, instruments - Specification (Second Revision)

14. IS 3994 : 1993 Bowls,wash - Specification (Second Revision)

15. IS 4033 : 1968 General requirements for hospital furniture

16. IS 4035 : 1967 Specification for trolleys, stretcher

17. IS 4036 : 1967 Specification for trolleys, patient

18. IS 4037 : 1967 Specification for stretchers and stretcher carriers

19. IS 4148 : 1989 Surgical rubber gloves - Specification (First Revision)

20. IS 4266 : 1967 Specification for lockers, bedside for hospital use

21. IS 4381 : 1967 Specification for pathological microscope

22. IS 4458 : 1967 Specification for screens, bedside

23. IS 4787 : 1968 Specification for table, examination

24. IS 5022 : 1989 Sterilizer, instruments, table model (Third Revision)

25. IS/ISO 5367 : 2000 Breathing tubes intended for use with anaesthetic

apparatus and ventilators

26. IS 6207 : 1971 Specification for trolleys for oxygen cylinders

27. IS 7455 : 1974 Specification for sterilizer, pressure, hot and cold water

28. IS 7620 : Part 1 : 1986 Specification for diagnostic medical X-ray equipment: Part 1 general and safety requirements (First Revision)


29. IS 7620 : Part 2 : 1986 Specification for diagnostic medical X-ray equipment:

Part 2 performance requirements (First Revision)

30. IS 7620 : Part 3 : 1991 Medical electrical equipment - Diagnostic X-ray

equipments: Part 3 radiation safety requirements

31. IS 7652 : 1988 Specification for sphygmomanometer, aneroid type (First

Revision)

32. IS 9395 : 1979 Specification for bed, intensive care

33. IS 13115 : 1991 Portable first - Aid kit for general use - Specification

34. IS/ISO 10651 : Part 3 : 1997/ISO 10651-3 : 1997 Lung ventilators for medical

use: Part 3 particular requirements for emergency and transport ventilators


use - Particular requirements for basic safety and essential performance: Part

4 particular requirements for operator - Powered resuscitators

36. IS/ISO 10651: Part 5 : 2006/ISO 10651-5 : 2006 Lung ventilators for medical

use ? Particular requirements for basic safety and essential performance: Part

5 gas - Powered emergency resuscitators


use - Particular requirements for basic safety and essential performance: Part

6 home - Care ventilatory support devices

38. IS/ISO 11197 : 2016/ISO 11197 : 2016 Medical Supply unit

39. IS/ISO 5367 : 2000/ISO 5367: 2000 Breathing tubes intended for use with

anaesthic apparatus and ventillators

40. IS 1061 : 2017 Disinfectant fluids, phenolic type - Specification (Fifth Revision)

41. IS 10758 : 1983 Specification for de - Odourizing - Cum - Disinfectant fluids

42. IS 11479 : Part 1 : 2001 Antibacterial toilet soap - Specification: Part 1 solid

cake (First Revision)

43. IS 11479 : Part 2 : 2001 Antibacterial toilet soap - Specification: Part 2 liquid

44. IS 2888 : 2004 Toilet soap - Specification (Third Revision)

45. IS 4199 : 2001 Toilet soap, liquid - Specification (Third Revision)

46. IS 16548 : 2016/ISO 22612 : 2005 Clothing for protection against infectious

agents - Test method for resistance to dry microbial penetration

47. IS 16549 : 2016/ISO 22610 : 2006 Surgical drapes, gowns and clean air suits,

used as medical devices, for patients, clinical staff and equipment - Test

method to determine the resistance to wet bacterial penetration

48. !S 15113:2002 Clinical electrical thermometers with maximum device -

Specification

49. IS 80601 : Part 2 : Sec 56 : 2017 Medical electrical equipment: Part 2 particular

requirements for basic safety and essential performance: Sec 56 clinical

thermometers for body temperature measurement

50. IS 14166:1994 Respiratory protective devices full - Face masks - Specification

51. IS 16288: 2014 Medical textiles - Method for evaluation of the bacterial filtration

efficiency of surgical face masks

52. IS 16289: 2014 Medical textiles - Surgical face masks - Specification

53. IS 11363: 1985 Tubes ,breathing, for anaesthetic apparatus and ventilators


V. MALDIVES

Member State, Maldives does not have a National Standards Body.

***


VI. NEPAL


1 NS 4:2036 Toilet Soap

2 NS 7:2036 Laundry Soap Second Amendment

3 NS 30:2040 Powder soap

4 NS 164:2045 Carbolic soap

5 NS/ISO 15189:2003/2068 Medical laboratories -particular requirements for

quality and competence.

6 NS/ISO 7864:1993:2063 Sterile hypodermic needle for single use

7 NS/ISO 7886 - 1:1993:2063 Sterile hypodermic syringe for single use

Part 1: Syringes for manual use

***


VII. PAKISTAN


1 PS: 5255-2013 Pakistan Standards Terms and Definitions on Healthcare

2 PS: 5256-2013 Pakistan Standards Primary Healthcare Facilities

3 PS: 5257-2013 Pakistan Standards Hospital Standards

4 PS: 12-1978Laundry Soap (1st Revision).

5 PS: 13-2009Toilet Soap (2nd Revision).

6 PS: 188-1962Soap Flakes.

7 PS: 329-1963Soap Powder.

8 PS: 698-1968 Surgical Rubber Gloves

9 PS: 709-1980Liquid Toilet Soap (1st Revision).

10 PS: 764-1968 Horizontal rectangular hospital sterilizer pressure steam type.

11 PS: 1370-1975 Transfusion equipment for medical use

12 PS:3790-2-46/2000 Medical electrical equipment-

Part-2-46: Particular requirements for the safety of operating tables.

(Based on IEC-601-2-46/1998

13

PS:4234-2014 Guidelines for administrative, medical, and nursing staff

concerned with the safe use of medical electrical equipment and medical

electrical systems.

(1st Revision) (Based on IEC TR 60930/2008)

14 PS: 4274-1998 General requirements for protective clothing.

15 PS: 4397/1999Single use Sterile Surgical Gloves.

16 PS: 4866/1-2008 Sterile hypodermic syringes for single use. Part-1: Syringes

for manual use

17 PS: 5168/1-2010 Antibacterial Toilet Soap Solid Cake

18 PS: 5168/2-2010 Antibacterial Toilet Soap Liquid

***


VIII. SRI LANKA


1 SLS ISO 22320 Societal security – emergency management – requirements

for incident response

2 SLS 34 Toilet soap

3 SLS 35 Carbolic soap

4 SLS 37 Soft soaps

5 SLS 38 Laundry soap powders, flakes and chips

6 SLS 250 Liquid soap

7 SLS 359 Surgical rubber gloves

8 SLS 440 Carbolic soap manufactured entirely from coconut oil

9 SLS 441 Laundry soap powder, flakes and chips manufactured entirely from

coconut oil

10 SLS 442 Toilet soap manufactured entirely from coconut oil

11 SLS 443 Laundry soaps (pure and built) manufactured entirely from

coconut oil

12 SLS 547 Baby soap

13 SLS 554 Laundry soap

14 SLS 688 Disinfectants

15 SLS 1142 Liquid toilet soap

16 SLS 1390 Liquid soap for domestic and industrial purposes

17 SLS 1626 Single-use sterile rubber surgical gloves

18 SLS ISO 15189 Medical laboratories – requirements for quality and

competence

19 SLS ISO 31000 Risk management – guidelines

20 LS IEC/ISO 31010 Risk management – risk assessment techniques

***


6. INTERNATIONAL STANDARDS

I. INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)

Sl. No. ISO Standards with Designation and Title

1. ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-

organisms - Part 5: Terminology and performance requirements for micro-

organisms risks

2. ISO 10651-3:1997 Lung ventilators for medical use — Part 3: Particular

requirements for emergency and transport ventilators

3. ISO 10651-4:2002 Lung ventilators — Part 4: Particular requirements for

operator-powered resuscitators

4. ISO 10651-5:2006 Lung ventilators for medical use — Particular

requirements for basic safety and essential performance — Part 5: Gas-

powered emergency resuscitators

5. ISO 10993-1:2018 Biological evaluation of medical devices - Part 1:

Evaluation and testing within a risk management process

6. ISO/TR 13154:2017 Medical electrical equipment — Deployment,

implementation and operational guidelines for identifying febrile humans

using a screening thermograph

7. ISO 13485:2016, Medical devices — Quality management systems -

Requirements for regulatory purposes

8. ISO 13688:2013 Protective clothing - General requirements

9. ISO/TS 16976-8:2013, Respiratory protective devices — Human factors —

Part 8: Ergonomic factors

10. ISO 17510:2015 Medical devices — Sleep apnoea breathing therapy —

Masks and application accessories

11. ISO 18082:2014, Anaesthetic and respiratory equipment — Dimensions of

non-interchangeable screw-threaded (NIST) low-pressure connectors for

medical gases [Including ISO 18082:2014/AMD 1:2017, AMENDMENT 1]

12. ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in

healthcare applications — Part 1: Evaluation and testing within a risk

management process


healthcare applications — Part 2: Tests for emissions of particulate matter


healthcare applications — Part 3: Tests for emissions of volatile organic

compounds (VOCs)


healthcare applications — Part 4: Tests for leachables in condensate

16. ISO 18778:2005 Respiratory equipment — Infant monitors — Particular

requirements

17. ISO 19223:2019, Lung ventilators and related equipment — Vocabulary and

semantics

18. ISO 20395:2019, Biotechnology — Requirements for evaluating the

performance of quantification methods for nucleic acid target sequences —

qPCR and dPCR


19. ISO 20789:2018 Anaesthetic and respiratory equipment — Passive

humidifiers

20. ISO/TR 21954:2018 Guidance on the selection of the appropriate means of

ventilation based on the intended patient, use environment, and operator

21. ISO 22301:2019 Security and resilience - Business continuity management

systems – Requirements

22. ISO 22316:2017 Security and resilience - Organizational resilience -

Principles and attributes

23. ISO 22395:2018 Security and resilience - Community resilience - Guidelines

for supporting vulnerable persons in an emergency

24. ISO 22320:2018 Security and resilience - Emergency management -

Guidelines for incident management

25. ISO 23747:2015 Anesthetic and respiratory equipment — Peak expiratory

flow meters for the assessment of pulmonary function in spontaneously

breathing humans

26. ISO 26782:2009 Anesthetic and respiratory equipment — Spirometers

intended for the measurement of time forced expired volumes in humans

(with Corrigendum 1)

27. ISO 31000:2018 Risk management – Guidelines

28. ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical

connectors — Part 1: Cones and sockets

29. ISO 80601-2-12:2020, Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care

ventilators

30. ISO 80601-2-13:2011, Medical electrical equipment — Part 2-13: Particular

requirements for basic safety and essential performance of an anaesthetic

workstation [Including: ISO 80601-2-13:2011/Amd.1:2015, AMENDMENT 1 and ISO 80601-2-13:2011/Amd.2:2018, AMENDMENT 2]

31. ISO 80601-2-56:2017 Medical electrical equipment — Part 2-56: Particular

requirements for basic safety and essential performance of clinical

thermometers for body temperature measurement (With Amendment 1)


requirements for basic safety and essential performance of pulse oximeter

equipment


requirements for basic safety and essential performance of oxygen-

conserving equipment


requirements for basic safety and essential performance of oxygen

concentrator equipment


requirements for basic safety and essential performance of sleep apnoea

breathing therapy equipment


requirements for basic safety and essential performance of home healthcare

environment ventilators for ventilator-dependent patients



requirements for basic safety and essential performance of respiratory

humidifying equipment


requirements for basic safety and essential performance of ventilatory

support equipment for ventilatory impairment


requirements for basic safety and essential performance of ventilatory

support equipment for ventilatory insufficiency

40. ISO 81060-1:2007 Non-invasive sphygmomanometers — Part 1:

Requirements and test methods for non-automated measurement type

41. ISO 81060-2:2018 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type (With

Amendment 1)

42. ISO/TS 81060-5:2020 Non-invasive sphygmomanometers — Part 5:

Requirements for the repeatability and reproducibility of NIBP simulators

for testing of automated non-invasive sphygmomanometers

***


II. INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC)

Sl. No. IEC Standards with Designation and Title

1 IEC 60601-1:2005 CSV Medical electrical equipment - Part 1: General

requirements for basic safety and essential performance (With Amendment

1)

2 IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General

requirements for basic safety and essential performance - Collateral

standard: Electromagnetic disturbances - Requirements and tests



standard: Usability

4 IEC 60601-1-8:2006, Medical electrical equipment — Part 1-8: General

requirements for basic safety and essential performance — Collateral

standard: General requirements, tests and guidance for alarm systems in

medical electrical equipment and medical electrical systems



Standard: Requirements for medical electrical equipment and medical

electrical systems used in the home healthcare environment

6 IEC 60601-1-10:2007 Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral

standard: Requirements for the development of physiologic closed-loop

controllers

7 IEC 60601-1-12:2015 Medical Electrical Equipment — Part 1-12: General

requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical

electrical systems used in the emergency medical services environment

8 IEC 60601-1-10:2007 Medical electrical equipment — Part 1-10: General

requirements for basic safety and essential performance — Collateral

standard: Requirements for the development of physiologic closed-loop controllers (With Amendment 1)

9 IEC 80601-2-26:2019 Medical electrical equipment — Part 2-26: Particular

requirements for the basic safety and essential performance of

electroencephalographs

10 IEC 60601-1-8:2006/AMD 1:2012 Medical electrical equipment — Part 1-8:

General requirements for basic safety and essential performance —

Collateral standard: General requirements, tests and guidance for alarm

systems in medical electrical equipment and medical electrical systems

(With Amendment 1)


requirements for the basic safety and essential performance of

multifunction patient monitoring equipment


requirements for the basic safety and essential performance of functional

Near-Infrared Spectroscopy (NIRS) equipment

13

IEC 80601-2-30:2018 Medical electrical equipment — Part 2-30: Particular

requirements for basic safety and essential performance of automated non-


invasive sphygmomanometers

14 IEC 80601-2-59:2017Medical electrical equipment — Part 2-59: Particular

requirements for the basic safety and essential performance of screening

thermographs for human febrile temperature screening

7. REFERENCES

Afghanistan National Standards Authority (ANSA)

https://ansa.gov.af/en

Bangladesh Standards and Testing Institution (BSTI)

http://www.bsti.gov.bd/

Bhutan Standards Bureau (BSB)

http://www.bsb.gov.bt/

Bureau of Indian Standards (BIS)

https://bis.gov.in/

Maldives Standards and Metrology Unit

http://www.standards.gov.mv/

Nepal Bureau of Standards & Metrology (NBSM)

http://nbsm.gov.np/index.php

Pakistan Standards and Quality Control Authority (PSQCA)

http://updated.psqca.com.pk/

Sri Lanka Standards Institution (SLSI)

http://www.slsi.lk/index.php?lang=en

International Organization for Standardization (ISO)

https://www.iso.org/home.html

International Electrotechnical Commission (IEC)

https://www.iec.ch/

***

https://ansa.gov.af/en

http://www.bsti.gov.bd/

http://www.bsb.gov.bt/

https://bis.gov.in/

http://www.standards.gov.mv/

http://nbsm.gov.np/index.php

http://updated.psqca.com.pk/

http://www.slsi.lk/index.php?lang=en

https://www.iso.org/home.html

https://www.iec.ch/

Newsletter of the South Asian Regional Standards Organization

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Transcript of Newsletter of the South Asian Regional Standards Organization