Programme of work

BUREAU OF INDIAN STANDARDS

Medical Equipment and Hospital Planning Department

Programme of Work

MHD11 : Anesthetic, Resuscitation and Allied Equipment

Scope : To formulate Indian Standards for instruments and equipment used for anaesthesing and ventilating a patient, including diagnostic instruments such as sphygmomanometers, suction apparatus and anaesthetic face mask.
Liaison :

ISO/TC 121 - Anaesthetic and respiratory equipment - Participating (P)
ISO/TC 121/SC 1 - Breathing attachments and anaesthetic machines - Participating (P)
ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care - Participating (P)
ISO/TC 121/SC 4 - Vocabulary and semantics - Participating (P)
ISO/TC 121/SC 2 - Airway devices and related equipment - Participating (P)
ISO/TC 121/SC 6 - Medical gas supply systems - Participating (P)
ISO/TC 121/SC 8 - Suction devices - Participating (P)
ISO TC 121/SC 1/WG 9 - Anaesthetic systems
ISO TC 121/SC 2/WG 11 - Oxygen therapy devices
ISO TC 121/SC 2/WG 13 - Airway tubes and connectors
ISO TC 121/SC 2/WG 17 - Laryngoscopes
ISO/TC 121/SC 3/JWG 1 - Joint ISO/TC 121/SC 3-IEC/SC 62D WG : Critical care ventilators
ISO/TC 121/SC 3/JWG 11 - Joint ISO/TC 121/SC 1 and SC 3-IEC/SC 62A WG: Emergency medical services equipment
ISO/TC 121/SC 3/JWG 12 - Joint ISO/TC 121/SC 3-IEC/SC 62D WG: Home respiratory equipment
ISO/TC 121/SC 3/JWG 14 - Joint ISO/TC 121/SC 3-IEC/SC 62D WG: Electromedical diagnostic and patient monitoring equipment
ISO/TC 121/SC 3/JWG 6 - Joint ISO/TC121/SC 3 - IEC/SC/62A JWG 6: Medical electrical equipment and medical electrical systems used in home care application
ISO TC 121/SC 3/WG 13 - Biocompatibility of respiratory gas pathways
ISO TC 121/SC 4/WG 1 - Respiratory equipment vocabulary
ISO TC 121/SC 4/WG 3 - Respiratory care equipment
ISO TC 121/SC 6/WG 4 - Medical gas pipeline systems
ISO TC 121/SC 6/WG 6 - Medical Supply Units
ISO TC 121/WG 1 - Connectors for respiratory therapy devices and accessories
ISO TC 121/WG 3 - Cybersecurity for anaesthetic and respiratory equipment

Published Standards

SI. No.	IS No.	Title	Reaffirmation Details	No. of Amendments	Degree of Equivalence
1.	IS/ISO 10524-3 : 2019 ISO 10524-2:2019 Reviewed In : 2024	Pressure regulators for use with medical gases- Part 3: Pressure regulators integrated with cylinder valves VIPRs First Revision	March, 2024	-	Identical under single numbering
2.	IS/ISO 10524-4 : 2008 ISO 10524 -4 :2008 Reviewed In : 2024	Pressure regulators for use with medical gases: Part 4 low - Pressure regulators	August, 2024	-	Identical under single numbering
3.	IS/ISO 18697-4 : 2024	Lung Ventilators Part 4 Particular Requirements for Userâ€“ Powered Resuscitators (ISO 10651-4 : 2023, MOD) (First Revision)		-	Modified/Technically Equivalent
4.	IS/ISO 10651-4 : 2002 ISO 10651-4 : 2002 Reviewed In : 2023	Lung ventilators for medical use - Particular requirements for basic safety and essential performance: Part 4 particular requirements for operator - Powered resuscitators	January, 2023	-	Modified/Technically Equivalent
5.	IS/ISO 10651-5 : 2006 ISO 10651-5 : 2006 Reviewed In : 2023	Lung ventilators for medical use - Particular requirements for basic safety and essential performance: Part 5 gas - Powered emergency resuscitators	March, 2023	-	Identical under single numbering
6.	IS/ISO 11197 : 2019 ISO 11197:2019 Reviewed In : 2024	Medical Supply Units First Revision	March, 2024	-	Identical under single numbering
7.	IS 11378 : 2002 ISO 5358 Reviewed In : 2017	Anaesthetic machines for use with humans (First Revision)	March, 2017	-	Identical under dual numbering
8.	IS/ISO 11712 : 2009 ISO 11712 : 2009 Reviewed In : 2019	Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors	November, 2019	-	Identical under single numbering
9.	IS 12417 : 1988 Reviewed In : 2019	Specification for suction apparatus, pedal operated	January, 2019	1	Indigenous
10.	IS 13200 : 2023 ISO 4135:2022	Anaesthetic and Respiratory Equipment Vocabulary Second Revision		-	Identical under dual numbering
11.	IS 13450 (Part 2/Sec 12) : 2023 ISO 80601-2-12:2020	Medical Electrical Equipment Part 2 Particular requirements for basic safety and essential performance Section 12 Critical care ventilators (First Revision)		-	Identical under dual numbering
12.	IS 13450 (Part 2/Sec 13) : 2024	Medical Electrical Equipment: Part 2 Particular Requirements for the Basic Safety and Essential Performance: Sec 13 Anaesthetic Workstation (First Revision)		-	Modified/Technically Equivalent
13.	IS 13450 (Part 2/Sec 70) : 2022 ISO 80601-2-70:2020	Medical electrical equipment Part 2 - Particular requirements for basic safety and essential performance Section 70 : Sleep apnoea breathing therapy equipment		-	Identical under dual numbering
14.	IS 13450 (Part 2/Sec 79) : 2023 ISO 80601-2-79:2018	Medical electrical equipment Part 2 - Particular requirements for basic safety and essential performance Section 79 - Ventilatory support equipment for ventilatory impairment		-	Identical under single numbering
15.	IS 13450 (Part 2/Sec 80) : 2023 ISO 80601-2-80:2018	Medical electrical equipment Part 2 - Particular requirements for basic safety and essential performance Section 80 - Ventilatory support equipment for ventilatory insufficiency		-	Identical under single numbering
16.	IS 13450 (Part 2/Sec 84) : 2023 ISO 80601-2-84:2020	Medical electrical equipment Part 2 - Particular requirements for basic safety and essential performance Section 84 Ventilators for emergency medical services environment		-	Identical under dual numbering
17.	IS/ISO 14408 : 2005 ISO 14408 : 2005 Reviewed In : 2020	Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information	April, 2020	-	Identical under single numbering
18.	IS/ISO 15001 : 2010 Reviewed In : 2023	Anaesthetic and respiratory equipment - Compatibility with oxygen (First Revision)	January, 2023	-	Identical under single numbering
19.	IS/ISO 15002 : 2008 ISO15002:2008 Reviewed In : 2023	Flow - Metering devices for connection to terminal units of medical gas pipeline systems	January, 2023	-	Identical under single numbering
20.	IS/ISO 18467 : 2024 ISO 16628 : 2022	Anaesthetic and Respiratory Equipment â€” Tracheobronchial Tubes (First Revision)		-	Identical under dual numbering
21.	IS/ISO 16628 : 2008 ISO 16628 : 2008 Reviewed In : 2023	Tracheobronchial tubes - Sizing and marking	January, 2023	-	Identical under dual numbering
22.	IS 17426 : 2020	ICU Ventilators for use in COVID-19 - Specification		-	Indigenous
23.	IS 17587 : 2021	Specification for Pedal operated resuscitator		-	Indigenous
24.	IS 17625 (Part 2/Sec 69) : 2021 ISO 80601-2-69 : 2020	Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 69 Oxygen Concentrator Equipment		-	Identical under dual numbering
25.	IS 17812 (Part 1) : 2022 ISO 9170-1:2017	Terminal Units for Medical Gas Pipeline Systems : Part 1 Terminal Units for use with Compressed Medical Gases and Vacuum (First Revision)		-	Identical under dual numbering
26.	IS 18306 : 2023	Pneumatic Tourniquet- Specification		-	Indigenous
27.	IS 18360 : 2023 ISO 18082 : 2014	Anaesthetic and Respiratory Equipment Dimensions of Non-Interchangeable Screw-Threaded NIST Low-Pressure Connectors for Medical Gases		-	Identical under dual numbering
28.	IS 18361 (Part 1) : 2023	Pressure Regulators for use with Medical Gases : Part 1 Pressure Regulators and Pressure Regulators with Flow-Metering Devices first revision		-	Modified/Technically Equivalent
29.	IS 18361 (Part 2) : 2023 ISO 10524-2 : 2018	Pressure Regulators for use with Medical Gases Part 2 Manifold and line pressure regulators (First Revision)		-	Identical under dual numbering
30.	IS 18375 (Part 1) : 2023	Medical Suction Equipment Part 1 Electrically Powered Suction Equipment		-	Modified/Technically Equivalent
31.	IS 18375 (Part 2) : 2023 ISO 10079-2:2022	Medical Suction Equipment Part 2 Manually Powered Suction Equipment (Second Revision)		-	Identical under dual numbering
32.	IS 18375 (Part 3) : 2023 ISO 10079-3:2022	Medical Suction Equipment Part 3 Suction Equipment Powered from a Vacuum or Positive pressure Gas Source (Second Revision)		-	Identical under dual numbering
33.	IS 18377 : 2024 ISO 5366:2016	Anaesthetic and Respiratory Equipment Tracheostomy Tubes and Connectors		-	Identical under dual numbering
34.	IS 18460 : 2024 ISO 8836:2019	Suction Catheters for Use in the Respiratory Tract		-	Identical under dual numbering
35.	IS 18691 : 2024 ISO 5367 : 2023	Anaesthetic and Respiratory Equipment-Breathing Sets and Connectors		-	Identical under dual numbering
36.	IS 18696 : 2024	Anaesthetic and Respiratory Equipment- Oropharyngeal Airways		-	Modified/Technically Equivalent
37.	IS 18766 (Part 2) : 2024 ISO 18562-2:2024	Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications Part 2: Tests for Emissions of Particulate Matter		-	Identical under dual numbering
38.	IS 18772 (Part 2/Sec 87) : 2024	Medical electrical equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 87 High Frequency Ventilators		-	Modified/Technically Equivalent
39.	IS 18784 : 2024	Medical Devices ï¿½ Sleep Apnoea Breathing Therapy ï¿½ Masks and Application Accessories		-	Modified/Technically Equivalent
40.	IS 18785 : 2024	Anaesthetic and Respiratory Equipment ï¿½ Low-Flow Nasal Cannulae for Oxygen Therapy		-	Modified/Technically Equivalent
41.	IS 18805 : 2024 ISO 5359:2014	Anaesthetic and Respiratory Equipment Low-Pressure Hose Assemblies for Use with Medical Gases		-	Identical under dual numbering
42.	IS 18827 : 2024 ISO 5361:2023	Anaesthetic and respiratory equipment Tracheal tubes and connectors		-	Identical under dual numbering
43.	IS/ISO 26782 : 2009 ISO 26782:2009	Anaesthetic and respiratory equipment Spirometers intended for the measurement of time forced expired volumes in humans		-	Identical under single numbering
44.	IS/ISO 27427 : 2013 Reviewed In : 2021	Anaesthetic and Respiratory Equipment - Nebulizing Systems and Components	April, 2021	-	Identical under single numbering
45.	IS 3390 : 1988 Reviewed In : 2023	Specification for sphygmomanometers, mercurial (Second Revision)	January, 2023	1	Indigenous
46.	IS 3391 : 1965 Reviewed In : 2023	Specification for stethoscopes	January, 2023	-	Indigenous
47.	IS 3392 : 1965 Reviewed In : 2023	Specification for anaesthetic airways	January, 2023	-	Indigenous
48.	IS 3393 : 2024	Mouth Props and Airways (London Hospital Pattern) ï¿½ Specification (First Revision)		-	Indigenous
49.	IS 3393 : 1965 Reviewed In : 2023	Specification for mouth props and airways (London Hospital Pattern)	January, 2023	-	Indigenous
50.	IS 4113 : 2022 ISO 7376:2020	Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation		-	Identical under dual numbering
51.	IS 4154 : 1967 Reviewed In : 2024	Specification for endotracheal connections	August, 2024	-	Indigenous
52.	IS/ISO 5356-1 : 2015 ISO 5356-1 : 2015 Reviewed In : 2022	Anaesthetic and respiratory equipment - Conical connectors: Part 1 cones and sockets (First Revision)	March, 2022	-	Identical under single numbering
53.	IS/ISO 5356-2 : 2012 Reviewed In : 2020	Anaesthetic and respiratory equipment - Conical connectors: Part 2 screw - Threaded weight - Bearing connectors	August, 2020	-	Identical under single numbering
54.	IS/ISO 5361 : 1999 ISO 5361 : 1999 Reviewed In : 2022	Anaesthetic and respiratory equipment - Tracheal tubes and connectors	March, 2022	-	Identical under single numbering
55.	IS/ISO 5362 : 2006 ISO 5362 : 2006 Reviewed In : 2022	Anaesthetic reservoir bags	March, 2022	-	Identical under single numbering
56.	IS/ISO 5364 : 2008 ISO 5364:2008 Reviewed In : 2024	Anaesthetic and respiratory equipment - Oropharyngeal airways	July, 2024	-	Identical under single numbering
57.	IS/ISO 5366-1 : 2000 ISO 5366 Part 1 : 2000 Reviewed In : 2023	Anaesthetic and respiratory equipment - Tracheostomy tubes: Part 1 tubes and connectors for use in adults	January, 2023	-	Identical under single numbering
58.	IS/ISO 5367 : 2000 ISO 5367: 2000 Reviewed In : 2022	Breathing tubes intended for use with anaesthetic apparatus and ventilators	March, 2022	-	Identical under single numbering
59.	IS 5622 : 1970 Reviewed In : 2021	Soda-Lime Canisters for Use with Gas Anaesthetic Apparatus ( Waters' to-and-Fro)	February, 2021	-	Indigenous
60.	IS 5680 : 1969 Reviewed In : 2020	Specification for rubber tubing for medical use	January, 2020	1	Indigenous
61.	IS 6190 : 1971 Reviewed In : 2024	Specification for anaesthetic face masks	October, 2024	1	Indigenous
62.	IS 6194 : 1971 Reviewed In : 2021	Specification for intermittent positive pressure respirator, bag type, manually operated	February, 2021	-	Indigenous
63.	IS 6207 : 1971 Reviewed In : 2023	Specification for trolleys for oxygen cylinders	January, 2023	-	Indigenous
64.	IS 6581 : 1972 Reviewed In : 2024	Specification for endotracheal tubes (Rubber)	August, 2024	1	Indigenous
65.	IS 6807 : 1972 Reviewed In : 2024	Specification for Reinforced (Flexo-Metallic) Magill's Endotracheal Tube	August, 2024	-	Indigenous
66.	IS 7176 : 1985 Reviewed In : 2021	Specification for anaesthetic apparatus, drawover portable type (First Revision)	April, 2021	-	Indigenous
67.	IS 7176 : 2024	Drawover Portable Type Anaesthetic Apparatus â€” Specification (Second Revision)		-	Indigenous
68.	IS 18466 (Part 1) : 2024 ISO 7396-1:2016	Medical Gas Pipeline Systems Part 1: Pipeline Systems for Compressed Medical Gases and Vacuum (First Revision)		-	Identical under dual numbering
69.	IS/ISO 7396-2 : 2007 Reviewed In : 2019	Medcal gas pipelines systems: Part 2 gas scavenging disposal systems	June, 2019	-	Indigenous
70.	IS 7625 : 1975 Reviewed In : 2023	Gag, Mouth, Doyen's Pattern	January, 2023	1	Indigenous
71.	IS 7652 : 1988 Reviewed In : 2021	Specification for sphygmomanometer, aneroid type (First Revision)	February, 2021	-	Indigenous
72.	IS 7885 : 1985 Reviewed In : 2023	Spray, Macintosh's Pattern	January, 2023	-	Indigenous
73.	IS/IEC 80601-2-30 : 2018 IEC80601-2-30 : 2018 Reviewed In : 2024	Medical electrical equipment: Part 2 - 30 particular requirements for basic safety and essential performance of automated non - Invasive sphygmomanometers	August, 2024	-	Identical under single numbering
74.	IS/ISO 81060-1 : 2007 IEC81060_1 : 2007 Reviewed In : 2023	Non - Invasive sphygmomanometers: Part 1 requirements and test methods for non - Automated measurement type	January, 2023	-	Identical under single numbering
75.	IS/ISO 81060-2 : 2018 ISO 81060-2:2018	Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type		-	Identical under single numbering
76.	IS 8254 (Part 1) : 2024	Valve, Non-Rebreathing ï¿½ Specification Part 1 Rubenï¿½s Pattern (First Revision)		-	Indigenous
77.	IS 8254 (Part 1) : 1976 Reviewed In : 2023	Valve, Non-Rebreathing - Part I : Ruben's Pattern	January, 2023	-	Indigenous
78.	IS 8254 (Part 2) : 2024	Valve, Non-Rebreathing - Specification Part 2 Ambu-Hesse's Pattern ( First Revision )		-	Indigenous
79.	IS 8254 (Part 2) : 1976 Reviewed In : 2023	Specification for Valve, Non-Rebreathing Part 2 Ambu-Hesse's Pattern	January, 2023	-	Indigenous
80.	IS 8312 : 1977 Reviewed In : 2024	Forceps, Introducing, Endotracheal Tube, Magill's Pattern	October, 2024	1	Indigenous
81.	IS 8432 : 1977 Reviewed In : 2019	Specification for tubes, tracheostomy (Rubber Or Plastics)	April, 2019	1	Indigenous
82.	IS/ISO 9170-2 : 2008 ISO 9170 : Part 2 :2008 Reviewed In : 2022	Terminal units for medical gas pipeline systems: Part 2 terminal units for anaesthetic gas scavenging systems	March, 2022	-	Identical under single numbering
83.	IS 9462 : 1980 Reviewed In : 2023	Specification for humidifier, nebulizing, ventury type	January, 2023	-	Indigenous

Standards Under Develpoment

Projects Approved

SI. No.	Doc No	TITLE
1	MHD 11 (25367)	Systems for evacuation of plume generated by medical devices
2	MHD 11 (25368)	Anaesthetic vaporizers Agent specific filling systems
3	MHD 11 (25369)	Gas mixers for medical use Stand-alone gas mixers
4	MHD 11 (25370)	Inhalational anaesthesia systems Draw-over anaesthetic systems
5	MHD 11 (25384)	Anaesthetic and respiratory equipment Cuff pressure indication control and regulation devices
6	MHD 11 (25388)	Anaesthetic and respiratory equipment Air entrainment devices
7	MHD 11 (25392)	Respiratory equipment Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
8	MHD 11 (25393)	Respiratory equipment Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
9	MHD 11 (25396)	Anaesthetic and respiratory equipment Passive humidifiers
10	MHD 11 (25397)	Guidance on the selection of the appropriate means of ventilation based on the intended patient use environment and operator
11	MHD 11 (25398)	Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
12	MHD 11 (25399)	Anaesthetic and respiratory equipment Spirometers intended for the measurement of time forced expired volumes in humans
13	MHD 11 (26364) Revision of: IS 3390:1988	SPECIFICATION FOR SPHYGMOMANOMETERS MERCURIAL Third Revision
14	MHD 11 (26365) Revision of: IS 5680:1969	SPECIFICATION FOR RUBBER TUBING FOR MEDICAL USE First Revision
15	MHD 11 (26366) Revision of: IS 6190:1971	SPECIFICATION FOR ANAESTHETIC FACE MASKS First Revision
16	MHD 11 (26367) Revision of: IS 7625:1975	SPECIFICATION FOR GAG MOUTH DOYENS PATTERN First Revision

Preliminary Draft Standards

SI. No.	Doc No	TITLE
1	MHD 11 (26815)	Medical Grade Copper Tubes - Specification
2	MHD 11 (26817)	Particular Requirements for Basic Safety and Essential Performance of Bed Head Panels Gas Outlets and OT Pendants

Drafts Standards in WC Stage

SI. No.	Doc No	TITLE
No Records Found

Draft Standards Completed WC Stage

SI. No.	Doc No	TITLE
1	MHD 11 (25365)	Medical electrical equipment Part 2-67 Particular requirements for basic safety and essential performance of oxygen-conserving equipment
2	MHD 11 (25366)	Lung ventilators and related equipment Vocabulary and semantics
3	MHD 11 (25371)	Anaesthetic and respiratory equipment User-applied labels for syringes containing drugs used during anaesthesia Colours design and performance
4	MHD 11 (25372)	Medical electrical equipment Part 2-55 Particular requirements for the basic safety and essential performance of respiratory gas monitors
5	MHD 11 (25373)	Anaesthetic and respiratory equipment Heat and moisture exchangers HMEs for humidifying respired gases in humans Part 1 HMEs for use with minimum tidal volumes of 250 ml
6	MHD 11 (25374)	Anaesthetic and respiratory equipment Heat and moisture exchangers HMEs for humidifying respired gases in humans Part 2 HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
7	MHD 11 (25375)	Anaesthetic and respiratory equipment General requirements for airways and related equipment
8	MHD 11 (25381)	Breathing system filters for anaesthetic and respiratory use Part 1 Salt test method to assess filtration performance
9	MHD 11 (25383)	Breathing system filters for anaesthetic and respiratory use Part 2 Non-filtration aspects
10	MHD 11 (25389)	Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 3 Tests for emissions of volatile organic substances
11	MHD 11 (25390)	Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 4 Tests for leachables in condensate
12	MHD 11 (26320) Revision of: IS 3391:1965	SPECIFICATION FOR STETHOSCOPES FIRST REVISION
13	MHD 11 (26368) Revision of: IS 7885:1985	SPECIFICATION FOR MACINTOSH PATTERNS SPRAY SECOND REVISION
14	MHD 11 (26369) Revision of: IS 8312:1977	Specification for Forceps of Magill 39 s Pattern to place Endotracheal Tube First Revision

Finalized Draft Indian Standard

SI. No.	Doc No	TITLE
1	MHD 11 (25363)	Medical electrical equipment Part 2-72 Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
2	MHD 11 (25364)	Medical electrical equipment Part 2-74 Particular requirements for basic safety and essential performance of respiratory humidifying equipment

Finalized Draft Indian Standards under Print

SI. No.	Doc No	TITLE
1	MHD 11 (25205)	Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1 Evaluation and testing within a risk management process
2	MHD 11 (25228)	Medical Suction Equipment Part 4 General Requirements
3	MHD 11 (25299) Revision of: IS/ISO 11712:2009	Anaesthetic and respiratory equipment Supralaryngeal airways and connectors First Revision
4	MHD 11 (25362)	Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 90 Respiratory High-flow Therapy Equipment

Total Published Standards:62 Total Standards Under development : 38

Aspect Wise Report

Product:	69
Code of Practices :	3
Methods of Test :	3
Terminology :	1
Dimensions :	1
System Standard :	0
Safety Standard :	0
Others :	0
Service Specification :	0
Process Specification :	0
Unclassified :	0

Total :77

Annexure-I :List of Indian Standards Withdrawn/Superseded

SI. No.	IS No.	Title
1.	IS/ISO 10079-2 : 2014 ISO 10079-2: 2014 Reviewed In : 2023	Medical Suction Equipment Part 2 Manually Powered Suction Equipment First Revision
2.	IS/ISO 10079-3 : 2014 ISO 10079-3 : 2014 Reviewed In : 2023	Medical suction equipment Part 3 suction equipment powered from a vacuum or positive pressure gas source First Revision
3.	IS/ISO 10524-1 : 2006 ISO 10524-1:2006 Reviewed In : 2023	Pressure Regulators For Use with Medical Gases Part 1 Pressure Regulators and Pressure Regulators with Flow-Metering Devices
4.	IS/ISO 10524-2 : 2005 ISO10524-2:2005 Reviewed In : 2023	Pressure Regulators for use with Medical Gases Part 2 Manifold and Line Pressure Regulators
5.	IS/ISO 10651-3 : 1997 ISO 10651-3 : 1997 Reviewed In : 2023	Lung ventilators for medical use Part 3 particular requirements for emergency and transport ventilators
6.	IS/ISO 10651-6 : 2004 ISO 10651-6 : 2004 Reviewed In : 2023	Lung ventilators for medical use - Particular requirements for basic safety and essential performance Part 6 home - Care ventilatory support devices
7.	IS 11363 : 1985 ISO 5367 Reviewed In : 2011	Tubes breathing for anaesthetic apparatus and ventilators
8.	IS 11364 : 1994 ISO 5362 Reviewed In : 2010	Anaesthetic Reservoir Bags
9.	IS 11807 : 1994 ISO 5364 Reviewed In : 2010	Oropharyngeal Airways
10.	IS 11808 : 1986 ISO 7228 Reviewed In : 2011	Tracheal Tubes Connectors
11.	IS 12504 (Part 1) : 1988 ISO 5361-1 Reviewed In : 2009	Tracheal Tubes - Part 1 General Requirements
12.	IS 12504 (Part 2) : 1988 ISO 5361-2 Reviewed In : 2010	Tracheal Tubes - Part 2 Oro-tracheal and Naso-tracheal Tubes of the Magill Type Plain and Cuffed
13.	IS 12504 (Part 4) : 1988 Reviewed In : 2004	Specification for Tracheal Tubes - Part 4 Cole Type
14.	IS 12505 (Part 1) : 1988 ISO 5366-1 Reviewed In : 2010	Tracheostomy Tubes Part 1 Connectors
15.	IS 12505 (Part 2) : 1988 ISO 5366-2 Reviewed In : 2010	Tracheostomy Tubes Part 2 Basic Requirements
16.	IS 4113 (Part 1) : 2003 ISO 7376 : Part 1 Reviewed In : 2023	Laryngoscopic fittings Part 1 conventional hook - On type handle - Blade fittings Second Revision
17.	IS 4113 (Part 2) : 2003 ISO 7376 : Part 2 Reviewed In : 2023	Laryngoscopic fittings Part 2 miniature electric lamps - Screw threads and sockets for conventional blades Second Revision
18.	IS 4533 : 1995 Reviewed In : 2021	Suction apparatus - Specification Second Revision
19.	IS 5602 : 1970 Reviewed In : 2009	Specification for Anaesthetic Breathing Bags
20.	IS 7409 (Part 1) : 2003 ISO 5356-1 Reviewed In : 2009	Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1 Cones and Sockets
21.	IS 7409 (Part 2) : 1994 ISO 5356-2 Reviewed In : 2021	Anaesthetic and respiratory equipment - Conical connectors Part 2 screw - Threaded weight - Bearing connectors Second Revision
22.	IS/ISO 80601-2-13 : 2011 ISO 80601-2-13 : 2011 Reviewed In : 2023	Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 13 anaesthetic workstation
23.	IS/ISO 80601-2-12 : 2011 80601-2-12 : 2011 Reviewed In : 2023	Medical electrical equipment Part 2 - 12 particular requirements for basic safety and essential performance of critical care ventilators
24.	IS 8382 : 1977 Reviewed In : 2011	Pressure Regulators Pre-set Used with Medical Gas Cylinders
25.	IS/ISO 9170-1 : 2008 Reviewed In : 2021	Terminal units for medical gas pipeline systems Part 1 terminal units for use with compressed medical gases and vacuum

Annexure-II :List of Indian Product Standards

SI. No.	IS No. & Year	Title
1.	IS/ISO 10524-3 : 2019 ISO 10524-2:2019 Reviewed In : 2024	Pressure regulators for use with medical gases- Part 3 Pressure regulators integrated with cylinder valves VIPRs First Revision
2.	IS/ISO 10524-4 : 2008 ISO 10524 -4 :2008 Reviewed In : 2024	Pressure regulators for use with medical gases Part 4 low - Pressure regulators
3.	IS/ISO 18697-4 : 2024	Lung Ventilators Part 4 Particular Requirements for User Powered Resuscitators ISO 10651-4 2023 MOD First Revision
4.	IS/ISO 10651-5 : 2006 ISO 10651-5 : 2006 Reviewed In : 2023	Lung ventilators for medical use - Particular requirements for basic safety and essential performance Part 5 gas - Powered emergency resuscitators
5.	IS/ISO 11197 : 2019 ISO 11197:2019 Reviewed In : 2024	Medical Supply Units First Revision
6.	IS 11378 : 2002 ISO 5358 Reviewed In : 2017	Anaesthetic machines for use with humans First Revision
7.	IS/ISO 11712 : 2009 ISO 11712 : 2009 Reviewed In : 2019	Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
8.	IS 12417 : 1988 Reviewed In : 2019	Specification for suction apparatus pedal operated
9.	IS 13450 (Part 2/Sec 12) : 2023 ISO 80601-2-12:2020	Medical Electrical Equipment Part 2 Particular requirements for basic safety and essential performance Section 12 Critical care ventilators First Revision
10.	IS 13450 (Part 2/Sec 13) : 2024	Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Sec 13 Anaesthetic Workstation First Revision
11.	IS 13450 (Part 2/Sec 70) : 2022 ISO 80601-2-70:2020	Medical electrical equipment Part 2 - Particular requirements for basic safety and essential performance Section 70 Sleep apnoea breathing therapy equipment
12.	IS 13450 (Part 2/Sec 79) : 2023 ISO 80601-2-79:2018	Medical electrical equipment Part 2 - Particular requirements for basic safety and essential performance Section 79 - Ventilatory support equipment for ventilatory impairment
13.	IS 13450 (Part 2/Sec 80) : 2023 ISO 80601-2-80:2018	Medical electrical equipment Part 2 - Particular requirements for basic safety and essential performance Section 80 - Ventilatory support equipment for ventilatory insufficiency
14.	IS 13450 (Part 2/Sec 84) : 2023 ISO 80601-2-84:2020	Medical electrical equipment Part 2 - Particular requirements for basic safety and essential performance Section 84 Ventilators for emergency medical services environment
15.	IS/ISO 15002 : 2008 ISO15002:2008 Reviewed In : 2023	Flow - Metering devices for connection to terminal units of medical gas pipeline systems
16.	IS/ISO 18467 : 2024 ISO 16628 : 2022	Anaesthetic and Respiratory Equipment Tracheobronchial Tubes First Revision
17.	IS 17426 : 2020	ICU Ventilators for use in COVID-19 - Specification
18.	IS 17587 : 2021	Specification for Pedal operated resuscitator
19.	IS 17625 (Part 2/Sec 69) : 2021 ISO 80601-2-69 : 2020	Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 69 Oxygen Concentrator Equipment
20.	IS 17812 (Part 1) : 2022 ISO 9170-1:2017	Terminal Units for Medical Gas Pipeline Systems Part 1 Terminal Units for use with Compressed Medical Gases and Vacuum First Revision
21.	IS 18306 : 2023	Pneumatic Tourniquet- Specification
22.	IS 18361 (Part 1) : 2023	Pressure Regulators for use with Medical Gases Part 1 Pressure Regulators and Pressure Regulators with Flow-Metering Devices first revision
23.	IS 18361 (Part 2) : 2023 ISO 10524-2 : 2018	Pressure Regulators for use with Medical Gases Part 2 Manifold and line pressure regulators First Revision
24.	IS 18375 (Part 1) : 2023	Medical Suction Equipment Part 1 Electrically Powered Suction Equipment
25.	IS 18375 (Part 2) : 2023 ISO 10079-2:2022	Medical Suction Equipment Part 2 Manually Powered Suction Equipment Second Revision
26.	IS 18375 (Part 3) : 2023 ISO 10079-3:2022	Medical Suction Equipment Part 3 Suction Equipment Powered from a Vacuum or Positive pressure Gas Source Second Revision
27.	IS 18377 : 2024 ISO 5366:2016	Anaesthetic and Respiratory Equipment Tracheostomy Tubes and Connectors
28.	IS 18460 : 2024 ISO 8836:2019	Suction Catheters for Use in the Respiratory Tract
29.	IS 18691 : 2024 ISO 5367 : 2023	Anaesthetic and Respiratory Equipment-Breathing Sets and Connectors
30.	IS 18696 : 2024	Anaesthetic and Respiratory Equipment- Oropharyngeal Airways
31.	IS 18772 (Part 2/Sec 87) : 2024	Medical electrical equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 87 High Frequency Ventilators
32.	IS 18784 : 2024	Medical Devices Sleep Apnoea Breathing Therapy Masks and Application Accessories
33.	IS 18785 : 2024	Anaesthetic and Respiratory Equipment Low-Flow Nasal Cannulae for Oxygen Therapy
34.	IS 18805 : 2024 ISO 5359:2014	Anaesthetic and Respiratory Equipment Low-Pressure Hose Assemblies for Use with Medical Gases
35.	IS 18827 : 2024 ISO 5361:2023	Anaesthetic and respiratory equipment Tracheal tubes and connectors
36.	IS/ISO 26782 : 2009 ISO 26782:2009	Anaesthetic and respiratory equipment Spirometers intended for the measurement of time forced expired volumes in humans
37.	IS/ISO 27427 : 2013 Reviewed In : 2021	Anaesthetic and Respiratory Equipment - Nebulizing Systems and Components
38.	IS 3390 : 1988 Reviewed In : 2023	Specification for sphygmomanometers mercurial Second Revision
39.	IS 3391 : 1965 Reviewed In : 2023	Specification for stethoscopes
40.	IS 3392 : 1965 Reviewed In : 2023	Specification for anaesthetic airways
41.	IS 3393 : 2024	Mouth Props and Airways London Hospital Pattern Specification First Revision
42.	IS 4113 : 2022 ISO 7376:2020	Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation
43.	IS 4154 : 1967 Reviewed In : 2024	Specification for endotracheal connections
44.	IS/ISO 5356-1 : 2015 ISO 5356-1 : 2015 Reviewed In : 2022	Anaesthetic and respiratory equipment - Conical connectors Part 1 cones and sockets First Revision
45.	IS/ISO 5356-2 : 2012 Reviewed In : 2020	Anaesthetic and respiratory equipment - Conical connectors Part 2 screw - Threaded weight - Bearing connectors
46.	IS/ISO 5361 : 1999 ISO 5361 : 1999 Reviewed In : 2022	Anaesthetic and respiratory equipment - Tracheal tubes and connectors
47.	IS/ISO 5362 : 2006 ISO 5362 : 2006 Reviewed In : 2022	Anaesthetic reservoir bags
48.	IS/ISO 5364 : 2008 ISO 5364:2008 Reviewed In : 2024	Anaesthetic and respiratory equipment - Oropharyngeal airways
49.	IS/ISO 5366-1 : 2000 ISO 5366 Part 1 : 2000 Reviewed In : 2023	Anaesthetic and respiratory equipment - Tracheostomy tubes Part 1 tubes and connectors for use in adults
50.	IS/ISO 5367 : 2000 ISO 5367: 2000 Reviewed In : 2022	Breathing tubes intended for use with anaesthetic apparatus and ventilators
51.	IS 5622 : 1970 Reviewed In : 2021	Soda-Lime Canisters for Use with Gas Anaesthetic Apparatus Waters to-and-Fro
52.	IS 5680 : 1969 Reviewed In : 2020	Specification for rubber tubing for medical use
53.	IS 6190 : 1971 Reviewed In : 2024	Specification for anaesthetic face masks
54.	IS 6194 : 1971 Reviewed In : 2021	Specification for intermittent positive pressure respirator bag type manually operated
55.	IS 6207 : 1971 Reviewed In : 2023	Specification for trolleys for oxygen cylinders
56.	IS 6581 : 1972 Reviewed In : 2024	Specification for endotracheal tubes Rubber
57.	IS 6807 : 1972 Reviewed In : 2024	Specification for Reinforced Flexo-Metallic Magill 39 s Endotracheal Tube
58.	IS 7176 : 2024	Drawover Portable Type Anaesthetic Apparatus Specification Second Revision
59.	IS 7625 : 1975 Reviewed In : 2023	Gag Mouth Doyen s Pattern
60.	IS 7652 : 1988 Reviewed In : 2021	Specification for sphygmomanometer aneroid type First Revision
61.	IS 7885 : 1985 Reviewed In : 2023	Spray Macintosh s Pattern
62.	IS/IEC 80601-2-30 : 2018 IEC80601-2-30 : 2018 Reviewed In : 2024	Medical electrical equipment Part 2 - 30 particular requirements for basic safety and essential performance of automated non - Invasive sphygmomanometers
63.	IS/ISO 81060-1 : 2007 IEC81060_1 : 2007 Reviewed In : 2023	Non - Invasive sphygmomanometers Part 1 requirements and test methods for non - Automated measurement type
64.	IS 8254 (Part 1) : 2024	Valve Non-Rebreathing Specification Part 1 Ruben s Pattern First Revision
65.	IS 8254 (Part 2) : 2024	Valve Non-Rebreathing - Specification Part 2 Ambu-Hesse 39 s Pattern First Revision
66.	IS 8312 : 1977 Reviewed In : 2024	Forceps Introducing Endotracheal Tube Magill s Pattern
67.	IS 8432 : 1977 Reviewed In : 2019	Specification for tubes tracheostomy Rubber Or Plastics
68.	IS/ISO 9170-2 : 2008 ISO 9170 : Part 2 :2008 Reviewed In : 2022	Terminal units for medical gas pipeline systems Part 2 terminal units for anaesthetic gas scavenging systems
69.	IS 9462 : 1980 Reviewed In : 2023	Specification for humidifier nebulizing ventury type