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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS/ISO 18697-4 : 2024

IS Title/आईएस शीर्षक : Lung Ventilators Part 4 Particular Requirements for Userâ€“ Powered Resuscitators (ISO 10651-4 : 2023, MOD) (First Revision)

Superseding IS/सुपरसीडिंग आईएस : IS/ISO 10651 : Part 4 : 2002

Degree of Equivalence/समतुल्यता स्तर : Modified/Technically Equivalent

Number of Revisions/पुनरीक्षणों की संख्या : 1

Number of Amendments/संशोधनों की संख्या : No amendment issued

Aspect/पक्ष : Product Specification

Language/भाषा : English

Reaffirmation Year/पुनर्पुष्टि वर्ष : No reaffirmation

Technical Department/तकनीकी विभाग : MHD (Medical Equipment and Hospital Planning Department)

Technical Committee/तकनीकी समिति : MHD 11 (Anesthetic, Resuscitation and Allied Equipment Sectional Committee)

Member Secretary/सदस्य सचिव : Mr. Satyam Rathore (SCIENTIST-B)

Other Details

Indian Standard

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Amendment : 0

Gazette Document : 4

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License : 0

Product Manual & SIT : 0

Laboratory : 0

Classification Details

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Cross Reference Details

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Composition

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Corrigendum : 0

Cross Reference Details

Indian Standards Referred In IS IS/ISO 18697-4 : 2024
:

1	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)	MHD 11
2	IS 18852 (Part 1) : 2024 ISO 7755-1:2013	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD)	MHD 19
3	IS/ISO/IEC 23736-3 : 2020 ISO/IEC 23736-3: 2020	Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices	MHD 12
4	IS/ISO/IEC 23736-3 : 2020 ISO/IEC 23736-3: 2020	Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices	MHD 12
5	IS/ISO 14937 : 2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices	MHD 12
6	IS 17781 : 2021	Medical devices - Application of risk management to medical devices First Revision	MHD 14
7	IS 9000 (Part 7/Sec 3) : 2019 IEC 60068-2-31 : 2008 Reviewed In : 2022	Environmental testing: Part 7 tests :: Sec 3 test Ec: rough handling shocks, primarily for equipment - Types specimens (First Revision)	LITD 1
8	IS 17922 : Part 1 : 2023	Medical Devices Part 1: Application of Usability Engineering	MHD 14
9	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)	MHD 11
10	IS 18852 (Part 1) : 2024 ISO 7755-1:2013	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD)	MHD 19
11	IS/ISO/IEC 23736-3 : 2020 ISO/IEC 23736-3: 2020	Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices	MHD 12
12	IS/ISO/IEC 23736-3 : 2020 ISO/IEC 23736-3: 2020	Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices	MHD 12
13	IS/ISO 14937 : 2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices	MHD 12
14	IS 17781 : 2021	Medical devices - Application of risk management to medical devices First Revision	MHD 14
15	IS 9000 (Part 7/Sec 3) : 2019 IEC 60068-2-31 : 2008 Reviewed In : 2022	Environmental testing: Part 7 tests :: Sec 3 test Ec: rough handling shocks, primarily for equipment - Types specimens (First Revision)	LITD 1
16	IS 17922 : Part 1 : 2023	Medical Devices Part 1: Application of Usability Engineering	MHD 14

International Standards Referred In IS/ISO 18697-4 : 2024

1	ISO 11195 : 2018
2	ISO 18562 : 1 : 2017
3	ISO 23328 : 1 : 2003
4	ISO 23328 : 2 : 2002
5	ISO 80369 : 2 : 0 0
6	IEC 62570 : 2014
7	IEC 115 : 2021
8	EN 13544 : 2 : 2002
9	ISO 11195 : 2018
10	ISO 18562 : 1 : 2017
11	ISO 23328 : 1 : 2003
12	ISO 23328 : 2 : 2002
13	ISO 80369 : 2 : 0 0
14	IEC 62570 : 2014
15	IEC 115 : 2021
16	EN 13544 : 2 : 2002

IS/ISO 18697-4 : 2024
is Referred in following Indian Standards :

1	IS 8034 : 2002	Submersible Pumpsets - Specification	MED 20

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Clinical, pathological, anaesthetic and respiratory equipments and systems
Sub Sub Group	:	Diagnostic , anaesthetic and respiratory equipment
Aspect	:	Product Specification
Certification	:	Voluntary Certification
Relevant Ministries	:	Ministry of Health and Family Welfare
Sustainable development Goals :
Short Commom Man's Title	:
ITC-HS Code	:
Degree of Equivalence	:	Modified/Technically Equivalent
Identical/Equivalent International Standard(s)	:	ISO 10651-4:2023
Harmonized with	:	ISO

ID	Mailing list	Download
1	Committee members email list	Download
3	Additional mailing list	Download

List of Licenses under IS : IS/ISO 18697 : Part 4 : 2024

ID	Licence No.	Firm Name & Address	District	State	Validity Date	Status	Variety	Brand Name	Scale

ID	Licence No.	Firm Name & Address	District	State	Validity Date	Status	Variety	Brand Name	Scale

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Basic Details/ मूल ब्यौरा

Other Details

Indian Standard

Amendment : 0

Gazette Document : 4

License : 0

Product Manual & SIT : 0

Laboratory : 0

Classification Details

Cross Reference Details

Composition

Corrigendum : 0

Cross Reference Details

Classification Details

Email Ids

List of Licenses under IS : IS/ISO 18697 : Part 4 : 2024

List of Expired or Cancelled Licenses under IS : IS/ISO 18697 : Part 4 : 2024

List of laboratories for : IS/ISO 18697 : Part 4 : 2024

List of Amendement(s) for : IS/ISO 18697 : Part 4 : 2024

List of Gazette Document(s) for : IS/ISO 18697 : Part 4 : 2024

List of Corigenda Document(s) for : IS/ISO 18697 : Part 4 : 2024

List of Product Manuals & SIT