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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 18766 (Part 1) : 2025

IS Title/आईएस शीर्षक : Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process

Superseding IS/सुपरसीडिंग आईएस : None

Degree of Equivalence/समतुल्यता स्तर : Modified/Technically Equivalent

Number of Revisions/पुनरीक्षणों की संख्या : New Standard

Number of Amendments/संशोधनों की संख्या : No amendment issued

Aspect/पक्ष : Methods of tests

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 : 1

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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 18766 (Part 1) : 2025
:

1	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
2	IS/ISO 10993-17 : 2002 ISO 10993-17 : 2002	Biological Evaluation of Medical Devices Part 17 Establishment of Allowable Limits for Leachable Substances	MHD 19
3	IS 17781 : 2021	Medical devices - Application of risk management to medical devices First Revision	MHD 14
4	IS 17400 : 2021
5	IS 9234 (Part 2) : 2021
6	IS 548 (Part 1/Sec 1) : 2021	Phosphorus Pentachloride, Technical	CHD 1

International Standards Referred In IS 18766 (Part 1) : 2025

Standard contains no Cross Referenced International Standard.

IS 18766 (Part 1) : 2025
is Referred in following Indian Standards :

1	IS 13450 : Part 2 : Sec 21 : 2023	Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 21 Infant Radiant Warmer First Revision	MHD 15
2	IS 13450 : Part 2 : Sec 21 : 2023	Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 21 Infant Radiant Warmer First Revision	MHD 15
3	IS 13450 : Part 2 : Sec 21 : 2023	Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 21 Infant Radiant Warmer First Revision	MHD 15

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Clinical, pathological, anaesthetic and respiratory equipments and systems
Sub Sub Group	:	Biological tests
Aspect	:	Methods of tests
Certification	:	Voluntary Certification
Relevant Ministries	:	Ministry of Health and Family Welfare
Sustainable development Goals :
Short Commom Man's Title	:
ITC-HS Code	:	N/A
Degree of Equivalence	:	Modified/Technically Equivalent
Identical/Equivalent International Standard(s)	:	ISO 18562-1: 2024
Harmonized with	:	ISO

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

List of Licenses under IS : IS 18766 : Part 1 : 2025

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 : 1

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 18766 : Part 1 : 2025

List of Expired or Cancelled Licenses under IS : IS 18766 : Part 1 : 2025

List of laboratories for : IS 18766 : Part 1 : 2025

List of Amendement(s) for : IS 18766 : Part 1 : 2025

List of Gazette Document(s) for : IS 18766 : Part 1 : 2025

List of Corigenda Document(s) for : IS 18766 : Part 1 : 2025

List of Product Manuals & SIT