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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 17750 (Part 5) : 2021
ISO 14708-5:2020

IS Title/आईएस शीर्षक : Implants for surgery Active Implantable Medical Devices Part 5: Circulatory Support Devices

Superseding IS/सुपरसीडिंग आईएस : None

Degree of Equivalence/समतुल्यता स्तर : Identical under dual numbering

Number of Revisions/पुनरीक्षणों की संख्या : New Standard

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 06 (Medical and Surgical Cardiology Equipment Sectional Committee)

Member Secretary/सदस्य सचिव : Mr. PAWAN KUMAR (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 17750 (Part 5) : 2021
ISO 14708-5:2020
:

1	IS 9001 (Part 1) : 1984 Reviewed In : 2019	Guidance for environmental testing: Part 1 General	LITD 1
2	IS/ISO 10993-1 : 2009 ISO 10993-1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
3	IS 13450 (Part 1/Sec 6) : 2024	Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 6 Collateral standard: Usability	MHD 15
4	IS 13450 (Part 1/Sec 10) : 2024	Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 10 Collateral standard: Requirements for the development of physiologic closed-loop controllers	MHD 15
5	IS 13450 (Part 1/Sec 11) : 2024	Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 11 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment	MHD 15
6	IS/ISO 14708-1 : 2014 ISO 14708-1 : 2014 Reviewed In : 2023	Implants for surgery - Active implantable medical devices: Part 1 general requirements for safety, marking and for information to be provided by the manufacturer (First Revision)	MHD 7
7	IS 17781 : 2021	Medical devices - Application of risk management to medical devices First Revision	MHD 14
8	IS/IEC 62366-1 : 2015 IEC 62366-1 : 2015 â€˜	Medical Devices Part 1 Application of Usability Engineering to Medical Devices	MHD 14

International Standards Referred In IS 17750 (Part 5) : 2021
ISO 14708-5:2020

1	IEC 60068 : 2 : 27 2008
2	IEC 60068 : 2 : 31 2008
3	IEC 60068 : 2 : 64 2008
4	IEC 60601 : 1 : 2 2014
5	IEC 62304 : 2006

IS 17750 (Part 5) : 2021
ISO 14708-5:2020
is Referred in following Indian Standards :

Standard contains no Cross Referenced Indian Standard.

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Implants
Sub Sub Group	:	Cardiovascular surgery instrument and implants
Aspect	:	Product Specification
Certification	:	Voluntary Certification
Relevant Ministries	:
Sustainable development Goals :
Short Commom Man's Title	:
ITC-HS Code	:	N/A
Degree of Equivalence	:	Identical under dual numbering
Identical/Equivalent International Standard(s)	:	ISO 14708-5:2020
Harmonized with	:	ISO

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

List of Licenses under IS : IS 17750 : Part 5 : 2021

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 17750 : Part 5 : 2021

List of Expired or Cancelled Licenses under IS : IS 17750 : Part 5 : 2021

List of laboratories for : IS 17750 : Part 5 : 2021

List of Amendement(s) for : IS 17750 : Part 5 : 2021

List of Gazette Document(s) for : IS 17750 : Part 5 : 2021

List of Corigenda Document(s) for : IS 17750 : Part 5 : 2021

List of Product Manuals & SIT