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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS/ISO 7198 : 2016
ISO 7198 : 2016

IS Title/आईएस शीर्षक : Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches

Superseding IS/सुपरसीडिंग आईएस : None

Degree of Equivalence/समतुल्यता स्तर : Identical under single 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/ISO 7198 : 2016
ISO 7198 : 2016
:

1	IS/ISO 10993-5 : 2009 ISO 10993-5 : 2009	Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity	MHD 19
2	IS/ISO 10993-10 : 2010 ISO 10993-10 : 2010	Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization	MHD 19
3	IS/ISO 10993-15 : 2000 ISO 10993-15 : 2000	Biological evaluation of medical devices: Part 15 identification and quantification of degradation products from metals and alloys	MHD 19
4	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
5	IS/ISO 10993-9 : 2009 ISO 10993-9 : 2009	Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products	MHD 19
6	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
7	IS/ISO 10993-7 : 2018 ISO 10993-7 : 2008	Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals	MHD 19
8	IS/IEC/TS 10993-19 : 2006 ISO/TS 109993-19 : 2006	Biological Evaluation of Medical Devices Part 19 Physico-Chemical, Morphological and Topographical Characterization of Materials	MHD 19
9	IS/ISO 10993-4 : 2017 ISO 10993-4 : 2017	Biological evaluation of medical devices Part 4 Selection of tests for interactions with blood	MHD 19
10	IS/ISO 10993-11 : 2017 ISO 10993-11 : 2017	Biological evaluation of medical devices Part 11 Tests for systemic toxicity	MHD 19
11	IS/ISO 10993-16 : 2017 ISO 10993-16 : 2017	Biological Evaluation of Medical Devices Part 16 Toxicokinetic Study Design for Degradation Products and Leachables	MHD 19
12	IS/ISO 10993-6 : 2016 ISO 10993-6 : 2016	Biological evaluation of medical devices Part 6 Tests for local effects after implantation	MHD 19
13	IS/ISO 10993-3 : 2014 ISO 10993-3 : 2014	Biological evaluation of medical devices Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive toxicity (First Revision)	MHD 19
14	IS 11140 : 2024	Specification for footrest assembly for mopeds	TED 6
15	IS 11159 (Part 2) : 2021	Classification of lubricants industrial oils and related products: Part 2 family a (Total Loss Systems)	PCD 25
16	IS 11159 (Part 3) : 2021	Classification of lubricants, industrial oils and related products: Part 3 family f (Spindle Bearings, Bearings And Associated Clutches)	PCD 25
17	IS 11162 (Part 1) : 1985 Reviewed In : 2019	Dimensions of non - Insulated terminal tags for electronic equipment: Part 1 type 1	LITD 3
18	IS 3758 : 2018 Reviewed In : 2023	Hooks, aural - Specification (First Revision)	MHD 4
19	IS 6171 : 1992 5967-1981 Reviewed In : 2018	Screwing taps - Technical supply conditions (Second Revision)	PGD 32
20	IS 6780 : 2024	Thoracic Surgery Instruments - Forceps, Artery, Robert's Pattern, Curved on Flat	MHD 6
21	IS 7155 (Part 7) : 2023	Code of recommended practice for conveyor safety: Part 7 inspection and maintenance (First Revision)	MED 6

International Standards Referred In IS/ISO 7198 : 2016
ISO 7198 : 2016

1	ISO/TR 10993 : 33 : 2015
2	ISO 14160 : 2011
3	ISO 14630 : 2012
4	ISO 14937 : 2009
5	ISO 17665 : 1 : 2006
6	ISO/TS 17665 : 2 : 2009
7	ISO/TS 17665 : 3 : 2013

IS/ISO 7198 : 2016
ISO 7198 : 2016
is Referred in following Indian Standards :

1	IS/ISO 7198 : 2016	Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches	MHD 6
2	IS/ISO 7198 : 2016	Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches	MHD 6
3	IS/ISO 7198 : 2016	Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches	MHD 6
4	IS/ISO 7198 : 2016	Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches	MHD 6
5	IS/ISO 7198 : 2016	Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches	MHD 6
6	IS/ISO 7198 : 2016	Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches	MHD 6
7	IS/ISO 7198 : 2016	Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches	MHD 6
8	IS/ISO 7198 : 2016	Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches	MHD 6

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	:	Ministry of Health and Family Welfare
Sustainable development Goals :
Short Commom Man's Title	:
ITC-HS Code	:	N/A
Degree of Equivalence	:	Identical under single numbering
Identical/Equivalent International Standard(s)	:	IS/ISO 7198:2016
Harmonized with	:

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

List of Licenses under IS : IS/ISO 7198 : 2016

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/ISO 7198 : 2016

List of Expired or Cancelled Licenses under IS : IS/ISO 7198 : 2016

List of laboratories for : IS/ISO 7198 : 2016

List of Amendement(s) for : IS/ISO 7198 : 2016

List of Gazette Document(s) for : IS/ISO 7198 : 2016

List of Corigenda Document(s) for : IS/ISO 7198 : 2016

List of Product Manuals & SIT