Indian Standard Details

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IS Number : IS/ISO 7198 : 2016
ISO 7198 : 2016

IS Title [Eng-Hn] : Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches
No of Revision : 0
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 6 ( Medical and Surgical Cardiology Equipment )
Language : English

Group : Medical and Hospital Equipments
Sub Group: Implants
Sub Sub Group : Cardiovascular surgery instrument and implants
Aspects: Product Specification
Certification:
Ministry : Ministry of Health and Family Welfare
Short Commom Man's Title:
Itchs: N/A
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:IS/ISO 7198:2016
Organisation :

Indian Standards Refered In IS IS/ISO 7198 : 2016 :
SNo IS Number Title Technical Committee
1
IS/ISO 10993 : Part 5 : 2009 Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity MHD 19
2
IS/ISO 10993 : Part 10 : 2010 Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization MHD 19
3
IS/ISO 10993 : Part 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 : Part 17 : 2002 Biological Evaluation of Medical Devices Part 17 Establishment of Allowable Limits for Leachable Substances MHD 19
5
IS/ISO 10993 : Part 9 : 2009 Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products MHD 19
6
IS/ISO 10993 : Part 1 : 2009 Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process MHD 19
7
IS/ISO 10993 : Part 7 : 2018 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals MHD 19
8
IS/IEC/TS 10993 : Part 19 : 2006 Biological Evaluation of Medical Devices Part 19 Physico-Chemical, Morphological and Topographical Characterization of Materials MHD 19
9
IS/ISO 10993 : Part 4 : 2017 Biological evaluation of medical devices Part 4 Selection of tests for interactions with blood MHD 19
10
IS/ISO 10993 : Part 11 : 2017 Biological evaluation of medical devices Part 11 Tests for systemic toxicity MHD 19
11
IS/ISO 10993 : Part 16 : 2017 Biological Evaluation of Medical Devices Part 16 Toxicokinetic Study Design for Degradation Products and Leachables MHD 19
12
IS/ISO 10993 : Part 6 : 2016 Biological evaluation of medical devices Part 6 Tests for local effects after implantation MHD 19
13
IS/ISO 10993 : Part 3 : 2014 Biological evaluation of medical devices Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive toxicity (First Revision) MHD 19
14
IS 11140 : 1984 Specification for footrest assembly for mopeds TED 6
15
IS 11159 : Part 2 : 1989 Classification of lubricants industrial oils and related products: Part 2 family a (Total Loss Systems) PCD 25
16
IS 11159 : Part 3 : 1989 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 Dimensions of non - Insulated terminal tags for electronic equipment: Part 1 type 1 LITD 3
18
IS 3758 : 2018 Hooks, aural - Specification (First Revision) MHD 4
19
IS 6171 : 1992 Screwing taps - Technical supply conditions (Second Revision) PGD 32
20
IS 6780 : 1989 Thoracic Surgery Instruments - Forceps, Artery, Robert's Pattern, Curved on Flat MHD 6
21
IS 7155 : Part 7 : 1990 Code of recommended practice for conveyor safety: Part 7 inspection and maintenance (First Revision) MED 6
International Standards Refered In IS/ISO 7198 : 2016 Standard contains no Cross Referenced International Standard.
IS/ISO 7198 : 2016 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
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