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Indian Standard Details

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Basic Details
IS Number : IS/ISO 15674-2004 : 2016
ISO 15674 : 2016
Reviewed In : 2022
IS Title [Eng-Hn] : Cardiovascular implants and artificial organs - Hard - Shell cardiotomy/venous reservoir systems (With/without Filter) and soft venous reservoir bags (Second Revision)
No of Revision : 2
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 6 ( Medical and Surgical Cardiology Equipment )
Language : English

Classification Details
Group : Medical and Hospital Equipments
Sub Group: Surgical instruments and accessories
Sub Sub Group : Thoracic surgery instruments
Aspects: Product Specification
Certification:
Ministry : Ministry of Health and Family Welfare
Short Commom Man's Title:
Itchs:
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:IS/ISO 15674 : 2016
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS/ISO 15674 : 2016 :
SNo IS Number Title Technical Committee
1
IS/ISO 11607 : Part 2 : 2006 Packaging for terminally sterilized medical devices: Part 2 validation requirements for forming, sealing and assembly processes MHD 12
2
IS/ISO 11607 : Part 1 : 2006 Packaging for terminally sterilized medical devices: Part 1 requirements for materials, sterile barrier systems and packaging systems MHD 12
3
IS/ISO 10993 : Part 1 : 2009 Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process MHD 19
4
IS/ISO 10993 : Part 7 : 2018 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals MHD 19
5
IS 6102 : Part 1 : 2009 Finger knobs used in electronic and telecommunication equipment - Specificaiton: Part 1 general requirements and tests (First Revision) LITD 3
International Standards Refered In IS/ISO 15674 : 2016 Standard contains no Cross Referenced International Standard.
IS/ISO 15674 : 2016 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS/ISO 15674 : 2016 Cardiovascular implants and artificial organs - Hard - Shell cardiotomy/venous reservoir systems (With/without Filter) and soft venous reservoir bags (Second Revision) MHD 6
2 IS 14700 : Part 4 : Sec 1 : 2019 Electromagnetic compatibility (EMC): Part 4 testing and measurement techniques: Sec 1 overview of the IEC 61000 - 4 series (Second Revision) LITD 9