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Indian Standard Details

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Basic Details
IS Number : IS/ISO 5840-2 : 2015
IS Title [Eng-Hn] : Cardiovascular Implants Cardiac Valve Prostheses Part 2 Surgically Implanted Heart Valve Substitutes
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

Classification Details
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:ISO 5840-2 : 2015
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS/ISO 5840 : Part 2 : 2015 :
SNo IS Number Title Technical Committee
1
IS/ISO/IEC 17025 : 2017 General requirements for the competence of testing and calibration laboratories (Second Revision) MSD 14
2
IS/ISO 10993 : Part 1 : 2009 Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process MHD 19
3
IS/ISO 22442 : Part 1 : 2015 Medical Devices Utilizing Animal Tissues and their Derivatives Part 1 Application of Risk Management MHD 19
4
IS/ISO 22442 : Part 2 : 2015 Medical Devices Utilizing Animal Tissues and their Derivatives Part 2 Controls on Sourcing, Collection and Handling MHD 19
5
IS/ISO 14971 : 2007 Medical devices - Application of risk management to medical devices MHD 14
6
IS/ISO 14155 : 2011 Clinical investigation of medical devices for human subjects - Good clinical practice MHD 19
7
IS 66 : 2006 Magnesium silicate pigments for paints - Specification (Second Revision) CHD 21
International Standards Refered In IS/ISO 5840 : Part 2 : 2015
SNo International Standard Number
1 ISO 9001 : 2015
2 ISO 17000 : 2004
IS/ISO 5840 : Part 2 : 2015 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS/ISO 5840 : Part 2 : 2015 Cardiovascular Implants Cardiac Valve Prostheses Part 2 Surgically Implanted Heart Valve Substitutes MHD 6