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Indian Standard Details

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Basic Details
IS Number : IS/ISO 5840-3 : 2013
ISO 5840-3 : 2013 ‘

IS Title [Eng-Hn] : Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Trans-Catheter Techniques
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 5840-3 : 2013
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS/ISO 5840 : Part 3 : 2013 :
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 11607 : Part 2 : 2006 Packaging for terminally sterilized medical devices: Part 2 validation requirements for forming, sealing and assembly processes MHD 12
3
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
4
IS/ISO 10993 : Part 1 : 2009 Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process MHD 19
5
IS/ISO 11137 : Part 1 : 2006 Sterilization of health care products - Radiation: Part 1 requirements for development, validation and routine control of a sterilization process for medical devices MHD 12
6
IS/ISO 11135 : 2014 Sterilization of health - Care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices MHD 12
7
IS/ISO 11137 : Part 2 : 2013 Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose MHD 12
8
IS/ISO 22442 : Part 1 : 2015 Medical Devices Utilizing Animal Tissues and their Derivatives Part 1 Application of Risk Management MHD 19
9
IS/ISO 22442 : Part 2 : 2015 Medical Devices Utilizing Animal Tissues and their Derivatives Part 2 Controls on Sourcing, Collection and Handling MHD 19
10
IS/ISO 14971 : 2007 Medical devices - Application of risk management to medical devices MHD 14
11
IS/ISO 11137 : Part 3 : 2017 Sterilization of Health Care Products ― Radiation Part 3 Guidance on Dosimetric Aspects of Development, Validation and Routine Control MHD 12
12
IS/IEC 62366 : Part 1 : 2015 Medical Devices Part 1 Application of Usability Engineering to Medical Devices MHD 14
13
IS/IEC/TR 62366 : Part 2 : 2016 Medical devices Part 2 Guidance on the Application of Usability Engineering to Medical Devices MHD 14
International Standards Refered In IS/ISO 5840 : Part 3 : 2013
SNo International Standard Number
1 ISO 9001 : 2015
2 ISO 17000 : 2004
IS/ISO 5840 : Part 3 : 2013 is Refered in following Indian Standards : Standard contains no Cross Referenced Indian Standard.