Indian Standard Details

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IS Number : IS/ISO 13485 : 2016


IS Title [Eng-Hn] : Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision )
No of Revision : 1
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 14 ( Hospital Planning )
Language : English

Group : Medical and Hospital Equipments
Sub Group: Medical and Hospital Equipments
Sub Sub Group : Allied hospital equipment
Aspects: System Standard
Certification:
Ministry :
Short Commom Man's Title: Medical devices-Quality management systems- Requirements for regulatory purposes
Itchs:
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:ISO 13485:2016
Organisation :

Indian Standards Refered In IS IS/ISO 13485 : 2016 :
SNo IS Number Title Technical Committee
Standard contains no Cross Referenced Indian Standard.
Standard contains no Cross Referenced Indian Standard.
International Standards Refered In IS/ISO 13485 : 2016 Standard contains no Cross Referenced International Standard.
IS/ISO 13485 : 2016 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS/ISO 13022 : 2012 Medical products containing viable human cells - Application of risk management and requirements for processing practices MHD 19
2 IS/ISO 25539 : Part 1 : 2017 Cardiovascular implants - Endovascular devices: Part 1 endovascular prostheses (First Revision) MHD 6
3 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
4 IS/ISO 13485 : 2016 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ) MHD 14
5 IS/ISO 15198 : 2004 Clinical Laboratory Medicine - In vitro Diagnostic Medical Devices - Validation of User Quality Control Procedures by the Manufacturer MHD 19
6 IS 3565 : 1966 Rubber Teats for Feeding Bottles PCD 13
7 IS/ISO 6016 : 2008 Earth-Moving Machinery — Methods of Measuring the Masses of Whole Machines, their Equipment and Components MED 7
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