Indian Standard Details

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IS Number : IS/ISO 14971 : 2007
ISO 14971 : 2007

IS Title [Eng-Hn] : Medical devices - Application of risk management to medical devices
No of Revision : 0
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: Health care facilities
Sub Sub Group : Quality Management of hospitals
Aspects: Code of Practice
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 14971 : 2019
Organisation :

Indian Standards Refered In IS IS/ISO 14971 : 2007 :
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 14971 : 2007 Standard contains no Cross Referenced International Standard.
IS/ISO 14971 : 2007 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS/ISO 25539 : Part 1 : 2017 Cardiovascular implants - Endovascular devices: Part 1 endovascular prostheses (First Revision) MHD 6
2 IS/ISO 12417 : Part 1 : 2015 Cardiovascular Implants and Extracorporeal Systems Vascular Device-Drug Combination Products Part 1 General Requirements MHD 6
3 IS/ISO/TS 22367 : 2008 Medical Laboratories - Reduction of Error through Risk Management and Continual Improvement MHD 14
4 IS/IEC 62366 : Part 1 : 2015 Medical Devices Part 1 Application of Usability Engineering to Medical Devices MHD 14
5 IS/IEC/TR 62366 : Part 2 : 2016 Medical devices Part 2 Guidance on the Application of Usability Engineering to Medical Devices MHD 14
6 IS/ISO 15198 : 2004 Clinical Laboratory Medicine - In vitro Diagnostic Medical Devices - Validation of User Quality Control Procedures by the Manufacturer MHD 19
7 IS/ISO 5840 : Part 2 : 2015 Cardiovascular Implants Cardiac Valve Prostheses Part 2 Surgically Implanted Heart Valve Substitutes MHD 6
8 IS/ISO 5840 : Part 3 : 2013 Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Trans-Catheter Techniques MHD 6
9 IS 13450 : Part 4 : Sec 1 : 2020 Medical electrical equipment: Part 4 Guidance and interpretation: Section 1 Medical electrical equipment and medical electrical systems employing a degree of autonomy PGD 18
10 IS/ISO 14971 : 2007 Medical devices - Application of risk management to medical devices MHD 14
11 IS/ISO 80601 : Part 2 : Sec 12 : 2011 MEDICAL ELECTRICAL EQUIPMENT PART 2-12 PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS MHD 15
12 IS 12725 : 2021 Pneumatic Fluid Power - General Rules and Safety Requirements for Systems and their Components ( Second Revision ) PGD 36
13 IS/IEC 80601 : Part 2 : Sec 35 : 2009 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 35 Heating devices using blankets, pads or mattresses and intended for heating in medical use MHD 15
14 IS/ISO 10524 : Part 3 : 2005 Pressure regulators for use with medical gases: Part 3 pressure regulators integrated with cylinder valves MHD 11
15 IS/ISO 27427 : 2013 Anaesthetic and Respiratory Equipment - Nebulizing Systems and Components MHD 11
16 IS 16693 : 2021 Reference sources - Calibration of surface contamination monitors - Alpha beta and photon emitters (First Revision) CHD 30
17 IS 10258 : Part 3 : 2010 Sterile hypodermic syringes for single use: Part 3 auto - Disable syringes for fixed - Dose immunization MHD 12
18 IS 17545 : 2021 White cement based polymeric putty CHD 20
19 IS/ISO 6722 : Part 1 : 2011 Road vehicles -- 60 V and 600 V single-core cables -- Part 1: Dimensions test methods and requirements for copper conductor cables TED 11
20 IS 14147 : Part 1 : 2021 Identification Cards Recording Technique Part 1 Embossing LITD 16
21 IS/ISO 11197 : 2016 Medical supply units MHD 11
22 IS 1060 : Part 5 : Sec 12 : 2021 Method of Sampling and Test for Paper and Allied Products Part 5 Method of Test for Paper and Board Section 12 Measurement of specular gloss 75 degree gloss with a converging beam TAPPI method CHD 15
23 IS 229 : 2021 Ethyl acetate - Specification (Fourth Revision) PCD 9
24 IS 15748 : 2022 Protective clothing - Clothing to protect against heat and flame - Minimum performance requirements (first revision) TXD 32
25 IS 11563 : 2022 TECHNICAL SUPPLY CONDITIONS FOR DYNAMIC COMPRESSORS MED 22