Indian Standard Details

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IS Number : IS 19173 (Part 1):2025

IS Title [Eng-Hn] : Medical Device Software Part 1 Guidance on the Application of ISO 14971 to Medical Device Software
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 - Department of Health and Family Welfare
Short Commom Man's Title: Guidance on the Application of ISO 14971 to Medical Device Software
Itchs: N/A
Degree of Equivalence: Modified/Technically Equivalent
Identical/Equivalent Standards:IEC/TR 80002-1 : 2009
Organisation :

Indian Standards Refered In IS IS 19173 : Part 1 : 2025 :
SNo IS Number Title Technical Committee
1
IS/ISO 62304 : 2015 Medical device software - Software life cycle processes MHD 14
2
IS/ISO 14971 : 2019 Medical devices - Application of risk management to medical devices First Revision MHD 14
International Standards Refered In IS 19173 : Part 1 : 2025
SNo International Standard Number
1 IEC 60336 : 0 : 0 0
2 ISO 60788 : 2004
3 IEC 61267 : 2005
IS 19173 : Part 1 : 2025 is Refered in following Indian Standards : Standard contains no Cross Referenced Indian Standard.