Indian Standard Details

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IS Number : IS/ISO 15198 : 2004
ISO 15198 : 2004

IS Title [Eng-Hn] : Clinical Laboratory Medicine - In vitro Diagnostic Medical Devices - Validation of User Quality Control Procedures by the Manufacturer
No of Revision : 0
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 19 ( In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices )
Language : English

Group : Medical and Hospital Equipments
Sub Group: Health care facilities
Sub Sub Group : Hospital Planning
Aspects: Code of Practice
Certification:
Ministry : Ministry of Health and Family Welfare
Short Commom Man's Title:
Itchs:
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:ISO 15198:2004
Organisation :

Indian Standards Refered In IS IS/ISO 15198 : 2004 :
SNo IS Number Title Technical Committee
1
IS 15393 : Part 1 : 2003 Accuracy (Trueness And Precision) of measurement methods and results: Part 1 general principles and definitions MSD 3
2
IS 7920 : Part 1 : 2012 Statistical - Vocabulary and symbols: Part 1 general statistical terms and terms used in probability (Third Revision) MSD 3
3
IS/ISO 13485 : 2016 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ) MHD 14
4
IS/ISO 14971 : 2007 Medical devices - Application of risk management to medical devices MHD 14
International Standards Refered In IS/ISO 15198 : 2004
SNo International Standard Number
1 ISO 3534 : 1 : 0 0
2 ISO 5725 : 2 : 0 0
3 ISO 5725 : 3 : 0 0
4 ISO 5725 : 4 : 0 0
IS/ISO 15198 : 2004 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS 17881 : Part 1 : 2022 Protective clothing against heat and flame - Part 1 Test method for complete garments - Measurement of transferred energy using an instrumented manikin TXD 32