Indian Standard Details

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IS Number : IS/ISO 14155 : 2011
ICS 11.100.20

IS Title [Eng-Hn] : Clinical investigation of medical devices for human subjects - Good clinical practice
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: Clinical, pathological, anaesthetic and respiratory equipments and systems
Sub Sub Group : Biological tests
Aspects: Methods of tests
Certification:
Ministry :
Short Commom Man's Title:
Itchs:
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:ISO 14155: 2020
Organisation :

Indian Standards Refered In IS IS/ISO 14155 : 2011 :
SNo IS Number Title Technical Committee
1
IS/ISO 14971 : 2019 Medical devices - Application of risk management to medical devices First Revision MHD 14
International Standards Refered In IS/ISO 14155 : 2011
SNo International Standard Number
1 EN 14164 : 0 : 2014 0
IS/ISO 14155 : 2011 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS/ISO 12417 : Part 1 : 2015 Cardiovascular Implants and Extracorporeal Systems Vascular Device-Drug Combination Products Part 1 General Requirements MHD 6
2 IS/ISO 5840 : Part 2 : 2015 Cardiovascular Implants Cardiac Valve Prostheses Part 2 Surgically Implanted Heart Valve Substitutes MHD 6
3 IS 12725 : 2021 Pneumatic Fluid Power - General Rules and Safety Requirements for Systems and their Components ( Second Revision ) PGD 36
4 IS 16693 : 2021 Reference sources - Calibration of surface contamination monitors - Alpha beta and photon emitters (First Revision) CHD 30
5 IS 17545 : 2021 White cement based polymeric putty CHD 20
6 IS 3025 : Part 71 : 2021 Methods of Sampling and Test (Physical and Chemical) for Water and Wastewater Part 71 Determination of Dissolved Cations Using Ion Chromatography CHD 36
7 IS/ISO 80601 : Part 2 : Sec 61 : 2011 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 61 pulse oximeter equipment MHD 15
8 IS 16143 : Part 6 : 2021 Hard coal and coke - Mechanical sampling : Part 6 coke - preparation of test samples (First Revision) PCD 7
9 IS 101 : Part 2 : Sec 4 : 2022 Methods of sampling and test for paints varnishes and related products: Part 2 test on liquid paints chemical examination : Sec 4 determination of volatile organic compound voc and or semi volatile organic compounds svoc content gas-chromatographic (First Revision) CHD 20
10 IS/ISO 105-B03 : 2017 Textiles Tests for colour fastness Part B03: Colour fastness to weathering: Outdoor exposure first revision of ISISO 105 B03 TXD 5