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Indian Standard Details

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Basic Details
IS Number : IS/ISO 80601-2-61 : 2017
ISO 80601-2-61:2017
IS Title [Eng-Hn] : Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
No of Revision : 1
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 15 ( Electromedical, Diagnostic Imaging and Radiotherapy Equipment )
Language : English

Classification Details
Group : Medical and Hospital Equipments
Sub Group: Diagnostic Instruments
Sub Sub Group : Equipment/Instruments used for diagnostic and clinical purpose
Aspects: Product Specification
Certification:
Ministry :
Short Commom Man's Title:
Itchs:
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:ISO 80601-2-61:2017
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS/ISO 80601 : Part 2 : Sec 61 : 2017 :
SNo IS Number Title Technical Committee
1
IS 9000 : Part 7 : Sec 1 : 2018 Basic environmental testing procedures for electronic and electrical items: Part 7 impact test: Sec 1 shock (Test Ea) (Second Revision) LITD 1
2
IS 13200 : 2015 Anaesthetic and respiratory equipment - Vocabulary (First Revision) MHD 11
3
IS 13450 : Part 1 : 2018 Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision) MHD 15
4
IS/ISO 14155 : 2011 Clinical investigation of medical devices for human subjects - Good clinical practice MHD 19
5
IS 14624 : Part 2 : 2012 Safety of laser products: Part 2 safety of optical fibre communication systems (OFCS) (First Revision) LITD 11
6
IS/ISO 15223 : Part 1 : 2016 Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( Second Revision ) MHD 14
7
IS 16450 : 2017 Graphical symbols for use on equipment - Registered symbols PGD 1
8
IS 16451 : 2018 Graphical Symbols- Safety Colours and Safety Signs- Registered Safety Signs PGD 1
9
IS/IEC 62366 : Part 1 : 2015 Medical Devices Part 1 Application of Usability Engineering to Medical Devices MHD 14
International Standards Refered In IS/ISO 80601 : Part 2 : Sec 61 : 2017
SNo International Standard Number
1 IEC 60068 : 2 : 47 2005
2 IEC 104 : 1997
IS/ISO 80601 : Part 2 : Sec 61 : 2017 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS/ISO 80601 : Part 2 : Sec 61 : 2017 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment MHD 15