Indian Standard Details

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IS Number : IS 13450 (Part 1/Sec 11) : 2024

IS Title [Eng-Hn] : Medical electrical equipment : Part 1 General requirements for basic safety and essential performance , Section 11 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (First Revison)
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

Group : Medical and Hospital Equipments
Sub Group: Diagnostic Instruments
Sub Sub Group : Surgical, Diagnostic equipment and General safety requirements
Aspects: Others
Certification:
Ministry : Ministry of Health and Family Welfare
Short Commom Man's Title:
Itchs:
Degree of Equivalence: Modified/Technically Equivalent
Identical/Equivalent Standards:IEC 60601-1-11:2020
Organisation :

Indian Standards Refered In IS IS 13450 : Part 1 : Sec 11 : 2024 :
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 9000 : Part 7 : Sec 3 : 2019 Environmental testing: Part 7 tests :: Sec 3 test Ec: rough handling shocks, primarily for equipment - Types specimens (First Revision) LITD 1
3
IS 16450 : 2023 Graphical Symbols for Use on Equipment Registered Symbols PGD 1
4
IS 16451 : 2023 Graphical Symbols Safety Colours and Safety Signs Registered Safety Signs PGD 1
5
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
6
IS 16483 : 2017 Geosynthetics - Method for microscopic evaluation of the dispersion of carbon black in polyolefin geosynthetics TXD 30
7
IS 16621 : 2017 Positive list of constituents of polyethylene and polypropylene in contact with foodstuffs, pharmaceuticals and drinking water PCD 12
8
IS 16648 : Part 1 : 2017 Concentrated solar thermal - Specification: Part 1 paraboloid dish concentrator MED 4
9
IS/ISO 10993 : Part 10 : 2010 Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization MHD 19
10
IS/ISO 10993 : Part 15 : 2000 Biological evaluation of medical devices: Part 15 identification and quantification of degradation products from metals and alloys MHD 19
11
IS/IEC 60884 : Part 2 : Sec 5 : 1995 Plugs and Socket-Outlets for Household and Similar Purposes Part 2 Particular Requirements DSection 5 Adaptors ETD 14
International Standards Refered In IS 13450 : Part 1 : Sec 11 : 2024
SNo International Standard Number
1 IEC 60068 : 2 : 47 2005
2 IEC 104 : 1997
IS 13450 : Part 1 : Sec 11 : 2024 is Refered in following Indian Standards : Standard contains no Cross Referenced Indian Standard.