Indian Standard Details

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IS Number : IS 13450 (Part 1/Sec 11) : 2020
IEC 60601-1-11 : 2015

IS Title [Eng-Hn] : Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 11 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
No of Revision : 0
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 :
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 : 2020 :
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 : 2020
SNo International Standard Number
1 IEC 60068 : 2 : 47 2005
2 IEC 104 : 1997
IS 13450 : Part 1 : Sec 11 : 2020 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS 17567 : Part 1 : 2021 ISO TS 19807-1:2019 Nanotechnologies Magnetic nanomaterials Part 1: Specification of characteristics and measurements for magnetic nanosuspensions MTD 33
2 IS 13450 : Part 2 : Sec 26 : 2018 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 26 Electroencephalographs MHD 15
3 IS 17754 : Part 1 : 2022 Agricultural grain driers - Determination of drying performance-Part1:General FAD 20
4 IS 17791 : Part 2 : 2022 Protective equipment for martial arts: Part 2: Additional requirements and test methods for instep protectors shin protectors and forearm protectors PGD 41
5 IS 17791 : Part 4 : 2022 Protective equipment for martial arts: Part 4: Additional requirements and test methods for head protectors PGD 41
6 IS 582 : Part 9 : 2022 METHODS OF CHEMICAL TESTING OF LEATHER Part 9 Determination of pH and difference figure CHD 17
7 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
8 IS 13450 : Part 1 : Sec 11 : 2020 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 11 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment MHD 15
9 IS 13450 : Part 1 : Sec 11 : 2020 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 11 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment MHD 15
10 IS 13450 : Part 1 : Sec 11 : 2020 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 11 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment MHD 15
11 IS 13450 : Part 1 : Sec 11 : 2020 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 11 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment MHD 15
12 IS 13450 : Part 1 : Sec 11 : 2020 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 11 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment MHD 15
13 IS 13450 : Part 1 : Sec 11 : 2020 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 11 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment MHD 15