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Basic Details/ मूल ब्यौरा

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

IS Title/आईएस शीर्षक : 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)

Superseding IS/सुपरसीडिंग आईएस : IS 13450 : Part 1 : Sec 11 : 2020

Degree of Equivalence/समतुल्यता स्तर : Modified/Technically Equivalent

Number of Revisions/पुनरीक्षणों की संख्या : 1

Number of Amendments/संशोधनों की संख्या : No amendment issued

Aspect/पक्ष : Others

Language/भाषा : English

Reaffirmation Year/पुनर्पुष्टि वर्ष : No reaffirmation

Technical Department/तकनीकी विभाग : MHD (Medical Equipment and Hospital Planning Department)

Technical Committee/तकनीकी समिति : MHD 15 (Electromedical, Diagnostic Imaging and Radiotherapy Equipment Sectional Committee)

Member Secretary/सदस्य सचिव : Ms. GURPREET KAUR BHOMBRA (SCIENTIST-C)

Other Details

Indian Standard

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Amendment : 0

Gazette Document : 6

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License : 0

Product Manual & SIT : 0

Laboratory : 0

Classification Details

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Cross Reference Details

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Composition

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Corrigendum : 0

Cross Reference Details

Indian Standards Referred In IS IS 13450 (Part 1/Sec 11) : 2024
:

1	IS 9000 (Part 7/Sec 1) : 2018 IEC 60068-2-27 : 2008 Reviewed In : 2021	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 IEC 60068-2-31 : 2008 Reviewed In : 2022	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 15223-1 : 2016 ISO 15223-1 : 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 Reviewed In : 2023	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 Reviewed In : 2022	Concentrated solar thermal - Specification: Part 1 paraboloid dish concentrator	MED 4
9	IS/ISO 10993-10 : 2010 ISO 10993-10 : 2010	Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization	MHD 19
10	IS/ISO 10993-15 : 2000 ISO 10993-15 : 2000	Biological evaluation of medical devices: Part 15 identification and quantification of degradation products from metals and alloys	MHD 19
11	IS/IEC 60884-2- 5 : 1995 IEC 60884-2-5 : 1995 Reviewed In : 2024	Plugs and Socket-Outlets for Household and Similar Purposes Part 2 Particular Requirements DSection 5 Adaptors	ETD 14

International Standards Referred In IS 13450 (Part 1/Sec 11) : 2024

1	IEC 60068 : 2 : 64 2008
2	IEC 60529 : 2013

IS 13450 (Part 1/Sec 11) : 2024
is Referred in following Indian Standards :

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

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Diagnostic Instruments
Sub Sub Group	:	Surgical, Diagnostic equipment and General safety requirements
Aspect	:	Others
Certification	:	Not Certifiable
Relevant Ministries	:	Ministry of Health and Family Welfare
Sustainable development Goals :
Short Commom Man's Title	:
ITC-HS Code	:
Degree of Equivalence	:	Modified/Technically Equivalent
Identical/Equivalent International Standard(s)	:	IEC 60601-1-11:2020
Harmonized with	:	IEC

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1	Committee members email list	Download
3	Additional mailing list	Download

List of Licenses under IS : IS 13450 : Part 1 : Sec 11 : 2024

ID	Licence No.	Firm Name & Address	District	State	Validity Date	Status	Variety	Brand Name	Scale

ID	Licence No.	Firm Name & Address	District	State	Validity Date	Status	Variety	Brand Name	Scale

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Basic Details/ मूल ब्यौरा

Other Details

Indian Standard

Amendment : 0

Gazette Document : 6

License : 0

Product Manual & SIT : 0

Laboratory : 0

Classification Details

Cross Reference Details

Composition

Corrigendum : 0

Cross Reference Details

Classification Details

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List of Licenses under IS : IS 13450 : Part 1 : Sec 11 : 2024

List of Expired or Cancelled Licenses under IS : IS 13450 : Part 1 : Sec 11 : 2024

List of laboratories for : IS 13450 : Part 1 : Sec 11 : 2024

List of Amendement(s) for : IS 13450 : Part 1 : Sec 11 : 2024

List of Gazette Document(s) for : IS 13450 : Part 1 : Sec 11 : 2024

List of Corigenda Document(s) for : IS 13450 : Part 1 : Sec 11 : 2024

List of Product Manuals & SIT