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IS Number/आईएस संख्या : IS 13450 (Part 1/Sec 2) : 2024

IS Title/आईएस शीर्षक : Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 2 Electromagnetic disturbances Requirements and tests (Second Revision)

Superseding IS/सुपरसीडिंग आईएस : IS 13450 : Part 1 : SEC 2 : 2018

Degree of Equivalence/समतुल्यता स्तर : Modified/Technically Equivalent

Number of Revisions/पुनरीक्षणों की संख्या : 2

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 2) : 2024
:

1	IS 14700 (Part 4/Sec 2) : 2018 61000-4-2 : 2008 Reviewed In : 2024	Electromagnetic compatibility (EMC): Part 4 testing and measurement techniques: Sec 2 electrostatic discharge immunity test (Second Revision)	LITD 9
2	IS 14700 (Part 4/Sec 6) : 2016 IEC 61000-4-6 : 2013 Reviewed In : 2022	Electromagnetic compatibility (EMC): Part 4 testing and measurement techniques: Sec 6 immunity to conducted disturbances, induced by radio - Frequency fields	LITD 9
3	IS 14700 (Part 4/Sec 8) : 2018 IEC 61000-4-8 : 2009 Reviewed In : 2024	Electromagnetic compatibility (EMC): Part 4 testing and measurement techniques: Sec 8 power frequency magnetic field immunity test (Second Revision)	LITD 9
4	IS 17792 : 2022	Electromagnetic compatibility EMC: Part 4 testing and measurement techniques: Sec 11 voltage dips short interruptions and voltage variations immunity tests for equipment with input current up to 16 A per phase	LITD 9
5	IS 17858 : 2022 ISO 1763 : 2020	Limits and methods of measurements of radio disturbance characteristics Part 2 Electro Magnetic Compatibility (EMC) â€“ Requirements for Household Appliances, Electric tools and similar apparatus, Section 1 Emission	LITD 9
6	IS/CISPR 32 : 2015 CISPR 32 : 2015 Reviewed In : 2022	Electromagnetic Compatibility of Multimedia Equipment Emission Requirements	LITD 9
7	IS 17781 : 2021	Medical devices - Application of risk management to medical devices First Revision	MHD 14
8	IS 16483 : 2017 Reviewed In : 2023	Geosynthetics - Method for microscopic evaluation of the dispersion of carbon black in polyolefin geosynthetics	TXD 30
9	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
10	IS/ISO 18431-1 : 2005 ISO 18431-1 : 2005 Reviewed In : 2019	Mechanical vibration and shock - Signal processing: Part 1 general introduction	MED 28
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
12	IS 16205 (Part 21) : 2017	Conduit Systems for Cable Management Part 21 Particular Requirements Rigid Conduit Systems	ETD 14
13	IS 16205 (Part 22) : 2017	Conduit Systems for Cable Management Part 22 Particular Requirements - Pilable Conduit Systems	ETD 14

International Standards Referred In IS 13450 (Part 1/Sec 2) : 2024

1	IEC 61000 : 3 : 2 2020
2	IEC 61000 : 3 : 3 2021
3	IEC 61000 : 4 : 3 2020
4	IEC 61000 : 4 : 4 2012
5	IEC 61000 : 4 : 5 2017
6	IEC 61000 : 4 : 39 2017
7	ISO 7637 : 2 : 2011

IS 13450 (Part 1/Sec 2) : 2024
is Referred in following Indian Standards :

1	IS 14700 : Part 4 : Sec 1 : 2019	Electromagnetic compatibility (EMC): Part 4 testing and measurement techniques: Sec 1 overview of the IEC 61000 - 4 series (Second Revision)	LITD 9
2	IS/ISO 22523 : 2006	External limb prostheses and external orthoses - Requirements and test methods	MHD 9
3	IS 13450 : Part 2 : Sec 34 : 2019	Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 34 Invasive blood pressure monitoring equipment	MHD 15
4	IS 15040 : 2020	Radio Disturbance Characteristics for Protection of Receivers used on Board Vehicles, Boats and Internal Combustion Engines — Limits and Methods of Measurement ( Second Revision )	LITD 9
5	IS 13450 : Part 2 : Sec 46 : 2020	Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 46 Operating tables	MHD 15
6	IS/IEC 80601 : Part 2 : Sec 35 : 2009	Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 35 Heating devices using blankets, pads or mattresses and intended for heating in medical use	MHD 15
7	IS 17426 : 2020	ICU Ventilators for use in COVID-19 - Specification	MHD 11
8	IS 6873 : Part 4 : 1999	Limits and Methods of Measurement of Radio Disturbance Characteristics - Part 4 : Industrial, Scientific and Medical (ISM) Radio-frequency Equipment	LITD 9
9	IS/ISO 27427 : 2013	Anaesthetic and Respiratory Equipment - Nebulizing Systems and Components	MHD 11
10	IS 1180 : Part 3 : 2021	Outdoor/Indoor Type Liquid Immersed Distribution Transformers Up to and Including 2 500 kVA, 33 kV — Specification Part 3 Natural/Synthetic Organic Ester Liquid Immersed	ETD 16
11	IS/ISO 8596 : 2017	Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation (First Revision)	MHD 5
12	IS/IEC 60479 : Part 1 : 2018	Effects of current on human beings and livestock - Part 1: General Aspects	ETD 20
13	IS 398 : Part 6 : 2021	Aluminium Conductors for Overhead Transmission Purposes Part 6 High Conductivity Aluminium Alloy Stranded Conductors — Specification	ETD 37
14	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
15	IS 5815 : Part 2 : 2021	Textiles - Fishing gear materials - Methods of test Part 2: Determination of linear density mass per unit length (first revision)	TXD 18
16	IS 13450 : Part 2 : Sec 19 : 2018	Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 19 baby incubator	MHD 15
17	IS 13450 : Part 2 : Sec 20 : 2018	Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 20 infant transport incubators	MHD 15
18	IS 13450 : Part 2 : Sec 21 : 2018	Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 21 infant radiant warmer	MHD 15
19	IS 17614 : Part 20 : 2021	Water Quality Sampling Part 20 Guidance on the Use of Sampling Data for Decision Making Compliance with Thresholds and Classification Systems	CHD 36
20	IS 17791 : Part 4 : 2022	Protective equipment for martial arts: Part 4: Additional requirements and test methods for head protectors	PGD 41
21	IS 582 : Part 9 : 2022	METHODS OF CHEMICAL TESTING OF LEATHER Part 9 Determination of pH and difference figure	CHD 17
22	IS 11852 : 2013	Automotive Vehicles - Uniform Provisions Concerning the Approval of Vehicles of Categories M, N and T with Regard to Braking	TED 4
23	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
24	IS 17881 : Part 1 : 2022	Protective clothing against heat and flame - Part 1 Test method for complete garments - Measurement of transferred energy using an instrumented manikin	TXD 32
25	IS 3161 : 2022	Gram Chuni as Livestock Feed Ingredient ï¿½ Specification	FAD 5
26	IS 13450 : Part 1 : SEC 2 : 2018	Medical electrical equipment: Part 1 general requirements for the basic safety and essential performance: Sec 2 collateral standard: electromagnetic disturbances - Requirements and tests (First Revision)	MHD 15
27	IS 13450 : Part 1 : SEC 2 : 2018	Medical electrical equipment: Part 1 general requirements for the basic safety and essential performance: Sec 2 collateral standard: electromagnetic disturbances - Requirements and tests (First Revision)	MHD 15
28	IS 13450 : Part 1 : SEC 2 : 2018	Medical electrical equipment: Part 1 general requirements for the basic safety and essential performance: Sec 2 collateral standard: electromagnetic disturbances - Requirements and tests (First Revision)	MHD 15
29	IS 13450 : Part 1 : SEC 2 : 2018	Medical electrical equipment: Part 1 general requirements for the basic safety and essential performance: Sec 2 collateral standard: electromagnetic disturbances - Requirements and tests (First Revision)	MHD 15
30	IS 13450 : Part 1 : SEC 2 : 2018	Medical electrical equipment: Part 1 general requirements for the basic safety and essential performance: Sec 2 collateral standard: electromagnetic disturbances - Requirements and tests (First Revision)	MHD 15
31	IS 13450 : Part 1 : SEC 2 : 2018	Medical electrical equipment: Part 1 general requirements for the basic safety and essential performance: Sec 2 collateral standard: electromagnetic disturbances - Requirements and tests (First Revision)	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 60601-1-2:2020
Harmonized with	:	IEC

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List of Licenses under IS : IS 13450 : Part 1 : SEC 2 : 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 2 : 2024

List of Expired or Cancelled Licenses under IS : IS 13450 : Part 1 : SEC 2 : 2024

List of laboratories for : IS 13450 : Part 1 : SEC 2 : 2024

List of Amendement(s) for : IS 13450 : Part 1 : SEC 2 : 2024

List of Gazette Document(s) for : IS 13450 : Part 1 : SEC 2 : 2024

List of Corigenda Document(s) for : IS 13450 : Part 1 : SEC 2 : 2024

List of Product Manuals & SIT