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Basic Details/ मूल ब्यौरा

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

IS Title/आईएस शीर्षक : Medical electrical equipment Part 1 General requirements for basic safety and essential performance (Third Revision)

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

Degree of Equivalence/समतुल्यता स्तर : Modified/Technically Equivalent

Number of Revisions/पुनरीक्षणों की संख्या : 3

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) : 2024
:

1	IS 616 : 2017 IEC 60065 : 2014 Reviewed In : 2023	Audio, video and similar electronic apparatus - Safety requirements (Fifth Revision)	LITD 7
2	IS/IEC 60079-0 : 2017 IEC 60079-0 : 2017	Explosive Atmospheres Part 0 Equipment — General Requirements ( Third Revision )	ETD 22
3	IS/IEC 60079-2 : 2014 IEC 60079-2 : 2014 Reviewed In : 2022	Explosive atmospheres: Part 2 equipment protection by pressurized enclosure ''p'' (First Revision)	ETD 22
4	IS/IEC 60079-5 : 2015 IEC 60079-5:2015+AMD1:2022	Explosive atmospheres: Part 5 equipment protection by powder filling ''q'' (First Revision)	ETD 22
5	IS/IEC 60079 Part 6 : 2020	Explosive atmospheres - Part 6: Equipment protection by liquid immersion "o" (Second Revision)	ETD 22
6	IS 1271 : 2012 IEC 60085 Reviewed In : 2024	Electrical insulation - Thermal evaluation and designation (Second Revision)	ETD 2
7	IS 6303 (Part 4) : 2023 60086-4 : 2019	Primary batteries: Part 4 safety of lithium batteries (Second Revision)	ETD 10
8	IS/IEC 60127-1 : 2006 Reviewed In : 2024	Miniature fuses: Part 1 definitions for miniature fuses and general requirements for miniature fuse - Links (First Revision)	ETD 39
9	IS/IEC 60320-1 : 2021 60320-1: 2021	Appliance couplers for household and similar general purposes: Part 1 general requirements	ETD 14
10	IS 14980 (Part 3) : 2024 ISO 8759-3:2018	Insulation Coordination for Equipment Within Low-Voltage Systems Part 1 Principles Requirements and Tests	ETD 19
11	IS 13778 (Part 3) : 2012 IEC 60851-3 Reviewed In : 2024	Winding wires - Test methods: Part 3 mechanical properties (First Revision)	ETD 33
12	IS 13778 (Part 5) : 2012 IEC 60851-5 : 2008 Reviewed In : 2024	Winding wires - Test methods: Part 5 electrical properties (First Revision)	ETD 33
13	IS 13252 (Part 1) : 2010 IEC 60950 Part 1:2005 Reviewed In : 2022	Information technology equipment - Safety: Part 1 general requirements (Second Revision)	LITD 7
14	IS 15575 (Part 1) : 2016 IEC 61672-1 Reviewed In : 2022	Electroacoustics - Sound level meters: Part 1 specifications (First Revision)	LITD 7
15	IS 16046 (Part 1) : 2018 IEC 62133-1 : 2017 Reviewed In : 2024	Secondary Cells and Batteries Containing Alkaline or Other Non-Acid Electrolytes - Safety Requirements for Portable Sealed Secondary Cells and for Batteries Made from Them for Use in Portable Applications Part 1 Nickel Systems ( Second Revision )	ETD 11
16	IS 16046 (Part 2) : 2018 IEC 62133-2 : 2017 Reviewed In : 2024	Secondary Cells and Batteries Containing Alkaline or Other Non-Acid Electrolytes - Safety Requirements for Portable Sealed Secondary Cells and for Batteries Made from Them for Use in Portable Applications Part 2 Lithium Systems ( Second Revision )	ETD 11
17	IS/ISO 62304 : 2015 ISO 62304 : 2015	Medical device software - Software life cycle processes	MHD 14
18	IS/IEC 62368-1 : 2018 IEC 62368-1 : 2018 Reviewed In : 2023	Audio / Video, Information and Communication Technology Equipment Part 1 Safety Requirements ( First Revision )	LITD 7
19	IS 1260 (Part 2) : 2020	Packaging — Distribution Packaging — Graphical Symbols for Handling and Storage of Packages Part 2 General Goods ( Fourth Revision )	TED 24
20	IS 16449 (Part 1) : 2018 Reviewed In : 2024	Graphical symbols - Safety colours and safety signs: Part 1 design principles for safety signs and safety markings	PGD 1
21	IS/ISO 5349-1 : 2001 Reviewed In : 2022	Mechanical vibration - Measurement and evaluation of human exposure to handtransmitted vibration: Part 1 general requirements (First Revision)	MED 28
22	IS 16450 : 2023	Graphical Symbols for Use on Equipment Registered Symbols	PGD 1
23	IS 16451 : 2023	Graphical Symbols Safety Colours and Safety Signs Registered Safety Signs	PGD 1
24	IS/ISO 11137-1 : 2006 ISO 11137-1 : 2006	Sterilization of health care products - Radiation: Part 1 requirements for development, validation and routine control of a sterilization process for medical devices	MHD 12
25	IS/IEC 60143-1 : 2015 IEC 60143-1:2015	SAFETY OF MACHINERY SAFETY DISTANCES TO PREVENT HAZARD ZONES BEING REACHED BY UPPER AND LOWER LIMBS	MED 40
26	IS 17781 : 2021	Medical devices - Application of risk management to medical devices First Revision	MHD 14
27	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
28	IS 17559 (Part 2) : 2021 ISO 6657 (Part-2) :	Rubber - General Procedures for Preparing and Conditioning Test Pieces for Physical Test Methods ( First Revision )	PCD 29
29	IS/ISO 80000 : Part 1 : 2022	Quantities and Units Part 1 General	PGD 1
30	IS 16621 : 2017	Positive list of constituents of polyethylene and polypropylene in contact with foodstuffs, pharmaceuticals and drinking water	PCD 12
31	IS 16648 (Part 1) : 2017 Reviewed In : 2022	Concentrated solar thermal - Specification: Part 1 paraboloid dish concentrator	MED 4
32	IS/ISO 10993-10 : 2010 ISO 10993-10 : 2010	Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization	MHD 19
33	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

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

1	IEC 60068 : 2 : 2 2007
2	IEC 60384 : 14 : 2023
3	IEC 60417 : 2019
4	IEC 60445 : 2021
5	IEC 60529 : 2013
6	IEC 60730 : 1 : 2010
7	IEC 60447 : 2004
8	IEC 60747 : 5 : 5 2022
9	IEC 60825 : 1 : 2014
10	IEC 60851 : 6 : 2012
11	IEC 1853 : 2018
12	ISO 2878 : 2017
13	ISO 2882 : 1979
14	ISO 3746 : 2010
15	ISO 9614 : 1 : 1993
16	ISO 11135 : 0 : 0 0

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

1	IS 14679 : 1999	Neurosurgical implants - Implantable peripheral nerve stimulators	MHD 7
2	IS 11364 : 1994	Anaesthetic Reservoir Bags	MHD 11
3	IS 7409 : Part 1 : 2003	Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1 : Cones and Sockets	MHD 11
4	IS 11754 : 1986	Implantable Ventricular Pacemaker	MHD 15
5	IS 11661 : 1986	Safety of Lung Ventilator for Medical Use	MHD 15
6	IS 13523 : Part 1 : 1992	Medical Electrical Equipment - Shortwave Therapy Equipment: Part 1 General And Safety Requirements	MHD 15
7	IS 13523 : Part 2 : 1992	Medical Electrical Equipment - Shortwave Therapy Equipment: Part 2 Performance Requirements	MHD 15
8	IS/ISO 14708 : Part 3 : 2017	Implants for surgery - Active implantable medical devices: Part 3 implantable neurostimulators (First Revision)	MHD 7
9	IS/IEC 60645 : Part 1 : 2017	Electroacoustics - Audiometric equipment: Part 1 equipment for pure - Tone and speech audiometry	LITD 7
10	IS/IEC 60645 : Part 7 : 2009	Electroacoustics - Audiometric equipment: Part 7 instruments for the measurement of auditory brainstem responses	LITD 7
11	IS/ISO 14708 : Part 1 : 2014	Implants for surgery - Active implantable medical devices: Part 1 general requirements for safety, marking and for information to be provided by the manufacturer (First Revision)	MHD 7
12	IS/ISO 22523 : 2006	External limb prostheses and external orthoses - Requirements and test methods	MHD 9
13	IS/IEC 61204 : Part 3 : 2016	Low-Voltage Switch Mode Power Supplies Part 3 Electromagnetic Compatibility ( EMC )	ETD 31
14	IS 13450 : Part 2 : Sec 68 : 2020	Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 68 X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment	MHD 15
15	IS 13450 : Part 4 : Sec 1 : 2020	Medical electrical equipment: Part 4 Guidance and interpretation: Section 1 Medical electrical equipment and medical electrical systems employing a degree of autonomy	PGD 18
16	IS 15500 : PART 8 : 2004	DEEPWELL HANDPUMPS, COMPONENTS AND SPECIAL TOOLS SPECIFICATION PART 8 SPECIAL TOOLS	MED 27
17	IS/IEC 61217 : 2011	Radiotherapy Equipment - Coordinates, Movements and Scales	MHD 15
18	IS 14423 : 2021	Fluid Power Systems and Components - Connectors and Associated Components - Nominal Pressures ( First Revision )	PGD 36
19	IS 17426 : 2020	ICU Ventilators for use in COVID-19 - Specification	MHD 11
20	IS/ISO 10524 : Part 3 : 2005	Pressure regulators for use with medical gases: Part 3 pressure regulators integrated with cylinder valves	MHD 11
21	IS/ISO 27427 : 2013	Anaesthetic and Respiratory Equipment - Nebulizing Systems and Components	MHD 11
22	IS/IEC 60071 : Part 1 : 2006	Insulation Co-ordination Part 1 Definitions, Principles and Rules	ETD 19
23	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
24	IS/ISO 8596 : 2017	Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation (First Revision)	MHD 5
25	IS 16693 : 2021	Reference sources - Calibration of surface contamination monitors - Alpha beta and photon emitters (First Revision)	CHD 30
26	IS 13450 : Part 2 : Sec 22 : 2019	Medical electrical equipment: Part 2 particular requirements for basic safety and essential performance: Sec 22 surgical, cosmetic, therapeutic and diagnostic laser equipment	MHD 15
27	IS 13450 : Part 2 : Sec 31 : 2019	Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 31 external cardiac pacemakers with internal power source	MHD 15
28	IS 398 : Part 6 : 2021	Aluminium Conductors for Overhead Transmission Purposes Part 6 High Conductivity Aluminium Alloy Stranded Conductors — Specification	ETD 37
29	IS 548 : Part 3 : Sec 7 : 2021	METHODS OF SAMPLING AND TEST FOR OILS AND FATS PART 3 ADVANCED INSTRUMENTAL METHODS SECTION 7 DETERMINATION OF PHOSPHORUS CONTENT BY GRAPHITE FURNACE ATOMIC ABSORPTION SPECTROMETRIC METHOD (Adoption of ISO 10540-2 : 2003)	FAD 13
30	IS 5402 : Part 1 : 2021	Microbiology of the food chain - Horizontal method for the enumeration of microorganisms- Part 1: Colony count at 30 C by the pour plate technique	FAD 31
31	IS/ISO 5971 : 2017	Textiles Size designation of clothes Tights	TXD 20
32	IS/ISO 80601 : Part 2 : Sec 61 : 2011	Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 61 pulse oximeter equipment	MHD 15
33	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
34	IS/ISO 11197 : 2016	Medical supply units	MHD 11
35	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
36	IS/ISO 2408 : 2017	Steel wire ropes Requirements	MED 10
37	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
38	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
39	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
40	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
41	IS 2032 : Part 19 : 1977	Graphical symbols used in electrotechnology: Part 19 electrical equipment used in medical practice	ETD 1
42	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
43	IS 17791 : Part 4 : 2022	Protective equipment for martial arts: Part 4: Additional requirements and test methods for head protectors	PGD 41
44	IS 582 : Part 9 : 2022	METHODS OF CHEMICAL TESTING OF LEATHER Part 9 Determination of pH and difference figure	CHD 17
45	IS 582 : Part 13 : 2022	METHODS OF CHEMICAL TESTING OF LEATHER Part 13 Determination of total silicon content Reduced molybdosilicate spectrometric method	CHD 17
46	IS 582 : Part 14 : 2022	METHODS OF CHEMICAL TESTING OF LEATHER Part 14 DETERMINATION OF MATTER SOLUBLE IN DICHLOROMETHANE AND FREE FATTY ACID CONTENT	CHD 17
47	IS 11852 : 2013	Automotive Vehicles - Uniform Provisions Concerning the Approval of Vehicles of Categories M, N and T with Regard to Braking	TED 4
48	IS/IEC 61557 : Part 1 : 2019	Electrical Safety in Low Voltage Distribution Systems Up to 1 000 V a.c. and 1 500 V d.c. - Equipment for Testing, Measuring or Monitoring of Protective Measures Part 1 General Requirements ( First Revision )	ETD 12
49	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
50	IS 3025 : Part 17 : 2022	Methods of Sampling and Test (Physical and Chemical) for Water and Wastewater Part 17 Non- Filterable Residue Total Suspended Solids at 103 C - 105 C (Second Revision)	CHD 36
51	IS 3160 : 2022	Tur Chuni as Livestock Feed Ingredient ï¿½ Specification	FAD 5
52	IS 3161 : 2022	Gram Chuni as Livestock Feed Ingredient ï¿½ Specification	FAD 5
53	IS 14794 : 2022	ISOBUTENE-ISOPRENE RUBBER IIR EVALUATION PROCEDURES Third Revision	PCD 29
54	IS 13450 : Part 1 : 2018	Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision)	MHD 15
55	IS 13450 : Part 1 : 2018	Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision)	MHD 15
56	IS 13450 : Part 1 : 2018	Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision)	MHD 15
57	IS 13450 : Part 1 : 2018	Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision)	MHD 15
58	IS 18098 : 2022	Ashvagandha Withania somnifera L Dunal root Specifications for use in Traditional Medicine	AYD 1
59	IS 11055 : 2022	TEXTILES COTTON BLUE AIRMAIL BAGS SPECIFICATION	TXD 20
60	IS/IEC 62680 : Part 1 : Sec 8 : 2019	Universal serial bus interfaces for data and power Part 1-8: Common components USB Audio 30 device class definition terminal types	LITD 7
61	IS 4155 : 2023	Glossary of Terms Relating to Chemical and Radiation Hazards and Hazardous Chemicals (First Revision)	CHD 7
62	IS 4079 : 2023	PACKED RASOGOLLA ï¿½ SPECIFICATION (First Revision of IS 4079)	FAD 19

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 60601-1:2020
Harmonized with	:	IEC

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List of Licenses under IS : IS 13450 : Part 1 : 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

Know your standards

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 : 2024

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

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

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

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

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

List of Product Manuals & SIT