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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS/IEC 62366-1 : 2015
IEC 62366-1 : 2015 â€˜

IS Title/आईएस शीर्षक : Medical Devices Part 1 Application of Usability Engineering to Medical Devices (Withdrawn)

Superseded by IS/प्रतिस्थापित आईएस : IS 17922 (Part 1) : 2023/IEC 62366-1 : 2015 + AMD 1 : 2020

Degree of Equivalence/समतुल्यता स्तर : Identical under single numbering

Number of Revisions/पुनरीक्षणों की संख्या : New Standard

Number of Amendments/संशोधनों की संख्या : No amendment issued

Aspect/पक्ष : Code of Practice

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 14 (Hospital Planning Sectional Committee)

Member Secretary/सदस्य सचिव : Mr. VINIT VIDYADHAR BANSOD (SCIENTIST-C)

Other Details

Gazette Document : 2

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Classification details for: IS/IEC 62366 : Part 1 : 2015

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Cross Reference Details

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Cross Reference Details

Indian Standards Referred In IS IS/IEC 62366-1 : 2015
IEC 62366-1 : 2015 â€˜
:

1	IS/ISO 14971 : 2019 ISO 14971:2019	Medical devices - Application of risk management to medical devices	MHD 14

International Standards Referred In IS/IEC 62366-1 : 2015
IEC 62366-1 : 2015 â€˜

Standard contains no Cross Referenced International Standard.

IS/IEC 62366-1 : 2015
IEC 62366-1 : 2015 â€˜
is Referred in following Indian Standards :

1	IS/ISO 5840 : Part 3 : 2013	Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Trans-Catheter Techniques	MHD 6
2	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
3	IS 1363 : Part 1 : 2002	Hexagon Head Bolts, Screws and Nuts of Product Grade `C (Fourth Revision)	PGD 37
4	IS/ISO 8596 : 2017	Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation (First Revision)	MHD 5
5	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
6	IS 16143 : Part 6 : 2021	Hard coal and coke - Mechanical sampling : Part 6 coke - preparation of test samples (First Revision)	PCD 7
7	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
8	IS 17754 : Part 1 : 2022	Agricultural grain driers - Determination of drying performance-Part1:General	FAD 20
9	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
10	IS 17791 : Part 4 : 2022	Protective equipment for martial arts: Part 4: Additional requirements and test methods for head protectors	PGD 41
11	IS 582 : Part 9 : 2022	METHODS OF CHEMICAL TESTING OF LEATHER Part 9 Determination of pH and difference figure	CHD 17
12	IS 1885 : Part 84 : 2022	Electrotechnical Vocabulary Part 84 Terminology Concerning Fire Tests for Electrotechnical Products (Third Revision)	LITD 1

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Health care facilities
Sub Sub Group	:	Hospital Planning
Aspect	:	Code of Practice
Certification	:	Voluntary Certification
Relevant Ministries	:	Ministry of Health and Family Welfare
Sustainable development Goals :
Short Commom Man's Title	:
ITC-HS Code	:	N/A
Degree of Equivalence	:	Identical under single numbering
Identical/Equivalent International Standard(s)	:	IEC 62366-1:2015
Harmonized with	:

ID	Mailing list	Download
1	Committee members email list	Download
3	Additional mailing list	Download

List of Licenses under IS : IS/IEC 62366 : Part 1 : 2015

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

Gazette Document : 2

Classification details for: IS/IEC 62366 : Part 1 : 2015

Cross Reference Details

Cross Reference Details

Classification Details

Email Ids

List of Licenses under IS : IS/IEC 62366 : Part 1 : 2015

List of Expired or Cancelled Licenses under IS : IS/IEC 62366 : Part 1 : 2015

List of laboratories for : IS/IEC 62366 : Part 1 : 2015

List of Amendement(s) for : IS/IEC 62366 : Part 1 : 2015

List of Gazette Document(s) for : IS/IEC 62366 : Part 1 : 2015

List of Corigenda Document(s) for : IS/IEC 62366 : Part 1 : 2015

List of Product Manuals & SIT