Indian_standards - BIS Connect

Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS/ISO 14971 : 2019
ISO 14971:2019

IS Title/आईएस शीर्षक : Medical devices - Application of risk management to medical devices First Revision

Superseding IS/सुपरसीडिंग आईएस : None

Degree of Equivalence/समतुल्यता स्तर : Identical under single numbering

Number of Revisions/पुनरीक्षणों की संख्या : 1

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

Indian Standard

Click to download

Amendment : 0

Gazette Document : 4

Click to download

License : 0

Product Manual & SIT : 0

Laboratory : 0

Classification Details

Click to view

Cross Reference Details

Click to view

Composition

Click to View

Corrigendum : 0

Cross Reference Details

Indian Standards Referred In IS IS/ISO 14971 : 2019
ISO 14971:2019
:

Standard contains no Cross Referenced Indian Standard.
Standard contains no Cross Referenced Indian Standard.

International Standards Referred In IS/ISO 14971 : 2019
ISO 14971:2019

1	0 0 : 0 : 0 0

IS/ISO 14971 : 2019
ISO 14971:2019
is Referred in following Indian Standards :

1	IS/ISO 25539 : Part 1 : 2017	Cardiovascular implants - Endovascular devices: Part 1 endovascular prostheses (First Revision)	MHD 6
2	IS/ISO 12417 : Part 1 : 2015	Cardiovascular Implants and Extracorporeal Systems Vascular Device-Drug Combination Products Part 1 General Requirements	MHD 6
3	IS/ISO/TS 22367 : 2008	Medical Laboratories - Reduction of Error through Risk Management and Continual Improvement	MHD 14
4	IS/IEC 62366 : Part 1 : 2015	Medical Devices Part 1 Application of Usability Engineering to Medical Devices	MHD 14
5	IS/IEC/TR 62366 : Part 2 : 2016	Medical devices Part 2 Guidance on the Application of Usability Engineering to Medical Devices	MHD 14
6	IS/ISO 15198 : 2004	Clinical Laboratory Medicine - In vitro Diagnostic Medical Devices - Validation of User Quality Control Procedures by the Manufacturer	MHD 19
7	IS/ISO 5840 : Part 2 : 2015	Cardiovascular Implants Cardiac Valve Prostheses Part 2 Surgically Implanted Heart Valve Substitutes	MHD 6
8	IS/ISO 5840 : Part 3 : 2013	Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Trans-Catheter Techniques	MHD 6
9	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
10	IS/ISO 14971 : 2007	Medical devices - Application of risk management to medical devices	MHD 14
11	IS/ISO 80601 : Part 2 : Sec 12 : 2011	MEDICAL ELECTRICAL EQUIPMENT PART 2-12 PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS	MHD 15
12	IS 12725 : 2021	Pneumatic Fluid Power - General Rules and Safety Requirements for Systems and their Components ( Second Revision )	PGD 36
13	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
14	IS/ISO 10524 : Part 3 : 2005	Pressure regulators for use with medical gases: Part 3 pressure regulators integrated with cylinder valves	MHD 11
15	IS/ISO 27427 : 2013	Anaesthetic and Respiratory Equipment - Nebulizing Systems and Components	MHD 11
16	IS 16693 : 2021	Reference sources - Calibration of surface contamination monitors - Alpha beta and photon emitters (First Revision)	CHD 30
17	IS 10258 : Part 3 : 2010	Sterile hypodermic syringes for single use: Part 3 auto - Disable syringes for fixed - Dose immunization	MHD 12
18	IS 17545 : 2021	White cement based polymeric putty	CHD 20
19	IS/ISO 6722 : Part 1 : 2011	Road vehicles -- 60 V and 600 V single-core cables -- Part 1: Dimensions test methods and requirements for copper conductor cables	TED 11
20	IS 14147 : Part 1 : 2021	Identification Cards Recording Technique Part 1 Embossing	LITD 16
21	IS/ISO 11197 : 2016	Medical supply units	MHD 11
22	IS 1060 : Part 5 : Sec 12 : 2021	Method of Sampling and Test for Paper and Allied Products Part 5 Method of Test for Paper and Board Section 12 Measurement of specular gloss 75 degree gloss with a converging beam TAPPI method	CHD 15
23	IS 229 : 2021	Ethyl acetate - Specification (Fourth Revision)	PCD 9
24	IS 15748 : 2022	Protective clothing - Clothing to protect against heat and flame - Minimum performance requirements (first revision)	TXD 32
25	IS 11563 : 2022	TECHNICAL SUPPLY CONDITIONS FOR DYNAMIC COMPRESSORS	MED 22

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Health care facilities
Sub Sub Group	:	Quality Management of hospitals
Aspect	:	Code of Practice
Certification	:	Voluntary Certification
Relevant Ministries	:	Ministry of Consumer Affairs, Food and Public Distribution - Department of Food and Public Distribution
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)	:	ISO 14971 : 2019
Harmonized with	:	ISO

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

List of Licenses under IS : IS/ISO 14971 : 2019

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 : 4

License : 0

Product Manual & SIT : 0

Laboratory : 0

Classification Details

Cross Reference Details

Composition

Corrigendum : 0

Cross Reference Details

Classification Details

Email Ids

List of Licenses under IS : IS/ISO 14971 : 2019

List of Expired or Cancelled Licenses under IS : IS/ISO 14971 : 2019

List of laboratories for : IS/ISO 14971 : 2019

List of Amendement(s) for : IS/ISO 14971 : 2019

List of Gazette Document(s) for : IS/ISO 14971 : 2019

List of Corigenda Document(s) for : IS/ISO 14971 : 2019

List of Product Manuals & SIT