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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS/ISO 13485 : 2016

IS Title/आईएस शीर्षक : Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision )

Superseding IS/सुपरसीडिंग आईएस : ISO 13485 : 2016

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 : System Standard

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

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Amendment : 0

Gazette Document : 1

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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/ISO 13485 : 2016

:

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

International Standards Referred In IS/ISO 13485 : 2016

1	0 0 : 0 : 0 0
2	ISO 9000 : 2015
3	ISO 9000 : 2015
4	ISO 0 : 0 : 0 0
5	ISO 9000 : 2015
6	ISO 9000 : 2015
7	ISO 0 : 0 : 0 0
8	ISO 9000 : 2015
9	ISO 9000 : 2015
10	ISO 15000 : 2015
11	ISO 0 : 0 : 0 0
12	ISO 9000 : 2015
13	ISO 0 : 0 : 0 0

IS/ISO 13485 : 2016

is Referred in following Indian Standards :

1	IS/ISO 13022 : 2012	Medical products containing viable human cells - Application of risk management and requirements for processing practices	MHD 19
2	IS/ISO 25539 : Part 1 : 2017	Cardiovascular implants - Endovascular devices: Part 1 endovascular prostheses (First Revision)	MHD 6
3	IS/ISO 11137 : Part 3 : 2017	Sterilization of Health Care Products â€• Radiation Part 3 Guidance on Dosimetric Aspects of Development, Validation and Routine Control	MHD 12
4	IS/ISO 13485 : 2016	Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision )	MHD 14
5	IS/ISO 15198 : 2004	Clinical Laboratory Medicine - In vitro Diagnostic Medical Devices - Validation of User Quality Control Procedures by the Manufacturer	MHD 19
6	IS 3565 : 1966	Rubber Teats for Feeding Bottles	PCD 13
7	IS/ISO 6016 : 2008	Earth-Moving Machinery â€” Methods of Measuring the Masses of Whole Machines, their Equipment and Components	MED 7
8	IS 16143 : Part 6 : 2021	Hard coal and coke - Mechanical sampling : Part 6 coke - preparation of test samples (First Revision)	PCD 7
9	IS 17652 : 2021	Soy Butter	FAD 16
10	IS 17591 : 2021	Guideline for the system design of HVDC converter stations with line-commutated converters	ETD 40
11	IS 16048 : Part 2 : 2021	SECONDARY CELLS AND BATTERIES CONTAINING ALKALINE OR OTHER NON-ACID ELECTROLYTES SECONDARY SEALED CELLS AND BATTERIES FOR PORTABLE APPLICATIONS PART 2: NICKEL-METAL HYDRIDE	ETD 11
12	IS 729 : 2021	DRAWER LOCKS CUPBOARD LOCKS AND BOX LOCKS - SPECIFICATION	MED 33
13	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
14	IS 14473 : Part 3 : 2022	CRANES INSPECTIONS -- PART 3 TOWER CRANES	MED 14
15	IS 15748 : 2022	Protective clothing - Clothing to protect against heat and flame - Minimum performance requirements (first revision)	TXD 32
16	IS 17847 : 2022	Bensulfuron Methyl technical- Specification	FAD 1
17	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
18	IS 1885 : Part 84 : 2022	Electrotechnical Vocabulary Part 84 Terminology Concerning Fire Tests for Electrotechnical Products (Third Revision)	LITD 1
19	IS 3025 : Part 18 : 2022	Methods of Sampling and Test (Physical and Chemical) for Water and Wastewater Part 18 Volatile and Fixed Solids (Total, Filterable and Non-Filterable at 550 C (Second Revision)	CHD 36
20	IS 11047 : 2022	TEXTILES POSTAL GREEN CASH BAGS SPECIFICATION	TXD 20
21	IS 17883 : 2022	Geological Exploration for Tunnels Guidelines	WRD 5
22	IS 17960 : 2022	Dentistry Coiled springs for use in orthodontics	MHD 8
23	IS/IEC 62488 : Part 3 : 2021	Power line communication systems for power utility applications Part 3: Digital Power Line Carrier DPLC Terminals and hybrid ADPLC Terminals	LITD 10
24	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
25	IS 16412 : 2023	Nanotechnologies Characterization of multiwall carbon nanotubes Mesoscopic shape factors	MTD 33

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Medical and Hospital Equipments
Sub Sub Group	:	Allied hospital equipment
Aspect	:	System Standard
Certification	:	Voluntary Certification
Relevant Ministries	:
Sustainable development Goals :
Short Commom Man's Title	:	Medical devices-Quality management systems- Requirements for regulatory purposes
ITC-HS Code	:
Degree of Equivalence	:	Identical under single numbering
Identical/Equivalent International Standard(s)	:	ISO 13485:2016
Harmonized with	:

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

List of Licenses under IS : IS/ISO 13485 : 2016

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 : 1

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/ISO 13485 : 2016

List of Expired or Cancelled Licenses under IS : IS/ISO 13485 : 2016

List of laboratories for : IS/ISO 13485 : 2016

List of Amendement(s) for : IS/ISO 13485 : 2016

List of Gazette Document(s) for : IS/ISO 13485 : 2016

List of Corigenda Document(s) for : IS/ISO 13485 : 2016

List of Product Manuals & SIT