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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS/ISO 10993-4 : 2017
ISO 10993-4 : 2017

IS Title/आईएस शीर्षक : Biological evaluation of medical devices Part 4 Selection of tests for interactions with blood

Superseding IS/सुपरसीडिंग आईएस : None

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 : Methods of tests

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 19 (In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices Sectional Committee)

Member Secretary/सदस्य सचिव : Ms. NAGAVARSHINI M (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 10993-4 : 2017
ISO 10993-4 : 2017
:

1	IS/IEC/TS 62351-3 : 2014 IEC 62351-3 : 2014 Reviewed In : 2019	Power Systems Management and Associated Information Exchange — Data and Communications Security Part 3 Communication Network and System Security — Profiles Including TCP/IP ( First Revision )	LITD 10

International Standards Referred In IS/ISO 10993-4 : 2017
ISO 10993-4 : 2017

1	ISO 10993 : 1 : 2009
2	ISO 0 : 0 : 0 0

IS/ISO 10993-4 : 2017
ISO 10993-4 : 2017
is Referred in following Indian Standards :

1	IS/ISO 7198 : 2016	Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches	MHD 6
2	IS/ISO 15675 : 2016	Cardiovascular Implants and Artificial Organs Cardiopulmonary Bypass Systems Arterial Blood Line Filters	MHD 6
3	IS/ISO 18241 : 2016	Cardiovascular Implants and Extracorporeal Systems Cardiopulmonary Bypass Systems Venous Bubble Traps	MHD 6
4	IS/ISO 18242 : 2016	Cardiovascular Implants and Extracorporeal Systems Centrifugal Blood Pumps	MHD 6
5	IS/ISO 8637 : Part 1 : 2017	Extracorporeal Systems for Blood Purification Part 1 Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators	MHD 6
6	IS/ISO 8637 : Part 2 : 2018	Extracorporeal Systems for Blood Purification Part 2 Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters	MHD 6
7	IS/ISO 8637 : Part 3 : 2018	Extracorporeal Systems for Blood Purification Part 3 Plasmafilters	MHD 6
8	IS/ISO 10993 : Part 4 : 2017	Biological evaluation of medical devices Part 4 Selection of tests for interactions with blood	MHD 19
9	IS/ISO 3826 : Part 1 : 2013	Plastics collapsible containers for human blood and blood components: Part 1 conventional containers	MHD 12
10	IS/IEC 60794 : Part 4 : Sec 20 : 2018	Optical Fibre Cables Part 4 Sectional specification Section 20 Aerial optical cables along electrical power lines Family specification for ADSS all dielectric self-supported optical cables	LITD 11
11	IS 15354 : Part 1 : 2018	Single - Use medical examination gloves: Part 1 specification for gloves made from rubber latex or rubber solution (First Revision)	MHD 12
12	IS/IEC 62044 : Part 1 : 2002	Cores made of soft magnetic materials Measuring methods Part 1: Generic specification	LITD 24
13	IS 7376 : 2023	Culinary Measures for Household Purposes Specification Second Revision of IS 7376	MED 33
14	IS/ISO 12097 : Part 1 : 2002	Road vehicles Airbag components Part 1: Vocabulary	TED 29
15	IS 16183 : Part 1 : 2023	Small craft - Hull construction and scantlings Part 1 Materials: Thermosetting resins, glass-fibre reinforcement, reference laminate	TED 18

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Clinical, pathological, anaesthetic and respiratory equipments and systems
Sub Sub Group	:	Biological tests
Aspect	:	Methods of tests
Certification	:	None
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)	:	10993-4:2017
Harmonized with	:	Others

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

List of Licenses under IS : IS/ISO 10993 : Part 4 : 2017

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 : 1

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 10993 : Part 4 : 2017

List of Expired or Cancelled Licenses under IS : IS/ISO 10993 : Part 4 : 2017

List of laboratories for : IS/ISO 10993 : Part 4 : 2017

List of Amendement(s) for : IS/ISO 10993 : Part 4 : 2017

List of Gazette Document(s) for : IS/ISO 10993 : Part 4 : 2017

List of Corigenda Document(s) for : IS/ISO 10993 : Part 4 : 2017

List of Product Manuals & SIT