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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS/ISO 10993-5 : 2009
ISO 10993-5 : 2009

IS Title/आईएस शीर्षक : Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity

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 : 0

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 10993-5 : 2009
ISO 10993-5 : 2009
:

Details could not be found.

International Standards Referred In IS/ISO 10993-5 : 2009
ISO 10993-5 : 2009

Standard contains no Cross Referenced International Standard.

IS/ISO 10993-5 : 2009
ISO 10993-5 : 2009
is Referred in following Indian Standards :

1	IS/ISO 4074 : 2015	Natural rubber latex male condoms - Requirements and test methods (First Revision)	MHD 3
2	IS/ISO 7405 : 2008	Dentistry - Evaluation of biocompatibility of medical devices used in dentistry	MHD 19
3	IS/ISO 7198 : 2016	Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches	MHD 6
4	IS 17334 : 2019	Medical textiles – Surgical gowns and surgical drapes – Specification	TXD 36
5	IS 17348 : 2020	Medical textiles – Adhesive incise drape – Specification	TXD 36
6	IS 17350 : 2020	Medical textiles – Abdominal binder – Specification	TXD 36
7	IS 17351 : 2020	Medical textiles – Dressing, shell compressed – Specification	TXD 36
8	IS 17352 : 2020	Medical textiles – Foam dressing – Specification	TXD 36
9	IS 17410 : 2020	Medical Textiles â€” Bio-Protective Coverall â€” Specification	TXD 36
10	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
11	IS 17506 : 2020	Medical Textiles - Hydrocolloid Dressing - Specification	TXD 36
12	IS 17507 : 2020	Medical Textiles - Cellulose Wading - Specification	TXD 36
13	IS 17508 : 2020	Disposable Adult Incontinence Diaper - Specification	TXD 36
14	IS 11552 : 2008	Liquid Nitrogen Vessels of Capacity up to 75 Litres	MED 17
15	IS 14740 : Part 3 : 2021	Pneumatic Fluid Power - Determination of Flow-Rate Characteristics of Components Using Compressible Fluids Part 3 Method for Calculating Steady-State Flow-Rate Characteristics of Systems ( First Revision )	PGD 36
16	IS/ISO 11607 : Part 1 : 2019	Packaging for terminally sterilized medical devices - Part 1: Requirements for materials sterile barrier systems and packaging systems First Revision	MHD 12
17	IS 17423 : 2020	Medical textiles – Coveralls for COVID 19 – Specification	TXD 36
18	IS/ISO 3826 : Part 1 : 2013	Plastics collapsible containers for human blood and blood components: Part 1 conventional containers	MHD 12
19	IS 13009 : 2000	Contraceptive devices - Tubal ring - Specification (First Revision)	MHD 3
20	IS/ISO 16929 : 2019	Plastics - Determination of the degree of disintegration of plastic materials under defined composting conditions in a pilot-scale test First Revision	PCD 27
21	IS 16660 : 2017	Medical textiles - Nonwoven bandage rolls - Specification	TXD 36
22	IS 229 : 2021	Ethyl acetate - Specification (Fourth Revision)	PCD 9
23	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
24	IS 4972 : Part 7 : 2022	Resistance Spot Welding Part 7 Electrode Taper Fits For Spot Welding Equipment -- Dimensions (First Revision of IS 4972)	MTD 11
25	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
26	IS 17929 : Part 3 : 2022	Fibre ropes for offshore station keeping part 3: High modulus polyethylene HMPE	TXD 9
27	IS 13360 : Part 11 : Sec 15 : 2022	PLASTICS - METHODS OF TESTING PART 11 SPECIAL PROPERTIES Section 15 Determination of Viscosity using a Falling-Ball Viscometer Inclined-tube method	PCD 27
28	IS 5457 : 2022	SIZES OF FOLDERS AND FILES SPECIFICATION	CHD 15

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	:
Degree of Equivalence	:	Identical under single numbering
Identical/Equivalent International Standard(s)	:	ISO 10993-5 : 2009
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 5 : 2009

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 : 0

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 5 : 2009

List of Expired or Cancelled Licenses under IS : IS/ISO 10993 : Part 5 : 2009

List of laboratories for : IS/ISO 10993 : Part 5 : 2009

List of Amendement(s) for : IS/ISO 10993 : Part 5 : 2009

List of Gazette Document(s) for : IS/ISO 10993 : Part 5 : 2009

List of Corigenda Document(s) for : IS/ISO 10993 : Part 5 : 2009

List of Product Manuals & SIT