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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS/ISO 10993-10 : 2010
ISO 10993-10 : 2010

IS Title/आईएस शीर्षक : Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization (Withdrawn)

Superseded by IS/प्रतिस्थापित आईएस : IS 17932 (Part 6) : 2023

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

Gazette Document : 1

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Classification details for: IS/ISO 10993 : Part 10 : 2010

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Cross Reference Details

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Cross Reference Details

Indian Standards Referred In IS IS/ISO 10993-10 : 2010
ISO 10993-10 : 2010
:

1	IS 10370 (Part 3) : 1982 Reviewed In : 2023	Dimensions of mounting accessories of pot cores for wired circuits: Part 3 for pot cores of size 18 x 14 mm	LITD 24
2	IS 11140 : 2024	Specification for footrest assembly for mopeds	TED 6
3	IS 11159 (Part 2) : 2021	Classification of lubricants industrial oils and related products: Part 2 family a (Total Loss Systems)	PCD 25
4	IS 11162 (Part 1) : 1985 Reviewed In : 2019	Dimensions of non - Insulated terminal tags for electronic equipment: Part 1 type 1	LITD 3
5	IS 1200 (Part 26) : 1987 Reviewed In : 2022 Reaffirmed but not taken up for revision	Method of measurement of building and civil engineering work: Part 26 acid resistant lining	CED 44
6	IS 12280 : 1988 Reviewed In : 2019 Reaffirmed but not taken up for revision	Specification for tenon without counterbore	PGD 35
7	IS 12281 : 1988 Reviewed In : 2019 Reaffirmed but not taken up for revision	Mounting dimensions of machine tool doors with hinges	PGD 35
8	IS 12284 : 1988 Reviewed In : 2020	Specification for prepreg for ruse in multilayer printed boards	LITD 5
9	IS 12285 : 2018 ISO/IEC 7480 : 1991 Reviewed In : 2023	Information technology - Telecommunications and information exchange between systems - Start - Stop transmission signal quality at DTE/DCE interfaces (First Revision)	LITD 13

International Standards Referred In IS/ISO 10993-10 : 2010
ISO 10993-10 : 2010

Standard contains no Cross Referenced International Standard.

IS/ISO 10993-10 : 2010
ISO 10993-10 : 2010
is Referred in following Indian Standards :

1	IS/ISO 10993 : Part 10 : 2010	Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization	MHD 19
2	IS/ISO 10993 : Part 10 : 2010	Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization	MHD 19
3	IS/ISO 10993 : Part 10 : 2010	Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization	MHD 19
4	IS/ISO 10993 : Part 10 : 2010	Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization	MHD 19
5	IS/ISO 10993 : Part 10 : 2010	Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization	MHD 19
6	IS/ISO 10993 : Part 10 : 2010	Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization	MHD 19
7	IS/ISO 10993 : Part 10 : 2010	Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization	MHD 19
8	IS/ISO 10993 : Part 10 : 2010	Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization	MHD 19
9	IS/ISO 10993 : Part 10 : 2010	Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization	MHD 19
10	IS/ISO 7198 : 2016	Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches	MHD 6
11	IS 17334 : 2019	Medical textiles – Surgical gowns and surgical drapes – Specification	TXD 36
12	IS 17348 : 2020	Medical textiles – Adhesive incise drape – Specification	TXD 36
13	IS 17350 : 2020	Medical textiles – Abdominal binder – Specification	TXD 36
14	IS 17351 : 2020	Medical textiles – Dressing, shell compressed – Specification	TXD 36
15	IS 17352 : 2020	Medical textiles – Foam dressing – Specification	TXD 36
16	IS 17410 : 2020	Medical Textiles â€” Bio-Protective Coverall â€” Specification	TXD 36
17	IS 17506 : 2020	Medical Textiles - Hydrocolloid Dressing - Specification	TXD 36
18	IS 17507 : 2020	Medical Textiles - Cellulose Wading - Specification	TXD 36
19	IS 17508 : 2020	Disposable Adult Incontinence Diaper - Specification	TXD 36
20	IS 11552 : 2008	Liquid Nitrogen Vessels of Capacity up to 75 Litres	MED 17
21	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
22	IS/ISO 11607 : Part 1 : 2019	Packaging for terminally sterilized medical devices â€” Part 1: Requirements for materials sterile barrier systems and packaging systems First Revision	MHD 12
23	IS 17423 : 2020	Medical textiles – Coveralls for COVID 19 – Specification	TXD 36
24	IS/ISO 3826 : Part 1 : 2013	Plastics collapsible containers for human blood and blood components: Part 1 conventional containers	MHD 12
25	IS 13009 : 2000	Contraceptive devices - Tubal ring - Specification (First Revision)	MHD 3
26	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
27	IS 229 : 2021	Ethyl acetate - Specification (Fourth Revision)	PCD 9
28	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
29	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
30	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
31	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

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	:	11.100.20
Degree of Equivalence	:	Identical under single numbering
Identical/Equivalent International Standard(s)	:	ISO 10993-10:2010
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 10993 : Part 10 : 2010

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 : 1

Classification details for: IS/ISO 10993 : Part 10 : 2010

Cross Reference Details

Cross Reference Details

Classification Details

Email Ids

List of Licenses under IS : IS/ISO 10993 : Part 10 : 2010

List of Expired or Cancelled Licenses under IS : IS/ISO 10993 : Part 10 : 2010

List of laboratories for : IS/ISO 10993 : Part 10 : 2010

List of Amendement(s) for : IS/ISO 10993 : Part 10 : 2010

List of Gazette Document(s) for : IS/ISO 10993 : Part 10 : 2010

List of Corigenda Document(s) for : IS/ISO 10993 : Part 10 : 2010

List of Product Manuals & SIT