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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 19070 : 2025

IS Title/आईएस शीर्षक : Implants for Surgery ï¿½ Two-Part Addition-Cure Silicone Elastomers

Superseding IS/सुपरसीडिंग आईएस : None

Degree of Equivalence/समतुल्यता स्तर : Modified/Technically Equivalent

Number of Revisions/पुनरीक्षणों की संख्या : New Standard

Number of Amendments/संशोधनों की संख्या : No amendment issued

Aspect/पक्ष : Product Specification

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 02 (Orthopedic Instruments, Implants and Accessories 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 19070 : 2025
:

1	IS 5914 (Part 8) : 2023 ISO 3376: 2020	Methods of test for vulcanized rubbers: Part 12 Tear strength-crescent test piece First Revision	PCD 29
2	IS/IEC 60512-2-6 : 2002 IEC 60512-2-6: 2002	METHODS OF TEST FOR RUBBER, VULCANIZED OR THERMOPLASTIC PART 2 DETERMINATION OF HARDNESS SECTION 2 HARDNESS BETWEEN 10 IRHD AND 100 IRHD ( Fifth Revision )	PCD 29
3	IS 13360 (Part 5/Sec 2) : 2017 ISO 527-2 : 2012 Reviewed In : 2022	Plastics - Methods of testing: Part 5 mechanical properties section 2 determination of tensile properties - Test conditions for moulding and extrusion plastics (First Revision)	PCD 27
4	IS 11720 (Part 2) : 2013 ISO 3417 :2008 Reviewed In : 2019	Methods of test for synthetic rubber: Part 2 measurement of vulcanization characteristics with the oscillating disc curemeter (Second Revision)	PCD 29
5	IS 16848 : 2018 ISO 6502 : 2016	Rubber - Guide to the use of curemeters	PCD 29
6	IS 18852 (Part 1) : 2024 ISO 7755-1:2013	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD)	MHD 19
7	IS/ISO 10993-5 : 2009 ISO 10993-5 : 2009	Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity	MHD 19

International Standards Referred In IS 19070 : 2025

Standard contains no Cross Referenced International Standard.

IS 19070 : 2025
is Referred in following Indian Standards :

Standard contains no Cross Referenced Indian Standard.

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Implants
Sub Sub Group	:	Orthopaedic Implants
Aspect	:	Product Specification
Certification	:	Voluntary Certification
Relevant Ministries	:	Ministry of Health and Family Welfare - Department of Health and Family Welfare
Sustainable development Goals :
Short Commom Man's Title	:	Implants-Two-part addition-cure silicone elastomers
ITC-HS Code	:	N/A
Degree of Equivalence	:	Modified/Technically Equivalent
Identical/Equivalent International Standard(s)	:	ISO 14949:2001
Harmonized with	:	ISO

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

List of Licenses under IS : IS 19070 : 2025

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 19070 : 2025

List of Expired or Cancelled Licenses under IS : IS 19070 : 2025

List of laboratories for : IS 19070 : 2025

List of Amendement(s) for : IS 19070 : 2025

List of Gazette Document(s) for : IS 19070 : 2025

List of Corigenda Document(s) for : IS 19070 : 2025

List of Product Manuals & SIT