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Indian Standard Details

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Basic Details
IS Number : IS 19070:2025
IS Title [Eng-Hn] : Implants for Surgery - Two-Part Addition-Cure Silicone Elastomers
No of Revision : 0
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 2 ( Orthopedic Instruments, Implants and Accessories )
Language : English

Classification Details
Group : Medical and Hospital Equipments
Sub Group: Implants
Sub Sub Group : Orthopaedic Implants
Aspects: Product Specification
Certification:
Ministry : Ministry of Health and Family Welfare - Department of Health and Family Welfare
Short Commom Man's Title: Implants-Two-part addition-cure silicone elastomers
Itchs: N/A
Degree of Equivalence: Modified/Technically Equivalent
Identical/Equivalent Standards:ISO 14949:2001
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS 19070 : 2025 :
SNo IS Number Title Technical Committee
1
IS 3400 : Part 12 : 2022 Methods of test for vulcanized rubbers: Part 12 Tear strength-crescent test piece First Revision PCD 29
2
IS 3400 : Part 2 : Sec 2 : 2023 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 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 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 Rubber - Guide to the use of curemeters PCD 29
6
IS 17932 : Part 1 : 2023 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 : Part 5 : 2009 Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity MHD 19
International Standards Refered In IS 19070 : 2025
SNo International Standard Number
1 ISO 2418 : 0 : 0 0
2 ISO 2589 : 0 : 0 0
3 ISO 2419 : 0 : 0 0
IS 19070 : 2025 is Refered in following Indian Standards : Standard contains no Cross Referenced Indian Standard.