| SNo |
IS Number |
Title |
Technical Committee |
|
1 |
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 |
|
2 |
IS/ISO 10993 : Part 3 : 2014 |
Biological evaluation of medical devices Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive toxicity (First Revision) |
MHD 19 |
|
3 |
IS/ISO 10993 : Part 5 : 2009 |
Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity |
MHD 19 |
|
4 |
IS/ISO 10993 : Part 6 : 2016 |
Biological evaluation of medical devices Part 6 Tests for local effects after implantation |
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 12 : 2021 |
Biological Evaluation of Medical Devices Part 12 Sample Preparation and Reference Materials |
MHD 19 |
|
7 |
IS/ISO 10993 : Part 17 : 2002 |
Biological Evaluation of Medical Devices Part 17 Establishment of Allowable Limits for Leachable Substances |
MHD 19 |
|
8 |
IS/ISO 11979 : Part 1 : 2018 |
Ophthalmic implants Intraocular lenses Part 1:Vocabulary First Revision |
MHD 5 |
|
9 |
IS/ISO 11979 : Part 2 : 1999 |
Ophthalmic implants - Intraocular lenses: Part 2 optical properties and test methods |
MHD 5 |
|
10 |
IS/ISO 11979 : Part 3 : 2006 |
Ophthalmic implants - Intraocular lenses: Part 3 mechanical properties and test methods |
MHD 5 |
|
11 |
IS/ISO 14971 : 2019 |
Medical devices - Application of risk management to medical devices First Revision |
MHD 14 |
|
12 |
IS/ISO 18369 :Part 4 : 2017 |
Ophthalmic optics Contact lenses Part 4: Physicochemical properties of contact lens materials First Revision |
MHD 5 |
|
13 |
IS/ISO 10993 : Part 2 : 2006 |
Biological Evaluation of Medical Devices Part 2 Animal Welfare Requirements (First Revision) |
MHD 19 |
