| 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 2 : 2006 |
Biological Evaluation of Medical Devices Part 2 Animal Welfare Requirements (First Revision) |
MHD 19 |
|
3 |
IS/ISO 10993 : Part 6 : 2016 |
Biological evaluation of medical devices Part 6 Tests for local effects after implantation |
MHD 19 |
|
4 |
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 |
|
5 |
IS/ISO 13408 : Part 1 : 2008 |
Aseptic processing of health care products Part 1 General requirements |
MHD 12 |
|
6 |
IS/ISO 14155 : 2011 |
Clinical investigation of medical devices for human subjects - Good clinical practice |
MHD 19 |
|
7 |
IS/ISO 14971 : 2019 |
Medical devices - Application of risk management to medical devices First Revision |
MHD 14 |
|
8 |
IS/ISO 15223 : Part 1 : 2016 |
Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( Second Revision ) |
MHD 14 |
|
9 |
IS/ISO 8980 : Part 3 : 2013 |
Ophthalmic optics - Uncut finished spectacle lenses: Part 3 transmittance specifications and test methods |
MHD 5 |
