| 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 6 : 2016 |
Biological evaluation of medical devices Part 6 Tests for local effects after implantation |
MHD 19 |
|
3 |
IS/ISO 10993 : Part 7 : 2018 |
Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals |
MHD 19 |
|
4 |
IS/ISO 10993 : Part 9 : 2009 |
Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products |
MHD 19 |
|
5 |
IS/ISO 10993 : Part 16 : 2017 |
Biological Evaluation of Medical Devices Part 16 Toxicokinetic Study Design for Degradation Products and Leachables |
MHD 19 |
|
6 |
IS/ISO 11135 : 2014 |
Sterilization of health - Care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices |
MHD 12 |
|
7 |
IS/ISO 11137 : Part 1 : 2006 |
Sterilization of health care products - Radiation: Part 1 requirements for development, validation and routine control of a sterilization process for medical devices |
MHD 12 |
|
8 |
IS/ISO 11137 : Part 2 : 2013 |
Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose |
MHD 12 |
|
9 |
IS/ISO 11137 : Part 3 : 2017 |
Sterilization of Health Care Products ― Radiation Part 3 Guidance on Dosimetric Aspects of Development, Validation and Routine Control |
MHD 12 |
|
10 |
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 |
|
11 |
IS/ISO 14155 : 2011 |
Clinical investigation of medical devices for human subjects - Good clinical practice |
MHD 19 |
|
12 |
IS/ISO 14971 : 2019 |
Medical devices - Application of risk management to medical devices First Revision |
MHD 14 |
|
13 |
IS/ISO 22442 : Part 1 : 2015 |
Medical Devices Utilizing Animal Tissues and their Derivatives Part 1 Application of Risk Management |
MHD 19 |
|
14 |
IS/ISO 22442 : Part 2 : 2015 |
Medical Devices Utilizing Animal Tissues and their Derivatives Part 2 Controls on Sourcing, Collection and Handling |
MHD 19 |
|
15 |
IS/ISO 13408 : Part 1 : 2008 |
Aseptic processing of health care products Part 1 General requirements |
MHD 12 |
|
16 |
IS/ISO 8980 : Part 3 : 2013 |
Ophthalmic optics - Uncut finished spectacle lenses: Part 3 transmittance specifications and test methods |
MHD 5 |
