| 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 4 : 2017 |
Biological evaluation of medical devices Part 4 Selection of tests for interactions with blood |
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 11 : 2017 |
Biological evaluation of medical devices Part 11 Tests for systemic toxicity |
MHD 19 |
|
5 |
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 |
|
6 |
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 |
|
7 |
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 |
|
8 |
IS/ISO 11607 : Part 2 : 2019 |
Packing for Terminally Sterilized Medical Devices Part 2 Validation Requirements for Forming Sealing and Assembly Processes (First Revision) |
MHD 12 |
|
9 |
IS/ISO 14937 : 2009 |
Sterilization of health care products General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices |
MHD 12 |
|
10 |
IS 18319 : Part 1 : 2023 |
Sterilization of health care products Moist heat Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices |
MHD 12 |
|
11 |
IS/ISO 80369 : Part 7 : 2016 |
Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 7 Connectors for Intravascular or Hypodermic Applications |
MHD 12 |