| SNo |
IS Number |
Title |
Technical Committee |
|
1 |
IS/ISO 10555 : PART 1 : 2013 |
Intravascular catheters - Sterile and single - Use catheters: Part 1 general requirements (First Revision) |
MHD 12 |
|
2 |
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 |
|
3 |
IS/ISO 10993 : Part 2 : 2006 |
Biological Evaluation of Medical Devices Part 2 Animal Welfare Requirements (First Revision) |
MHD 19 |
|
4 |
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 |
|
5 |
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 |
|
6 |
IS/ISO 11137 : Part 2 : 2013 |
Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose |
MHD 12 |
|
7 |
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 |
|
8 |
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 |
|
9 |
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 |
|
10 |
IS/ISO 14155 : 2020 |
Clinical investigation of medical devices for human subjects - Good clinical practice |
MHD 19 |
|
11 |
IS 18076 : 2023 |
Non-active surgical implants - General requirements |
MHD 2 |
|
12 |
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 |
|
13 |
IS/ISO 14971 : 2019 |
Medical devices - Application of risk management to medical devices First Revision |
MHD 14 |
|
14 |
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 |
|
15 |
IS/ISO 15223 : Part 2 : 2010 |
Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied: Part 2 symbol development, selection and validation |
MHD 14 |
|
16 |
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 |
|
17 |
IS/ISO 22442 : Part 1 : 2015 |
Medical Devices Utilizing Animal Tissues and their Derivatives Part 1 Application of Risk Management |
MHD 19 |
|
18 |
IS 17922 : Part 1 : 2023 |
Medical Devices Part 1: Application of Usability Engineering |
MHD 14 |
|
19 |
IS 18529 : 2024 |
Sterile single-use intravascular introducers, dilators and guidewire |
MHD 12 |
|
20 |
IS 18742 : Part 1 : 2024 |
Processing of health care products � Information to be provided by the medical device manufacturer for the processing of medical devices Part 1 Critical and semi-critical medical devices |
MHD 12 |
|
21 |
IS/ISO 20417 : 2021 |
Medical devices Information to be supplied by the manufacturer |
MHD 14 |
|
22 |
IS/ISO 13485 : 2016 |
Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ) |
MHD 14 |
