| SNo |
IS Number |
Title |
Technical Committee |
|
1 |
IS/ISO 10993 : Part 1 : 2009 |
Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process |
MHD 19 |
|
2 |
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 |
|
3 |
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 |
|
4 |
IS/ISO 11137 : Part 2 : 2013 |
Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose |
MHD 12 |
|
5 |
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 |
|
6 |
IS/ISO 11607 : Part 1 : 2006 |
Packaging for terminally sterilized medical devices: Part 1 requirements for materials, sterile barrier systems and packaging systems |
MHD 12 |
|
7 |
IS/ISO 13485 : 2016 |
Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ) |
MHD 14 |
|
8 |
IS/ISO 14155 : 2011 |
Clinical investigation of medical devices for human subjects - Good clinical practice |
MHD 19 |
|
9 |
IS/ISO 14971 : 2019 |
Medical devices - Application of risk management to medical devices First Revision |
MHD 14 |
|
10 |
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 |
|
11 |
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 |
|
12 |
IS/ISO/IEC 17025 : 2017 |
General requirements for the competence of testing and calibration laboratories (Second Revision) |
MSD 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/TR 22442 : Part 4 : 2010 |
Medical Devices Utilizing Animal Tissues and their Derivatives Part 4 Principles for Elimination and/or Inactivation of Transmissble Spongifrom Encephalopathy (TSE) Agents and Validation Assays for those Processes |
MHD 19 |
|
16 |
IS/IEC 62366 : Part 1 : 2015 |
Medical Devices Part 1 Application of Usability Engineering to Medical Devices |
MHD 14 |
