SNo |
IS Number |
Title |
Technical Committee |
1 |
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 |
2 |
IS/ISO 13485 : 2016 |
Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ) |
MHD 14 |
3 |
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 |
4 |
IS/ISO 14971 : 2019 |
Medical devices - Application of risk management to medical devices First Revision |
MHD 14 |