SNo |
IS Number |
Title |
Technical Committee |
1 |
IS 9001 : Part 1 : 1984 |
Guidance for environmental testing: Part 1 General |
LITD 1 |
2 |
IS/ISO 10993 : Part 1 : 2009 |
Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process |
MHD 19 |
3 |
IS 13450 : Part 1 : Sec 6 : 2020 |
Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 6 Collateral standard: Usability |
MHD 15 |
4 |
IS 13450 : Part 1 : Sec 10 : 2019 |
Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 10 Collateral standard: Requirements for the development of physiologic closed-loop controllers |
MHD 15 |
5 |
IS 13450 : Part 1 : Sec 11 : 2020 |
Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 11 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
MHD 15 |
6 |
IS/ISO 14708 : Part 1 : 2014 |
Implants for surgery - Active implantable medical devices: Part 1 general requirements for safety, marking and for information to be provided by the manufacturer (First Revision) |
MHD 7 |
7 |
IS/ISO 14971 : 2019 |
Medical devices - Application of risk management to medical devices First Revision |
MHD 14 |
8 |
IS/IEC 62366 : Part 1 : 2015 |
Medical Devices Part 1 Application of Usability Engineering to Medical Devices |
MHD 14 |