| SNo |
IS Number |
Title |
Technical Committee |
|
1 |
IS/ISO 4871 : 1996 |
Acoustics - Declaration and Verification of Noise Emission Values of Machinery and Equipment |
MED 7 |
|
2 |
IS/ISO 5356 : Part 1 : 2015 |
Anaesthetic and respiratory equipment - Conical connectors: Part 1 cones and sockets (First Revision) |
MHD 11 |
|
3 |
IS/ISO 9000 : 2015 |
Quality management systems - Fundamentals and vocabulary (Fourth Revision) |
MSD 2 |
|
4 |
IS 13450 : Part 1 : 2018 |
Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision) |
MHD 15 |
|
5 |
IS 13450 : Part 1 : SEC 2 : 2018 |
Medical electrical equipment: Part 1 general requirements for the basic safety and essential performance: Sec 2 collateral standard: electromagnetic disturbances - Requirements and tests (First Revision) |
MHD 15 |
|
6 |
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 |
|
7 |
IS 13450 : Part 1 : Sec 8 : 2019 |
Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 8 Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
MHD 15 |
|
8 |
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 |
|
9 |
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 |
|
10 |
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 |
|
11 |
IS 15575 : Part 1 : 2016 |
Electroacoustics - Sound level meters: Part 1 specifications (First Revision) |
LITD 7 |
|
12 |
IS/ISO 16142 : Part 1 : 2016 |
Medical Devices - Recognized Essential Principles of Safety and Performance of Medical Devices Part 1 General Essential Principles and Additional Specific Essential Principles for all Non-IVD Medical Devices and Guidance on the Selection of Standards |
MHD 14 |
|
13 |
IS/ISO 62304 : 2015 |
Medical device software - Software life cycle processes |
MHD 14 |
|
14 |
IS/IEC 62366 : Part 1 : 2015 |
Medical Devices Part 1 Application of Usability Engineering to Medical Devices |
MHD 14 |
|
15 |
IS/ISO 80369 : Part 1 : 2018 |
Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 1 General Requirements |
MHD 14 |
