| 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/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 |
|
5 |
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 |
|
6 |
IS/ISO 80369 : Part 1 : 2018 |
Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 1 General Requirements |
MHD 14 |
|
7 |
IS 9000 : Part 7 : Sec 1 : 2018 |
Basic environmental testing procedures for electronic and electrical items: Part 7 impact test: Sec 1 shock (Test Ea) (Second Revision) |
LITD 1 |
|
8 |
IS 9000 : Part 7 : Sec 3 : 2019 |
Environmental testing: Part 7 tests :: Sec 3 test Ec: rough handling shocks, primarily for equipment - Types specimens (First Revision) |
LITD 1 |
|
9 |
IS/IEC 60529 : 2001 |
Degrees of protection provided by enclosures (IP Code) |
ETD 1 |
|
10 |
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 |
|
11 |
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 |
|
12 |
IS 13450 : Part 2 : Sec 2 : 2019 |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 2 high frequency surgical equipment and high frequency surgical accessories |
MHD 15 |
|
13 |
IS 15575 : Part 1 : 2016 |
Electroacoustics - Sound level meters: Part 1 specifications (First Revision) |
LITD 7 |
|
14 |
IS/ISO 62304 : 2015 |
Medical device software - Software life cycle processes |
MHD 14 |
|
15 |
IS/IEC 62366 : Part 1 : 2015 |
Medical Devices Part 1 Application of Usability Engineering to Medical Devices |
MHD 14 |
