| SNo |
IS Number |
Title |
Technical Committee |
|
1 |
IS 11137 : PART 2 : 2012 |
Analysis techniques for system reliABility: Part 2 procedure for failure mode and effects analysis (Fmea) (First Revision) |
LITD 2 |
|
2 |
IS 14944 : 2020 |
Surgical Dressings - Methods of Test ( first revision ) |
TXD 36 |
|
3 |
IS 4905 : 2015 |
Random sampling and randomization procedures (First Revision) |
MSD 3 |
|
4 |
IS 16546 : 2016 |
Clothing for protection against contact with blood and body fluids - Determination of the resistance of protective clothing materials to penetration by blood and body fluids - Test method using synthetic blood |
TXD 36 |
|
5 |
IS/ISO 10993 : Part 5 : 2009 |
Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity |
MHD 19 |
|
6 |
IS/ISO 10993 : Part 10 : 2010 |
Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization |
MHD 19 |
|
7 |
IS/ISO 11607 : Part 2 : 2006 |
Packaging for terminally sterilized medical devices: Part 2 validation requirements for forming, sealing and assembly processes |
MHD 12 |
|
8 |
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 |
|
9 |
IS/ISO 10993 : Part 7 : 2018 |
Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals |
MHD 19 |
|
10 |
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 |
|
11 |
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 |
