| SNo |
IS Number |
Title |
Technical Committee |
|
1 |
IS 13276 : Part 1 : 2000 |
Mechanical vibration and shock - Evaluation of human exposure to whole body vibration: Part 1 general requirements (First Revision) |
MED 28 |
|
2 |
IS/ISO 5349 : Part 1 : 2001 |
Mechanical vibration - Measurement and evaluation of human exposure to handtransmitted vibration: Part 1 general requirements (First Revision) |
MED 28 |
|
3 |
IS/ISO 5349 : PART 2 : 2001 |
Mechanical vibration - Measurement and evaluation of human exposure to handtransmitted vibration: Part 2 practical guidance for measurement at the workplace (First Revision) |
MED 28 |
|
4 |
IS/ISO 10993 : Part 1 : 2009 |
Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process |
MHD 19 |
|
5 |
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 |
|
6 |
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 |
|
7 |
IS/ISO 11137 : Part 2 : 2013 |
Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose |
MHD 12 |
|
8 |
IS/ISO 11607 : Part 1 : 2019 |
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials sterile barrier systems and packaging systems First Revision |
MHD 12 |
|
9 |
IS 16450 : 2017 |
Graphical symbols for use on equipment - Registered symbols |
PGD 1 |
|
10 |
IS 16819 : 2018 |
Safety of machinery - General principles for design - Risk assessment and risk reduction |
MED 40 |
|
11 |
IS 15727 : Part 1 : 2020 |
Textiles – Assessment of the ignitability of bedding items Part 1 Ignition source: Smouldering cigarette (first revision) |
TXD 32 |
|
12 |
IS 15727 : Part 2 : 2020 |
Textiles – Assessment of the ignitability of bedding items Part 2 Ignition source: Match-flame equivalent (first revision) |
TXD 32 |
|
13 |
IS/ISO 13485 : 2016 |
Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ) |
MHD 14 |
|
14 |
IS 16810 : Part 1 : 2018 |
Safety of machinery - Safety related parts of control systems: Part 1 general principles for design |
MED 40 |
|
15 |
IS 16810 : Part 2 : 2018 |
Safety of machinery - Safety related parts of control systems: Part 2 validation |
MED 40 |
|
16 |
IS 16818 : 2018 |
Safety of machinery - Emergency stop function - Principles for design |
MED 40 |
|
17 |
IS/ISO 14155 : 2011 |
Clinical investigation of medical devices for human subjects - Good clinical practice |
MHD 19 |
|
18 |
IS/ISO 14971 : 2019 |
Medical devices - Application of risk management to medical devices First Revision |
MHD 14 |
|
19 |
IS/ISO 15223 : Part 1 : 2016 |
Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( Second Revision ) |
MHD 14 |
|
20 |
IS/ISO 22442 : Part 1 : 2015 |
Medical Devices Utilizing Animal Tissues and their Derivatives Part 1 Application of Risk Management |
MHD 19 |
|
21 |
IS 16504 : Part 1 : 2019 |
Safety of Machinery — Electrical Equipment of Machines Part 1 General Requirements ( First Revision ) |
ETD 44 |
|
22 |
IS/IEC 60529 : 2001 |
Degrees of protection provided by enclosures (IP Code) |
ETD 1 |
|
23 |
IS 13450 : Part 1 : 2018 |
Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision) |
MHD 15 |
|
24 |
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 |
|
25 |
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 |
|
26 |
IS 13450 : Part 2 : Sec 52 : 2020 |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 52 Medical beds |
MHD 15 |
|
27 |
IS/IEC 60695 : Part 11 : Sec 10 : 2013 |
Fire hazard testing: Part 11 test flames :: Sec 10 50 w horizontal and vertical flame test methods |
LITD 1 |
|
28 |
IS/ISO 62304 : 2015 |
Medical device software - Software life cycle processes |
MHD 14 |
|
29 |
IS/IEC 62311 : 2019 |
Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields 0 Hz - 300 GHz |
LITD 9 |
|
30 |
IS/IEC 80601 : Part 2 : Sec 35 : 2009 |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 35 Heating devices using blankets, pads or mattresses and intended for heating in medical use |
MHD 15 |
|
31 |
IS/IEC 82304 : Part 1 : 2016 |
Health software: Part 1 general requirements for product safety |
MHD 17 |
|
32 |
IS 101 : Part 6 : Sec 1 : 1988 |
Methods of sampling and test for paints, varnishes and related products: Part 6 durability tests: Sec 1 resistance to humidity under conditions of condensation (Third Revision) |
CHD 20 |
