MHD 14  New Standards List


Total Standards :  6

S.No IS Number IS Title Aspect Degree of Equivalence
(E)
Date of Pub.
(F)
Document Action
1 IS 18325 : 2023
ISO/TS 20914:2019
Medical laboratories Practical guidance for the estimation of measurement uncertainty Code of Practice Identical under dual numbering 01-09-2023
2 IS 17922 (Part 1) : 2023
IEC 62366-1: 2015 CSV
Medical Devices Part 1: Application of Usability Engineering Process Specification Identical under dual numbering 11-12-2023
3 IS 18374 : 2023
ISO 23162:2021
Basic semen examination Specification and test methods Process Specification Identical under dual numbering 11-12-2023
4 IS 18376 : 2023
ISO/TR 20416: 2020
Medical devices Post-market surveillance for manufacturers Code of Practice Identical under dual numbering 11-12-2023
5 IS/ISO 20417 : 2021
ISO 20417:2021
Medical devices Information to be supplied by the manufacturer Code of Practice Identical under single numbering 26-06-2024
6 IS/IEC/TR 80002-3 : 2014
IEC/TR 80002-3: 2014
Medical device software Part 3: Process reference model of medical device software life cycle processes IEC 62304 Code of Practice Identical under single numbering 19-07-2024