Documents(MHD)


S.No Document Number Document Title Doc Type Priority Language Document Stage Last Action Date
1 MHD/19/15611 In-vitro Diagnostic (IVD) Devices - Blood Gas Analyzers New 1 English PDF Sent To Technical Department 07-06-2024
2 MHD/19/15613 In-vitro Diagnostic (IVD) Devices - Electrolyte Analyzer New 3 English Pdf from Department 19-07-2024
3 MHD/19/21867
(Modified/Technically Equivalent To: ISO 10993-7:2019)
Biological Evaluation of Medical Devices Part 5 Ethylene oxide sterilization residuals New 3 English Pdf from Department 19-07-2024
4 MHD/19/22473
(Modified/Technically Equivalent To: ISO 10993-23:2021)
Biological Evaluation of Medical Devices Part 7 Tests for irritation ISO 10993-23:2021 MOD New 3 English Ready for Gazette 19-06-2024
5 MHD/19/25234 Blood Cell Counter Analyzer New 2 English Project-Approval 11-04-2024
6 MHD/19/25235 Hemoglobin Analyzer New 2 English Project-Approval 11-04-2024
7 MHD/19/25236
(Identical To: ISO/TS 37137-1:2021)
Biological evaluation of absorbable medical devices Part 1: General requirements New 2 English Project-Approval 11-04-2024
8 MHD/19/25237
(Identical To: ISO/TR 10993-33:2015)
Biological evaluation of medical devices Part 33: Guidance on tests to evaluate genotoxicity New 2 English Project-Approval 11-04-2024
9 MHD/19/25238
(Identical To: ISO/TR 10993-55:2023)
Biological evaluation of medical devices Part 55: Interlaboratory study on cytotoxicity New 2 English Project-Approval 11-04-2024