IS 17932 : Part 1 : 2023 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing within a Risk Management Process (ISO 10993-1 : 2018, MOD)
(Superseding IS/ISO 10993-1 : 2009)
New Standard from Last Update.
NATIONAL FOREWORD
This Indian Standard (Part 1) which is a modified adoption of ISO 10993-1 : 2018 ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process’ issued by the International Organization for Standardization was adopted by Bureau of Indian Standards on the recommendation of Biological Evaluation of Medical Devices and In-vitro Diagnostic Medical Devices Sectional Committee MHD 19 and approval of the Medical Equipment and Hospital Planning Division Council.
This standard was first published in 1994 as IS 12572 (Part 1) : 1994 ‘Biological evaluation of medical devices: Part 1 Guidance on selection of tests (first revision)’ identical with ISO 10993-1 : 1992. This standard was superseded by IS/ISO 10993-1 : 2009 ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process’. This supersession has been undertaken to align it with the latest edition of ISO 10993-1 : 2018.