IS 17932 : Part 5 : 2024 Biological Evaluation of Medical Devices - Part 5 Ethylene Oxide Sterilization Residuals (ISO 10993-7 : 2008, MOD)
(Superseding IS/ISO 10993-7 : 2018)
NATIONAL FOREWORD
This Indian Standard (Part 5) which is a modified adoption of ISO 10993-7 : 2008 'Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals' with Cor 1 : 2009 and Amd 1 : 2019 issued by the International Organization for Standardization (ISO) was adopted by Bureau of Indian Standards on the recommendation of the In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.
This standard was first published as IS/ISO 10993-7 : 2018 'Biological evaluation of medical devices: Part 7 Ethylene oxide sterilization residuals'. This supersession has been undertaken to incorporate the latest amendment.
The text of ISO standard may be approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following:
a) Wherever the words 'International Standard' appear referring to this standard, they should be read as 'Indian Standard'; and
b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker.