IS 18319 : 2024/ISO 17665 : 2024 Sterilization of Health Care Products - Moist Heat - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
NATIONAL FOREWORD
This Indian Standard (First Revision) which is identical to ISO 17665 : 2024 'Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices' issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Equipment and Surgical Disposable Products Sectional Committee and after approval of the Medical Equipment and Hospital Planning Division Council.
This standard was first published in 2023 and was identical to ISO 17665-1 : 2006 'Sterilization of health care products - Moist heat - Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices'. This revision has been brought out to align it with the latest version of ISO 17665 : 2024.
The text of ISO standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions are, however, not identical to those used in 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.