IS 18319 : Part 1 : 2023/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

ICS 11.080.01

MHD 12

NATIONAL FOREWORD

This Indian Standard (Part 1) which is identical with 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' issued by the International Organization for Standardization (ISO) was adopted by Bureau of Indian Standards on the recommendation of the Hospital Equipment and Surgical Disposable Products Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

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.