Revised Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard (Part 1) which is identical with ISO 11137-1 : 2006 ‘Sterilization of healthcare products —Radiation — Part 1: Requirements for 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 approval of the Medical Equipment and Hospital Planning Division Council.

Amendment No. 1 published in 2013 to the above International Standard has been given at the end of this publication.

This standard is published in three parts. Other parts of this standard are:

Part 2 Establishing the sterilization dose

Part 3 Guidance on dosimetric aspects

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’.

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.