Revised Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard which is identical with ISO 11135 : 2014 ‘Sterilization of health-care products — Ethylene oxide — 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 approval of the Medical Equipment and Hospital Planning Division Council.

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.