IS/ISO 11137 : Part 3 : 2017 Sterilization of Health Care Products - Radiation Part 3 Guidance on Dosimetric Aspects of Development, Validation and Routine Control
New Standard from Last Update.
NATIONAL FOREWORD
This Indian Standard (Part 3) which is identical with ISO 11137-3 : 2017 ‘Sterilization of healthcare products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on recommendation of the Hospital Equipment and Surgical Disposable Products Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.
This Indian Standard is published in three parts. The other parts in this series are:
Part 1 Requirements for development, validation and routine control of a sterilization process for medical devices
Part 2 Establishing the sterilization dose
The text of the ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain terminologies and 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’.
b) Comma (,) has been used as a decimal marker, while in Indian Standard, the current practice is to use a point (.) as the decimal marker.