ICS 11.080.30                         MHD 12

Revised Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard (Part 1) (First Revision) which is identical with ISO 11607-1 : 2019 ‘Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems’ issued by the International Organization for Standardization was adopted by 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 standard was originally published in 2018 which was identical with ISO 11607-1 : 2006 ‘Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems’. The first revision of this standard has been undertaken to align it with the latest version of ISO 11607-1 : 2019.

This Indian Standard is published in two parts. The other part in this series is:

Part 2 Validation requirements for forming, sealing and assembly processes

The text of ISO standard may be 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 Standards, the current practice is to use a point (.) as the decimal marker.