IS 18881 : Part 6 : 2024/ISO 13408-6 : 2021 Aseptic Processing of Health Care Products - Part 6 Isolator Systems

ICS 11.080.01

MHD 12

NATIONAL FOREWORD

This Indian Standard (Part 6) which is identical to ISO 13408-6 : 2021 'Aseptic processing of health care products - Part 6: Isolator systems' 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 after approval of the Medical Equipment and Hospital Planning Division Council.

This Indian Standard is published in seven parts. The other parts in this series are:

Part 1 General requirements

Part 2 Sterilizing filtration

Part 3 Lyophilization

Part 4 Clean-in-place technologies

Part 5 Sterilization in place

Part 7 Alternative processes for medical devices and combination products

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'; 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.