IS 18881 : Part 1 : 2025/ISO 13408-1 : 2023 Aseptic Processing of Health Care Products - Part 1 General Requirements

ICS 11.080.01

MHD 12

(Superseding IS/ISO 13408-1 : 2008)

NATIONAL FOREWORD

This Indian Standard (Part 1) which is identical to ISO 13408-1 : 2023 'Aseptic processing of health care products - Part 1: General requirements' 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 standard supersedes IS/ISO 13408-1 : 2008 'Aseptic processing of health care products: Part 1 General requirements'. After publication of this standard, IS/ISO 13408-1 : 2008 stands withdrawn. This Indian Standard is published in seven parts. The other parts in this series are:

Part 2 Sterilizing filtration

Part 3 Lyophilization

Part 4 Clean-in-place technologies

Part 5 Sterilization in place

Part 6 Isolator systems

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.