IS/ISO 11140-5 : 2007 Sterilization of Health Care Products - Chemical Indicators Part 5 Class 2 Indicators for Bowie and Dick-Type Air Removal Tests

ICS 11.080.01

MHD 12

Revised Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard (Part 5) which is identical with ISO 11140-5 : 2007 ‘Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests’ 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 air removal test is used to evaluate the efficacy of air removal during the pre-vacuum phase of a pre-vacuum sterilization cycle or during the pulsing stage of positive pulsing cycles if non-condensable gases were present in the steam. Retention of air due to an inefficient air removal stage or the presence of an air leak or non-condensable gases during the air removal stage are circumstances which can lead to failure of the test. This standard describes the requirements for Class 2 indicators for Bowie and Dick-type air removal test sheets and packs.

This standard is one of the series of Indian Standards on ‘Sterilization of health care products - Chemical indicators’. Other parts published so far in this series are:

Part 1 General requirements

Part 3 Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

Part 4 Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

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.