YY/T 1612-2018Quality test method of steam in medical sterilization process (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard applies to the quality testing of steam used in medical device sterilization processes.

Example. Steam used in sterilization processes such as pressure steam sterilization and ethylene oxide sterilization.

This standard specifies the test methods for non-condensing gas content, dryness, superheat, steam condensate and other quality parameters of sterilization steam.

Note. The requirements of the above steam quality parameters can be found in the corresponding product standards. Some steam quality requirements are given in Appendix A.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 5750.5-2006 Standard Test Method for Drinking Water Standards Inorganic Non-Metal Indicators

GB/T 8538-2008 drinking natural mineral water test method

GB 8599-2008 Large steam sterilizer technical requirements Automatic control type Water quality -- Determination of iron and manganese -- Flame atomic absorption spectrophotometric method

GB/T 12149-2007 Determination of silicon in industrial circulating cooling water and boiler water

GB/T 14233.1-2008 Medical infusions, blood transfusions, injecting machines - Test methods - Part 1 GB/T.19971-2015 health care product sterilization terminology

3 Terms and definitions

The following terms and definitions as defined in GB/T.19971-2015 apply to this document.

4 Overview

4.1 Test environmental conditions should meet the following requirements.

a) Ambient temperature. 5 ° C ~ 40 ° C;

b) relative humidity. no more than 85%;