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YY/T 1612-2018 English PDF

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YY/T 1612-2018: Quality test method of steam in medical sterilization process
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Basic data

Standard ID YY/T 1612-2018 (YY/T1612-2018)
Description (Translated English) Quality test method of steam in medical sterilization process
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C47
Classification of International Standard 11.080.10
Word Count Estimation 14,177
Date of Issue 2018-09-29
Date of Implementation 2019-10-01
Quoted Standard GB/T 5750.5-2006; GB/T 8538-2008; GB 8599-2008; GB/T 11911-1989; GB/T 12149-2007; GB/T 14233.1-2008; GB/T 19971-2015
Regulation (derived from) State Drug Administration Announcement No. 72 of 2018
Issuing agency(ies) State Drug Administration
Summary This standard applies to the quality testing of steam used in medical device sterilization processes. This standard specifies the test methods for non-condensing gas content, dryness, superheat, steam condensate and other quality parameters of sterilization steam.

YY/T 1612-2018: Quality test method of steam in medical sterilization process

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Quality test method of steam in medical sterilization process ICS 11.080.10 C47 People's Republic of China Pharmaceutical Industry Standard Test method for medical sterilization steam quality Published on.2018-09-28 2019-10-01 implementation State Drug Administration issued

Content

Foreword I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Overview 1 5 Non-condensing gas content test 2 6 dryness test 3 7 superheat test 6 8 Steam Condensate Test 7 Appendix A (informative) Steam quality requirements 9 Appendix B (informative appendix) Vaporization heat comparison table 10

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200). This standard was drafted. Shandong Xinhua Medical Devices Co., Ltd., Guangdong Medical Device Quality Supervision and Inspection Institute, Beijing Maidi Jin Cheng Medical Supplies Co., Ltd. The main drafters of this standard. Xu Rongkai, Hu Changming, Han Cong, Lu Liansheng, Han Jiankang. Test method for medical sterilization steam quality

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 article. Pieces. 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. 3.1 Saturated steam sataturatedteam Evaporation and liquefaction are in dynamic equilibrium when the number of molecules entering the vapor space per unit time is equal to the number of molecules in the return liquid. steam. 3.2 Superheated steam superheatedsteam Water vapor at a temperature above the boiling point of water at the corresponding pressure. 3.3 Non-condensable gas Air and other gases that do not condense under steam sterilization conditions.

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%;

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