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YY/T 1544-2017 English PDF

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YY/T 1544-2017: Ethylene oxide sterilization safety and effectiveness basic supply requirements
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Basic data

Standard ID YY/T 1544-2017 (YY/T1544-2017)
Description (Translated English) Ethylene oxide sterilization safety and effectiveness basic supply requirements
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C47
Classification of International Standard 11.080.01
Word Count Estimation 12,196
Date of Issue 2017-05-02
Date of Implementation 2018-04-01
Regulation (derived from) China Food & Drug Administration Announcement 2017 No. 49
Issuing agency(ies) State Food and Drug Administration

YY/T 1544-2017: Ethylene oxide sterilization safety and effectiveness basic supply requirements

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Ethylene oxide sterilization safety and effectiveness basic supply requirements ICS 11.080.01 C47 People's Republic of China pharmaceutical industry standards Ethylene oxide sterilization Safety and effectiveness of the basic security requirements 2017-05-02 released 2018-04-01 implementation State Food and Drug Administration released Directory Foreword Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Quality Management System 1 5 Management responsibilities 2 6 staff requirements 2 Infrastructure 4 8 working environment 5 9 ethylene oxide sterilization system design 5 10 Environmental Monitoring 7 Appendix A (informative) Physical examination 9

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of this document may be patentable. The issuing agencies of this document do not have the responsibility to identify these patents. This standard proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee disinfection and equipment (SAC/TC200) centralized. The main drafting units of this standard. Shandong Xinhua Medical Devices Co., Ltd., Nanjing minimally invasive medical technology Co., Ltd., the national food and drug Quality Supervision, Inspection and Guangzhou Medical Devices Quality Supervision and Inspection Center, Shandong Weigao Group Medical Polymer Co., Ltd. The main drafters of this standard. Li Shuyong, Xu Honglei, Wang Hongmin, Ding Yanqin, Huang Hongxin, Xu Xingang, Yue Fang name. Ethylene oxide sterilization Safety and effectiveness of the basic security requirements

1 Scope

This standard specifies the Ethylene Oxide sterilization system quality management system, management responsibilities, personnel requirements, infrastructure, work environment, epoxy Ethane sterilization system design, environmental monitoring and other requirements. This standard applies to ethylene oxide sterilization, ethylene oxide sterilization provides a safe and effective basis for protection. This standard does not apply to regulate ethylene oxide sterilizer performance, use and ethylene oxide sterilization process requirements.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this article Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 19001 quality management system requirements (GB/T 19001-2008, ISO 9001.2008, IDT) GB 30000.3 Chemical Classification and Labeling - Part 3. Flammable gases GB 30000.18 Chemical Classification and Labeling Section 18. Acute toxicity GB 50016 architectural design code for fire protection GB 50057 lightning protection design specifications GB 50058 explosion hazardous environment power plant design specifications GB 50116 Automatic Fire Alarm System Design Specification GB 50257 electrical installation explosion and fire hazard electrical installations construction and acceptance criteria YY 0503 ethylene oxide sterilizer YY/T 0822 Sterilization with ethylene oxide liquefied gas

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Ethylene oxide sterilization system ethyleneoxidesterilizationsystem Use of ethylene oxide as a sterilization medium sterilization equipment, facilities, software, including supply, venues and other supporting environment General 3.2 Control area controlarea In ethylene oxide sterilization systems, there is a limit to the concentration of ethylene oxide.

4 quality management system

4.1 General requirements This standard is based on the relevant requirements of GB/T 19001, as well as the relevant laws and regulations, the establishment of ethylene oxide sterilization system quality control

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