YY/T 1544-2017 (YY/T1544-2017, YYT 1544-2017, YYT1544-2017)
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| YY/T 1544-2017 | English | 239 |
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Ethylene oxide sterilization safety and effectiveness basic supply requirements
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YY/T 1544-2017
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| 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 | 12,118 | | Date of Issue | 2017-05-02 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Shandong Xinhua Medical Devices Co., Ltd., Nanjing minimally invasive medical technology Co., Ltd., the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Shandong Weigao Group Medical Polymer Co., Ltd. | | Administrative Organization | National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC 200) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 49 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1544-2017
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 range 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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