YY/T 1544-2017Ethylene oxide sterilization safety and effectiveness basic supply requirements (English PDF)
环氧乙烷灭菌安全性和有效性的基础保障要求
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 2, 2017
Implementation date
April 1, 2018
Scope
YY/T 1544-2017 is the English-translated version of 环氧乙烷灭菌安全性和有效性的基础保障要求.
YY/T 1544-2017 is the Chinese pharmaceutical industry standard that sets the safety requirements around an ethylene oxide sterilization system: the quality management system and the responsibilities of management, the qualification and training of personnel, the infrastructure and the working environment, the design of the sterilization system itself and the environmental monitoring around it, so that the process is run safely for the workers as well as effectively for the product. Issued on 2 May 2017, it has applied since 1 April 2018.
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Document preview — YY/T 1544-2017
National Standard of the People's Republic of China
- ICS
- 11.080.01
- Classification
- C 47
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Quality Management System
- 5 Management responsibilities
- 6 staff requirements
- 8 working environment
- 9 ethylene oxide sterilization system design
- 10 Environmental Monitoring
- Appendix A (informative) Physical examination
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
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 document. 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
Use of ethylene oxide as a sterilization medium sterilization equipment, facilities, software, including supply, venues and other supporting environment General
3.2 Control area
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 19001Quality management systems -- Requirements
- GB 30000.3Rules for classification and labelling of chemicals - Part 3: Flammable gases
- GB 30000.18Rules for classification and labelling of chemicals - Part 18: Acute toxicity
- GB 50016[2018 Edition of GB 50016-2014] Code for Fire Protection Design of Buildings [Code of Design on Building Fire Protection and Prevention]
- GB 50057Code for design protection of structures against lightning
- GB 50058Code for design of electrical installations in explosive atmospheres
Similar standards
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Related Standards
GB 30000.18-2013 — Rules for classification and labelling of chemicals - Part 18: Acute toxicity
GB 30000.3-2013 — Rules for classification and labelling of chemicals - Part 3: Flammable gases
GB 50016-2014 — Code for Fire Protection Design of Buildings (2018 Edition)
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YY/T 1544-2017
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