YY/T 0883-2013Specification of process challenge devices and indicator systems for steam penetration testing (English PDF)
蒸汽渗透测试用过程挑战装置及指示物系统
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 21, 2013
Implementation date
October 1, 2014
Scope
YY/T 0883-2013 is the English-translated version of 蒸汽渗透测试用过程挑战装置及指示物系统.
YY/T 0883-2013 is the Chinese pharmaceutical industry standard that specifies the process challenge devices and the indicator systems used to test steam penetration in a sterilizer with a vacuum stage, that is a pre-vacuum sterilizer.
It sets the requirements and the test methods for them, the test itself resting on GB 8599-2008 and YY 0646-2008, and it covers the construction of the challenge device, the indicator and its reading, the reproducibility of the result and the marking. Issued on 21 October 2013, it has applied since 1 October 2014.
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Document preview — YY/T 0883-2013
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
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 requires
- Appendix A (normative) vapor exposure test equipment and steam
- Appendix B (normative) hollow load process challenge device and test cycle indicator system
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
The contents of this standard reference to EN 867-5:2001 "sterilizers non-biological indicator systems - Part 5. B-type and S-type small off
Bacteria performance indicator system testing and process challenges require device "(in English).
1 Scope
This standard specifies the steam sterilizer with vacuum stage (pre-vacuum) were steam penetration test process challenge devices and indicator System requirements, test methods. Steam penetration test of the standard referred to is based on GB 8599-2008 and the YY 0646-2008 Provisions.
This standard applies to the process challenge device and indicator system, comprising a porous load process challenge device and load indicator system and the cavity is too Cheng challenge means and indicator systems.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. Laboratory use specifications and test methods GB/T 6682-2008 Analysis
GB 8599-2008 large steam sterilizers technical requirements for automatic control type
GB 18282.3-2009 Sterilization of health care products - Chemical indicators - Part 3. Class steam penetration test for BD II Class 2 indicator systems
GB 18282.4-2009 Sterilization of health care products - Chemical indicators - Part 4. Class for alternative BD steam penetration test Test two types of indicators
GB/T 24628-2009 Sterilization of health care products biological and chemical indicators of test equipment
YY 0646-2008 small steam sterilizer automatic control type
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Indicator
Indicator to its final application substrate to form a combination.
3.2 Indicator
The combination of active substance or active substances.
3.3 Indicator system
Combination indicator and its substrate, followed by testing for a particular load combination.
Note: The relationship between the indicator, the indicator, the indicator system, see ISO 11140-1:2005 Appendix E.
3.4 Process challenge device
For the specific resistance of the sterilization process constitutes a means for evaluation of the effectiveness of the sterilization process.
Note: See GB 8599-2008 of 3.12 and 3.11 in YY 0646-2008.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 8599-2008Technical requirements for large steam sterilizers
- GB 18282.3-2009Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
- GB 18282.4-2009Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
- GB/T 24628-2009Sterilization of health care products - Biological and chemical indicators - Test equipment
- YY 0646-2008Small steam sterilizers - Automatic type
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Related Standards
GB 18282.3-2009 — Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
GB 18282.4-2009 — Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
GB 8599-2008 — Technical requirements for large steam sterilizers
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