YY/T 0567.5-2011Aseptic processing of health care products - Part 5: Sterilization in place (English PDF)
医疗保健产品的无菌加工 第5部分：在线灭菌
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 31, 2011
Implementation date
June 1, 2013
Scope
YY/T 0567.5-2011 is the English-translated version of 医疗保健产品的无菌加工 第5部分：在线灭菌.
YY/T 0567.5-2011 is the Chinese standard "Aseptic processing of health care products - Part 5: Sterilization in place".
Its scope clause reads: YY/T 0567 provisions of this section by aseptic processing of health care products to the production of sterile equipment product contact surfaces Online sterilization (SIP) of the general requirements, and to provide authentication, validation, operation and control guidelines.
Note. SIP can be achieved through the use of steam or other gases or liquid sterilant. Appendix A gives the most common method --- Special steam sterilization online guide.
This section applies to the sterilizing agent is fed to the interior surface of the device so that the process of contact with the product. This section does not apply to the device is disassembled to the sterilization process.
This section does not replace or substitute for national regulatory requirements, particularly those belonging to the requirements of the jurisdiction within the country or region, such as production management practices (GMPs) and/or the pharmacopoeia requirements.
This section does not require pathogen inactivation process developed spongiform encephalopathy, validation and routine control of specific requirements, such as scrapie, mad Cow disease and Creutzfeldt-Jakob disease. Its clauses include terms and definitions.
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Document preview — YY/T 0567.5-2011
National Standard of the People's Republic of China
- ICS
- 11.080.01
- Classification
- C 47
- Replacing
- YY/T 0567.2-2005
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
1 Scope
YY/T 0567 provisions of this section by aseptic processing of health care products to the production of sterile equipment product contact surfaces
Online sterilization (SIP) of the general requirements, and to provide authentication, validation, operation and control guidelines.
Note. SIP can be achieved through the use of steam or other gases or liquid sterilant. Appendix A gives the most common method --- Special steam sterilization online guide.
This section applies to the sterilizing agent is fed to the interior surface of the device so that the process of contact with the product.
This section does not apply to the device is disassembled to the sterilization process.
This section does not replace or substitute for national regulatory requirements, particularly those belonging to the requirements of the jurisdiction within the country or region, such as production management practices (GMPs) and/or the pharmacopoeia requirements.
This section does not require pathogen inactivation process developed spongiform encephalopathy, validation and routine control of specific requirements, such as scrapie, mad
Cow disease and Creutzfeldt-Jakob disease.
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.
GB 18281 (all parts) Sterilization of health care products - Biological indicators (ISO 11138, IDT)
GB 18282 (all parts) Sterilization of health care products - Chemical indicators (ISO 11140, IDT)
GB/T 19003 software engineering GB/T 19001-2000 apply to computer software guide (GB/T 19003-2008,
ISO /IEC 90003.2004, IDT)
GB/T 19972 Sterilization of health care products - Biological indicators selection, use and test results to determine Guide (GB/T 19972-
2005, ISO 14161.2000, IDT)
Characteristics of GB/T 19974 Sterilization of health care products and medical equipment sterilization factors set sterilization process, validation and routine control
General requirements (GB/T 19974-2005, ISO 14937.2000, IDT)
Aseptic processing Part 1 YY/T 0567.1 medical products. General requirements (YY/T 0567.1-2005, ISO 13408-1.
1998, IDT)
Aseptic processing YY/T 0567.4 health care products - Part 4. Online cleaning technology (YY/T 0567.4-2011,
ISO 13408-4.2005, IDT)
ISO 17665-1 Sterilization of health care products heat - Part 1. Medical device sterilization process development, validation and routine control of
Requirements (Sterilizationofhealthcareproducts-Moistheat-Part 1. Requirementsforthedevelopment, validationandroutinecontrolofasterilizationprocessformedicaldevices)
3 Terms and Definitions
YY/T 0567.1 and define the following terms and definitions apply to this document.
3.1 Blind deadleg
Unable to make sterilizing agents in the design of full-reach areas.
......
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
Similar standards
Editions of YY/T 0567.5
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0567.5-2011 | Aseptic processing of health care products - Part 5: Sterilization in place | current edition | Current |
| YY/T 0567.2-2005 | Aseptic processing of health care products - Part 5: Sterilization in place | previous edition | Superseded |
This page sells the current edition, YY/T 0567.5-2011. Earlier editions are listed for reference only.
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Related Standards
GB 18281.5-2015 — Sterilization of health care products -- Biological indicator -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
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
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