YY/T 1608-2018Radiation sterilization of medical device—Sampling method for verification dose experiments and sterilization dose audits (English PDF)
医疗器械辐射灭菌验证剂量实验和灭菌剂量审核的抽样方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 26, 2018
Implementation date
July 1, 2019
Scope
YY/T 1608-2018 is the English-translated version of 医疗器械辐射灭菌验证剂量实验和灭菌剂量审核的抽样方法.
YY/T 1608-2018 is the Chinese pharmaceutical industry standard that gives a modification of the dose setting and dose auditing methods of GB 18280.2-2015 which reaches the required sterility assurance level with fewer product units.
It describes the verification dose experiment and the sampling plan for the sterilization dose audit, so that the same assurance is obtained at a lower cost in product. Issued on 26 June 2018, it has applied since 1 July 2019.
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Document preview — YY/T 1608-2018
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 Validation dose test and sample size for sterilization dose establishment/dose review
- Appendix A (Normative Appendix) Sample size for the implementation of the sampling plan and sampling plan Reference
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies an improved method for sterilization dose selection and review in GB 18280.2-2015, which ensures that the product is achieved.
At the same time as the sterility assurance level is expected, the number of required product units can be reduced, and the verification dose test and the sterilization dose review are described. Sample plan.
This standard applies to the selection and review of sterilization doses in GB 18280.2-2015 to ensure that the product meets the expected sterility assurance level. sampling.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB 18280.1-2015 Sterilizing radiation for health care products - Part 1. Development, validation and routines Control requirements (ISO 11137-1:2006, IDT)
GB 18280.2-2015 Sterilizing radiation for health care products - Part 2. Establishing a sterilizing dose (ISO 11137-2:2006, IDT)
GB/T 19973.2-2005 Microwaveological methods for the sterilization of medical devices - Part 2 (ISO 11737-2:1998, IDT)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Increasing dose augmentation
Measures to increase the sterilization dose based on the results of the sterilization dose audit.
3.2 Bioburden
The total number of viable microorganisms on the surface and/or inside of the product and/or sterile barrier system.
3.3 False positive
The turbidity of the test results is explained by the fact that the product or product share has microbial growth, while the microbial growth is due to contamination by foreign microorganisms.
The resulting or turbidity is the result of mutual influence of the product or product share and the test medium.
3.4 Product unit
A single medical device, product collection or component within a primary package.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 18280.1-2015Sterilization of health care products - Radiation - Part 1: Requirements for the development
- GB 18280.2-2015Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose
- GB/T 19973.2-2005Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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Related Standards
GB 18280.1-2015 — Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
GB 18280.2-2015 — Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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