YY/T 1607-2018Radiation sterilization of medical device—Method of dose setting (English PDF)
医疗器械辐射灭菌剂量设定的方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 26, 2018
Implementation date
July 1, 2019
Scope
YY/T 1607-2018 is the English-translated version of 医疗器械辐射灭菌剂量设定的方法.
YY/T 1607-2018 is the Chinese pharmaceutical industry standard that gives a modification of methods 2A and 2B of GB 18280.2-2015, which reduces the number of dose increments needed to reach the required sterility assurance level.
It applies to products whose bioburden is low or whose organisms are of low radiation resistance and whose history supports that, and not to products where the bioburden is absent or unknown. Issued on 26 June 2018, it has applied since 1 July 2019.
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Document preview — YY/T 1607-2018
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 Abbreviations, terms and definitions
- 4 Improved Method 2 Application
- 5 Method for determining the dose setting improvement of the extrapolation factor from the positive score information obtained from the incremental dose experiment
- 6 Improved Method 2A Step
- 7 Step 7 of Improved Method 2B
- 8 Sterilization dose review
- Appendix A (informative) Example 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 methods 2A and 2B of GB 18280.2-2015, which can reduce the increase in the minimum dose.
The number of sets of doses that achieve the desired level of sterility assurance.
This standard applies to products with low bioburden or low radiation resistance and proven to be consistent with historical levels. Not applicable to biological negative Contains products that have not been evaluated.
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 18280.2-2015 Sterilizing radiation for health care products - Part 2. Establishing a sterilizing dose (ISO 11137-2:2006, IDT)
GB/T 18280.3-2015 Sterilizing radiation for health care products - Part 3. Guidelines for dose measurement (ISO 11137-3:2006, IDT)
3 Abbreviations, terms and definitions
The following abbreviations, terms and definitions apply to this document.
3.1 A value
Adjust the median ffp down to the dose of FFP.
3.2 CD*
In the verification dose experiment of Method 2, the number of positives obtained from the sterility test of 100 product units.
3.3 D*
The product unit is taken from a given production batch, and an incremental dose experiment is performed to obtain the dose from the experiment.
3.4 D*
The initial estimated dose of 10^-2 SAL was achieved for the test product.
Note. This value is generally the median of the three d* values for a given product.
3.5 D**
The test product test reached a final estimated dose of 10^-2 SAL, which was used to calculate the sterilization dose.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.
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Related Standards
GB 18280.2-2015 — Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose
GB/T 18280.3-2015 — Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimeter aspects
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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YY/T 1607-2018
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