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YY/T 1607-2018: Radiation sterilization of medical device--Method of dose setting
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1607-2018 | English | 379 |
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Radiation sterilization of medical device--Method of dose setting
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YY/T 1607-2018
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Basic data | Standard ID | YY/T 1607-2018 (YY/T1607-2018) | | Description (Translated English) | Radiation sterilization of medical device--Method of dose setting | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 19,190 | | Date of Issue | 2018-06-26 | | Date of Implementation | 2019-07-01 | | Regulation (derived from) | State Drug Administration Announcement No. 40 of 2018 | | Issuing agency(ies) | State Drug Administration | YY/T 1607-2018: Radiation sterilization of medical device--Method of dose setting---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Radiation sterilization of medical device--Method of dose setting
ICS 11.080.01
C47
People's Republic of China Pharmaceutical Industry Standard
Medical device radiation sterilization
Dose setting method
Published on.2018-06-26
2019-07-01 implementation
State Drug Administration issued
Content
Foreword III
1 Scope 1
2 Normative references 1
3 Abbreviations, terms and definitions 1
4 Improved Method 2 Application 3
5 Method for determining the dose setting improvement of the extrapolation factor from the positive score information obtained from the incremental dose experiment 2 3
6 Improved Method 2A Step 4
7 Step 7 of Improved Method 2B
8 Sterilization dose review 9
Appendix A (informative) Example 10
Reference 16
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200).
This standard was drafted. Shanghai Jinpengyuan Irradiation Technology Co., Ltd., Shanghai Fuxin Irradiation Technology Co., Ltd., Guangdong Medical Device Quality
Volume Supervision and Inspection Institute.
The main drafters of this standard. Chen Qiang, Huang Deqiu, Liu Zhiwei, Zhang Dingyan, Huang Hongxin, Liu Jiangping, Xu Haiying, Li Weiming, Fang Juanling, Gao Yang.
Medical device radiation sterilization
Dose setting method
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 article.
Pieces. 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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