YY/T 1733-2020 English PDF

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YY/T 1733-2020: Radiation sterilization of medical devices - Guide for dose mapping in irradiation processing facilities
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Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1733-2020	359	Add to Cart	4 days	Radiation sterilization of medical devices - Guide for dose mapping in irradiation processing facilities	Valid

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Basic data

Standard ID: YY/T 1733-2020 (YY/T1733-2020)
Description (Translated English): Radiation sterilization of medical devices - Guide for dose mapping in irradiation processing facilities
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C47
Classification of International Standard: 11.080.01
Word Count Estimation: 19,193
Date of Issue: 2020-09-27
Date of Implementation: 2022-06-01
Regulation (derived from): Announcement No. 108 (2020) of the National Medical Products Administration
Issuing agency(ies): State Drug Administration

YY/T 1733-2020: Radiation sterilization of medical devices - Guide for dose mapping in irradiation processing facilities

---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 devices - Guide for dose mapping in irradiation processing facilities People's Republic of China Pharmaceutical Industry Standards Released on 2020-09-27 Implementation of.2012-06-01 Issued by the National Medical Products Administration 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Prerequisite 2 5 Dose distribution test 3 6 Analysis of Dose Distribution Test Data 6 7 Uncertainty of measurement 6 8 Recording 7 Appendix A (informative appendix) Determine the equivalent dose area and the maximum and minimum dose area 8 Appendix B (informative appendix) Estimate the maximum and minimum doses according to routine monitoring dose 14 References 15

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 agency 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 Standardization Technical Committee for Disinfection Technology and Equipment (SAC/TC200). Drafting organizations of this standard. Shandong Weigao Group Medical Polymer Products Co., Ltd., Guangdong Medical Device Quality Supervision and Inspection Institute, Shanghai Jinpengyuan Irradiation Technology Co., Ltd., Shanghai Fuxin Irradiation Technology Co., Ltd. The main drafters of this standard. Yue Fangming, He Zhuohua, Chen Qiang, Huang Hongxin, Zhang Dingyan, Li Jun, Yu Haichu.

Introduction

The radiation sterilization process is carried out under a fixed path condition, and the processing load is automatically passed through the radiation field through a mechanical device or after the radiation has been sterilized. Before the start of the process, manually place the processing load in a predetermined position for static irradiation. Both forms are processed by the position and direction of the loading Reproducible control within specified limits. For some irradiation devices, an area can also be set in the radiation field for static irradiation, which is usually called radiation. Process according to the outside of the container. For the radiation sterilization process of medical devices, it is necessary to specify a minimum absorbed dose value to achieve the expected effect or meet the regulatory requirements, and A maximum absorbed dose value to ensure that products and materials still meet functional requirements or regulatory requirements after being irradiated. Therefore, the irradiation equipment and products should be Conduct dose distribution test research. The information obtained from the dose distribution test is used in the following areas. a) Describe the characteristics of the radiation sterilization process and evaluate the reproducibility of the absorbed dose value, which can be used as a component of operational qualification and performance qualification section; b) Determine the spatial distribution of the absorbed dose and the maximum and minimum absorbed dose area of the processing load. The processing load can be either the actual product or Simulate product composition; c) Establish the relationship between the dose at the routine monitoring position of processing and loading and the maximum dose and minimum dose; d) The influence of the interruption of the measurement process on the absorbed dose distribution and the maximum and minimum dose values; e) Assess the difference in the loading of adjacent processing, for example, the different density or loading mode of the product loaded in adjacent processing, resulting in the impact on the absorbent Dosage distribution and the influence of the maximum and minimum dose values. Radiation sterilization of medical devices Guide for Dose Distribution Testing of Irradiation Devices

1 Scope

This standard specifies the test requirements for radiation sterilization dose distribution of medical devices and the test data analysis method. This standard is applicable to the dose distribution test of gamma irradiation device, electron beam irradiation device, and X-ray (bremsstrahlung) irradiation device. This standard does not apply to the dose distribution test of unpackaged fluid products.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 16509 Guidelines for the Evaluation of Uncertainty in Dosimetry Measurement of Radiation Processing GB/T 16640 Radiation Processing Dose Measurement System Selection and Calibration Guidelines GB 18280.1 Sterilization radiation of medical and health care products Part 1.Development, validation and routine control of the sterilization process of medical devices Claim

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Note. Measure the absorbed dose by placing the dosimeter at the designated position in the processing load to make a one-dimensional, two-dimensional or three-dimensional absorbed dose distribution map. 3.2 A graph showing the response function of the dose measurement system. Note. The calibration curve represents the relationship between the indicated quantity and the corresponding measured value. In radiation processing standards, the dosimeter response is usually used as an indicator. 3.3 Note. This concept is also called the maximum/minimum dose ratio. 3.4 The area or discrete points of the equivalent absorbed dose in the processing load, the difference between the equivalent absorbed dose is measured in the irradiation process and the absorbed dose Within the range of statistical uncertainty. 3.6 A container that contains products that are irradiated by an irradiating device. 3.7 Run within the enclosure. 3.8 Produce products that meet the requirements of product specifications. 3.11 A homogeneous material with known radiation absorption and scattering characteristics used to establish the characteristics of the irradiation process. The characteristics of the irradiation process include scanning uniformity, depth Degree of dose distribution, production efficiency and dose reproducibility. 3.13 Note. The simulated product can be used as a substitute for the actual irradiated product in the operation appraisal, performance appraisal or routine process.

4 Prerequisites

4.1 Overview Installation qualification and calibration of the dose measurement system should be performed before the dose distribution test. 4.2 Installation appraisal 4.2.1 Before implementing the dose distribution test for the operation qualification and performance qualification of the irradiation device, it should be confirmed that the installation qualification has been completed. 4.2.2 For electron beam and X-ray irradiation devices, the installation qualification includes the beam characteristics (electron energy, average beam current, and when applicable, Scan width and scan uniformity) dosimetry test. 4.2.3 For gamma irradiation devices, it is not necessary to conduct dosimetry tests during the installation qualification period, but the activity and location of each radioactive source should be Confirm and record. 4.3 Calibration of the dose measurement system 4.3.1 Before use, the dose measurement system should be calibrated. The dose measurement system includes dosimeter measuring instruments and related reference Standards and procedures for use. The calibration is carried out in accordance with the procedure document that stipulates the calibration process and quality requirements. Refer to GB/T 16640 for the calibration method. 4.3.2 For the calibration of the instrument and equipment and the performance verification of the instrument and equipment between the two calibrations, follow GB/T 16640 and/or the operation of the instrument and equipment. Make a manual.

5 Dose distribution test

5.1 Run the qualification dose distribution test 5.1.1 In accordance with the requirements of GB 18280.1, implement the dose distribution test of the irradiation device to determine the absorbed dose distribution and the re-absorbed dose The characteristics of the irradiation device such as availability. It should be tested in accordance with formal verification procedures and should cover the expected operating range of the irradiated product. 5.1.2 Place the dosimeter in multiple processing loads from the reference material to the upper limit of the design volume of the irradiation container, and perform the dose of the irradiation device. Quantity distribution test. The number of processing loads should be large enough (3 or more) to determine the range of dose variation. Changes in operating parameters can affect For dose distribution irradiating devices, the operating parameters for performing dose distribution tests should cover the operating limits of the irradiated products. 5.1.2.1 For gamma or X-ray irradiation devices, the material density should be within the applicable density range of the irradiation device. When processing multiple densities At least two density dose distribution tests should be performed, using materials close to the lower limit and upper limit of the irradiating device’s use density range respectively. Line to evaluate the impact of density on the distribution and magnitude of absorbed dose. Users can consider increasing the dose distribution test of intermediate density to obtain better Multi-performance information. 5.1.2.2 For electron beam irradiation devices, one or more reference materials within the expected irradiated material density range shall be used for dose analysis. Cloth test. 5.1.2.3 Determine the absorbed dose distribution in the processing load for each product irradiation path and each set of process parameters in the radiation field. Note. Other ways to affect the absorbed dose distribution in a given processing load include. single-sided or double-sided irradiation in electron beam and X-ray devices, and gamma irradiation devices Use multiple source racks or change the position of the source racks. 5.1.2.4 For each processing load, arrange a sufficient number of dosimeters to determine the absorbed dose distribution. Band-shaped dosimeter can be used Spatial resolution of high dose distribution. The layout diagram of the dosimeter is shown in Figure 1. 5.1.2.5 Measure the dose at the same position in three or more repeated processing loads to determine the irradiation path of each product and each group of processing parameters The measured absorbed dose and the variation range of the absorbed dose distribution. a) For processing loads that pass through the radiation field, there should be a sufficient number of similar loads before and after the processing and loading of the dose distribution test. Workloading minimizes the difference in absorbed dose distribution during processing loading. b) Depending on the design of the irradiation device, additional dose distribution studies may be needed to determine the structure and loading of the processing during processing. The change of its density affects the dose and dose distribution. The effect of density change on dose and dose distribution can be determined by the following Evaluation method. continuous irradiation of two processing loads of different densities, the last processing load of the first density and the second Do the dose distribution test for the first processing load of one density, and compare these results with the homogeneous density dose distribution described in 5.1.2.5a) Compare the results obtained by the cloth test. c) If the results of the running qualification measurement show that the structure of the processing load and its density change may affect the dose and dose distribution If the product is affected, the impact on the actual product radiation processing should be evaluated during the performance appraisal, see 5.2.5. 5.1.2.6 After irradiation, retrieve and measure the response of each dosimeter, and evaluate the data according to the established procedures. 5.1.3 If there is a change in the irradiation device that affects the absorbed dose or the absorbed dose distribution, it should be assessed whether the dose distribution needs to be redone test. Note. GB 18280.1 provides additional guidance on the change of irradiation equipment and recommended change identification activities. 5.1.4 Use a mathematical model to determine the position of the dosimeter for the dose distribution test or predict the result of the dose distribution test. Note. See ASTM E2232-16. 5.2 Performance appraisal dose distribution test 5.2.1 Perform dose distribution tests on specific products and loading forms to determine the expected dose distribution during daily processing. International products or analog products with similar density, distribution and packaging methods to actual products. 5.2.2 If the routine monitoring position is used for process monitoring, the maximum dose, the minimum dose and the dose at the routine monitoring position should be established. Relationship. ......

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