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YY/T 1613-2018 English PDF

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YY/T 1613-2018: Requirements for process characterization and control in radiation sterilization of medical devices
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Basic data

Standard ID YY/T 1613-2018 (YY/T1613-2018)
Description (Translated English) Requirements for process characterization and control in radiation sterilization of medical devices
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C47
Classification of International Standard 11.080.01
Word Count Estimation 42,48
Date of Issue 2018-09-29
Date of Implementation 2019-10-01
Quoted Standard GB/T 16841-2008; GB 18280.1-2015; GB 18280.2-2015; GB/T 18280.3-2015; ISO/ASTM 51608; ISO/ASTM 51702
Regulation (derived from) State Drug Administration Announcement No. 72 of 2018
Issuing agency(ies) State Drug Administration
Summary This standard specifies the characteristics and control requirements of the irradiation sterilization process of medical devices, and puts forward specific requirements for establishing and satisfying the installation identification, operation identification, performance identification and routine control of ��, electron beam and X-ray irradiation devices in GB 18280.1-2015. . This standard applies to the irradiation sterilization process of medical device products.

YY/T 1613-2018: Requirements for process characterization and control in radiation sterilization of medical devices


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Requirements for process characterization and control in radiation sterilization of medical devices ICS 11.080.01 C47 People's Republic of China Pharmaceutical Industry Standard Medical device irradiation sterilization process characteristics and control requirements Published on.2018-09-28 2019-10-01 implementation State Drug Administration issued

Content

Foreword I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Installation Identification 3 5 Operation Identification 4 6 Performance Identification 6 7 Product and Process Specification 7 8 daily monitoring 8 9 Process Effectiveness Maintenance 14 10 Change Assessment 15 Appendix A (Normative) Operational Identification 16 Appendix B (Normative) Performance Identification 24 Appendix C (informative) Uncertainty in daily dose monitoring 32 Appendix D (informative) Radiation source equivalent arrangement 37 Reference 39

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. Shandong Weigao Group Medical Polymer Products Co., Ltd., Guangdong Medical Device Quality Supervision and Inspection Institute, Zhongjin Irradiation Co., Ltd. The main drafters of this standard. Yue Fangming, Wang Wenrong, Xing Lizhen, Chen Qiang, Jiang Yan. Medical device irradiation sterilization process characteristics and control requirements

1 Scope

This standard specifies the characteristics and control requirements of the irradiation sterilization process of medical devices, and establishes and satisfies the γ and electricity in GB 18280.1-2015. The specific requirements for installation identification, operation identification, performance identification and routine control of the beamlet and X-ray irradiation devices are presented. This standard applies to the irradiation sterilization process of medical device products.

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/T 16841-2008 Dosimetry guidelines for electron beam radiation processing equipment with energy of 300keV~25MeV (ISO /ASTM 51649.2005, IDT) 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 18280.3-2015 Sterilizing radiation for health care products - Part 3. Guidelines for dose measurement (ISO 11137-3.2006, IDT) ISO /ASTM51608 Radiation agent for X-ray (dremophilic) equipment for irradiation processing between 50 keV and 7.5 MeV energy Measurement protocol [PracticefordosimetryinanX-ray(bremsstrahlung) facilityforradiationprocessing atenergiesbetween50keVand7.5MeV] ISO /ASTM51702 Code of Practice for Dosimetry in Gamma Radiation Devices for Radiation Processing (Practicefordosimetryina Gammafacabilityforradiationprocessing)

3 Terms and definitions

The following terms and definitions as defined in GB 18280.1-2015 and GB 18280.2-2015 apply to this document. 3.1 Basic master time basecycletime The cycle time selected by each product processing group. 3.2 Dose unevenness doseuniformity A measure of the change in dosage within the processing load. 3.3 Dose area dosezone A statistically equivalent area of the dose within the irradiation vessel.

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