YY/T 1613-2018Requirements for process characterization and control in radiation sterilization of medical devices (English PDF)
医疗器械辐照灭菌过程特征及控制要求
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 28, 2018
Implementation date
October 1, 2019
Scope
YY/T 1613-2018 is the English-translated version of 医疗器械辐照灭菌过程特征及控制要求.
YY/T 1613-2018 is the Chinese standard "Requirements for process characterization and control in radiation sterilization of medical devices".
Its scope clause reads: This standard specifies the characteristics and control requirements of the irradiation sterilization process of medical devices, and establishes and satisfies the gamma 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. Its clauses include terms and definitions.
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Document preview — YY/T 1613-2018
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 Installation Identification
- 5 Operation Identification
- 6 Performance Identification
- 7 Product and Process Specification
- 8 daily monitoring
- 9 Process Effectiveness Maintenance
- 10 Change Assessment
- Appendix A (Normative) Operational Identification
- Appendix B (Normative) Performance Identification
- Appendix C (informative) Uncertainty in daily dose monitoring
- Appendix D (informative) Radiation source equivalent arrangement
1 Scope
This standard specifies the characteristics and control requirements of the irradiation sterilization process of medical devices, and establishes and satisfies the gamma 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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 39 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 16841-2008Guide for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
- 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 18280.3-2015Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO/ASTM 51608 · ISO/ASTM 51702
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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
GB/T 16841-2008 — Guide for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
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