This part of GB/T 18280 gives guidance on the requirements in Parts 1 and 2 of GB/T 18280 relating to dosimetry. Dosimetry procedures related to the development, validation and routine control of a radiation sterilization process are described.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 11137-1 Sterilization of Health Care Products — Radiation — Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
ISO 11137-2:2006 Sterilization of Health Care Products — Radiation — Part 2: Establishing the Sterilization Dose
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in ISO 11137-1, ISO 11137-2 and the following apply.
3.1
dosimetry system
interrelated elements used for determining absorbed dose, including dosimeters, instruments, associated reference standards and procedures for their use
[ISO/TS 11139:2005]
Foreword II Introduction IV 1 Scope 2 Normative References 3 Terms and Definitions 4 Measurement of Dose 5 Selection and Calibration of Dosimetry Systems 6 Establishing the Maximum Acceptable Dose 7 Establishing the Sterilization Dose 8 Installation Qualification 9 Operational Qualification 10 Performance Qualification 11 Routine Monitoring and Control Annex A (Informative) Mathematical Modelling Bibliography
1 Scope
This part of GB/T 18280 gives guidance on the requirements in Parts 1 and 2 of GB/T 18280 relating to dosimetry. Dosimetry procedures related to the development, validation and routine control of a radiation sterilization process are described.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 11137-1 Sterilization of Health Care Products — Radiation — Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
ISO 11137-2:2006 Sterilization of Health Care Products — Radiation — Part 2: Establishing the Sterilization Dose
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in ISO 11137-1, ISO 11137-2 and the following apply.
3.1
dosimetry system
interrelated elements used for determining absorbed dose, including dosimeters, instruments, associated reference standards and procedures for their use
[ISO/TS 11139:2005]
Contents of GB/T 18280.3-2015
Foreword II
Introduction IV
1 Scope
2 Normative References
3 Terms and Definitions
4 Measurement of Dose
5 Selection and Calibration of Dosimetry Systems
6 Establishing the Maximum Acceptable Dose
7 Establishing the Sterilization Dose
8 Installation Qualification
9 Operational Qualification
10 Performance Qualification
11 Routine Monitoring and Control
Annex A (Informative) Mathematical Modelling
Bibliography
