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]
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
ISO11137-1 医疗保健产品灭菌 辐射 第1部分:医疗器械灭菌过程的开发、确认和常规控制要 求 (Sterilization of health care products—Radiation—Part1:Requirementsfor development,
validationandroutinecontrolofasterilizationprocessformedicaldevices)
ISO11137-2:2006 医疗保健产品灭菌 辐射 第2部分:建立灭菌剂量(Sterilizationofhealth
careproducts—Radiation—Part2:Establishingthesterilizationdose)
GB/T 18280.3-2015 The following standards are cited：
GB/T 18280.3-2015 Cited by the following standards：
