GB 18280.1-2015 (English Version)

Standard No.: GB 18280.1-2015
Language: Chinese, Available in English version
Release Date: 2015
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest: GB 18280.1-2015
Replace: GB 18280-2000

Scope: This part of GB 18280 specifies the requirements for the development, validation and routine control of medical devices during radiation sterilization. This section applies to irradiation devices using the following radiation sources: a) using radionuclide cobalt-60 or cesium-137; b) electron beams emitted by electron accelerators; c) X-rays emitted by X-ray generators. This section does not specify requirements for the development, validation, and routine control of sterilization processes for the inactivation of spongiform encephalopathy pathogens such as scrapie, bovine spongiform encephalopathy, and Creutzfeldt-Jakob disease. Detailed regulations exist in specific countries for the processing of materials potentially contaminated with such pathogens. This section does not detail the regulatory requirements for designating a medical device as sterile. This part does not specify the quality management system for the control of the medical device production process. This section does not require biological indicators for use in the validation and monitoring of radiation sterilization, nor does it require the use of pharmacopoeial sterility tests for release of products. This part does not specify occupational safety requirements related to the design and operation of irradiation factories. This section does not specify the sterilization requirements for used and reprocessed medical devices.

GB 18280.1-2015 Referenced Document

GB 18280.2-2015 Sterilization of health care products.Radiation.Part 2: Establishing the sterilization dose
GB/T 19022-2003 Measurement management systems-Requirements for measurement processes and measruing equipment
GB/T 19973.1-2005 Sterilization of medical devices.Microbiological methods.Part 1: Estimation of population of microorganisms on products
GB/T 19973.2-2005 Sterilization of medical devices.Microbiological methods.Part 2: Tests of sterility performed in the validation of a sterilization process
YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes

2015 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
2000 GB 18280-2000 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization