GB 18279-2000 (English Version) Medical devices--Validation and routine control of ethylene oxide sterilization

Standard No.: GB 18279-2000
Language: Chinese, Available in English version
Release Date: 2000
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Status: Be replaced 2026-10
Replace By: GB 18279.1-2015; GB/T 18279.2-2015; GB 18279-2023
Latest: GB 18279-2023

Scope: This standard specifies the requirements and guidelines for the validation and routine control of the ethylene oxide (EO) sterilization process for medical devices. Special attention needs to be paid to specific trials with regard to safety, quality, and efficacy. For a specific product, it may exceed the scope of 4.2. Note 2: Although the purpose of writing this standard is to apply to the sterilization of medical devices, it is also applicable to other healthcare products. 2 This standard does not cover the quality assurance system, which must control all stages of production, including sterilization. 3 This standard does not address operator safety issues (see IEC 1010-2 for further information). EO is a toxic, flammable and explosive gas. Attention should be paid to my country's safety requirements and regulations on EO management and use, as well as my country's regulations on EO residue limits for medical devices and various products. 4 This standard does not include the technique of directly injecting EO or its mixed gas into a single product package for sterilization, nor does it include continuous sterilization. 5 This standard does not include analytical methods for the determination of residual levels of EO and/or its reaction products (see ISO 10993-7). 6 This standard does not include products that are adversely affected by EO or other EO residues generated during the sterilization process.

GB 18279-2000 history

2023 GB 18279-2023 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization
2015 GB 18279.1-2015 Sterilization of health care products.Ethylene oxide.Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
2000 GB 18279-2000 Medical devices--Validation and routine control of ethylene oxide sterilization