GB 18279.1-2015

Active

Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices

医疗保健产品灭菌环氧乙烷第1部分：医疗器械灭菌过程的开发、确认和常规控制的要求

Standard Type

ICS

11.080.01

CCS

C47

Status

Active

Issue Date

2015-12-10

Implementation

2017-01-01

Centralized Committee

国家药监局

Issuing Authority

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the requirements for the development, validation, and routine monitoring of ethylene oxide sterilization processes for medical devices. It is applied by medical device manufacturers and sterilization service providers to ensure that sterile products meet safety and efficacy standards. The standard is used in healthcare settings and regulatory compliance contexts to control sterilization quality and prevent contamination.

Related Standards

GB/Z 44877-2024 Sterilization of medical devices—Guidance on using parametric release for ethylene oxide sterilization process GB/T 16931-1997 Medical and classificational standard of winter sports for disabled athletes GB/T 16932.3-1997 Urine absorbing aids--Vocabulary--Part 3:Identification of product types GB/T 16932.2-1997 Urine absorbing aids--Vocabulary--Part 2:Products GB/T 16932.1-1997 Urine absorbing aids--Vocabulary--Part 1:Conditions of urinary incontinence GB/T 26373-2010 Hygienic standard for alcohol disinfectants GB/T 26371-2010 Hygienic standard for peroxide disinfectants GB/T 26370-2010 Hygienic standard for disinfectants with bromine

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.