GB 18282.5-2015

Active

Sterilization of health care products—Chemical indicators—Part 5：Class 2 indicators for Bowie and Dick-type air removal tests

医疗保健产品灭菌化学指示物第5部分：用于BD类空气排除测试的二类指示物

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

GB 18282.5-2015 specifies the performance requirements and test methods for Class 2 chemical indicators used in Bowie and Dick-type air removal tests within steam sterilization cycles. It is applied in healthcare facilities and medical device manufacturing to verify that air has been effectively removed from pre-vacuum sterilizers, ensuring proper steam penetration. This standard is critical for validating sterilization processes in hospitals and industrial sterilization units.

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.