GB 18282.1-2015

Abolished

Sterilization of health care products—Chemical indicator—Part 1: General requirements

医疗保健产品灭菌 化学指示物 第1部分:通则

Standard Type
GB
ICS
11.080.01
CCS
C47
Status
Abolished
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 18282.1-2015 specifies general requirements for chemical indicators used in sterilization processes for health care products. It applies to the design, performance testing, and classification of chemical indicators that monitor sterilization parameters such as temperature, time, and sterilant exposure in medical device manufacturing and healthcare facility sterilization cycles. This standard ensures consistent and reliable indicator performance across steam, ethylene oxide, and other sterilization methods.

Related Standards

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.