GB/T 18282.6-2026

Upcoming

Sterilization of health care products—Chemical indicators—Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers

医疗产品灭菌 化学指示物 第6部分:用于小型蒸汽灭菌器性能测试的二类指示物和过程挑战装置

Standard Type
GBT
ICS
11.080.01
CCS
C47
Status
Upcoming
Issue Date
2026-01-28
Implementation
2027-08-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

This standard specifies the requirements for Type 2 chemical indicators and process challenge devices used to verify the performance of small steam sterilizers in healthcare settings. It is applied during the routine testing and validation of benchtop or portable steam sterilizers, such as those used in dental clinics, outpatient surgery centers, and small hospital departments. The standard ensures that these devices reliably detect sterilization failures by mimicking the most difficult conditions for steam penetration and heat distribution within the sterilizer chamber.

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.