GB 18278-2000

Abolished

Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization

医疗保健产品灭菌 确认和常规控制要求 工业湿热灭菌

Standard Type
GB
ICS
11.080
CCS
C47
Status
Abolished
Issue Date
2000-12-18
Implementation
2001-05-01
Centralized Committee
国家药监局
Issuing Authority
国家药监局

Application Summary AI generated

This standard specifies the requirements for the validation, process control, and routine monitoring of industrial moist heat sterilization of health care products. It is applied by medical device manufacturers and sterilization service providers to ensure the sterility of items such as surgical instruments, implants, and wound dressings processed in steam sterilizers. The standard is used in industrial sterilization facilities, not in clinical or laboratory settings, to establish and maintain effective sterilization cycles.

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.