GB/T 32310-2015 Sterilization of health care products—Chemical indicators—Guidance for selection,use and interpretion of results
GB/T 32310-2015 Sterilization of health care products—Chemical indicators—Guidance for selection,use and interpretion of results
Basic Information
Scope
1.1 This standard provides guidance for the selection, use, and interpretation of results of chemical indicators applied to the definition, validation, and routine monitoring and comprehensive control of sterilization processes. The chemical indicators in this standard are used to monitor one or more variables in the sterilization process by showing their exposure to the sterilization process through physical and/or chemical changes. These chemical indicators do not depend on the survival or inactivation of living organisms.
1.2 This standard does not apply to indicators used in the process of physically removing microorganisms (such as filtration).
1.3 This standard also does not apply to indicators used in combined processes [such as the combined process of cleaning the sterilizer or online cleaning (CIP) and online sterilization (SIP)].