GB/T 15981-2021 Evaluating method for the efficacy of sterilization for disinfection equipment
1 Scope
This document specifies the test equipment, test procedures, evaluation provisions and precautions for the identification test for efficacy of sterilization for pressure steam sterilizer, dry heat sterilizer (cabinet), ethylene oxide sterilizer, low temperature steam formaldehyde sterilizer and hydrogen peroxide gas plasma sterilizer.
This document is applicable to the evaluation for efficacy of sterilization for pressure steam sterilizer, dry heat sterilizer (cabinet), ethylene oxide sterilizer, low temperature steam formaldehyde sterilizer and hydrogen peroxide gas plasma sterilizer.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GBZ 2.1 Occupational exposure limits for hazardous agents in the workplace - Part 1: Chemical hazardous agents
WS/T 649 Hygienic requirement for medical purpose-low temperature steam and formaldehyde sterilizers
WS/T 683 Requirements of microorganism for disinfection test
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
D value
time required to kill 90% of the total number of microorganisms in a specific test under set exposure conditions
3.2
carrier
support for test microorganisms
3.3
fully loaded
maximum allowable loading capacity placed in the manner specified in the manufacturer's manual when using disinfection equipment
3.4
process challenge device; PCD
specially designed device that simulates a sterilized article, is resistant to a specific sterilization process, and is used to evaluate the effectiveness of the sterilization process
4 Identification test for the efficacy of sterilization for disinfection equipment
4.1 Identification test for the efficacy of pressure steam sterilizer
4.1.1 Test apparatus
4.1.1.1 Bacterial tablet: bacillus stearothermo philus (ATCC 7953 or SSI K31 strain) tablet (cloth or filter paper), the amount of bacteria recovered is more than or equal to 1×105 CFU/ tablet, at 121°C± 0.5°C, the D value is no less than 1.5 min; self-contained biological indicators meeting the above requirements can also be used.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Identification test for the efficacy of sterilization for disinfection equipment
Annex A (Information) Reagent and medium formulation
GB/T 15981-2021 Evaluating method for the efficacy of sterilization for disinfection equipment
1 Scope
This document specifies the test equipment, test procedures, evaluation provisions and precautions for the identification test for efficacy of sterilization for pressure steam sterilizer, dry heat sterilizer (cabinet), ethylene oxide sterilizer, low temperature steam formaldehyde sterilizer and hydrogen peroxide gas plasma sterilizer.
This document is applicable to the evaluation for efficacy of sterilization for pressure steam sterilizer, dry heat sterilizer (cabinet), ethylene oxide sterilizer, low temperature steam formaldehyde sterilizer and hydrogen peroxide gas plasma sterilizer.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GBZ 2.1 Occupational exposure limits for hazardous agents in the workplace - Part 1: Chemical hazardous agents
WS/T 649 Hygienic requirement for medical purpose-low temperature steam and formaldehyde sterilizers
WS/T 683 Requirements of microorganism for disinfection test
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
D value
time required to kill 90% of the total number of microorganisms in a specific test under set exposure conditions
3.2
carrier
support for test microorganisms
3.3
fully loaded
maximum allowable loading capacity placed in the manner specified in the manufacturer's manual when using disinfection equipment
3.4
process challenge device; PCD
specially designed device that simulates a sterilized article, is resistant to a specific sterilization process, and is used to evaluate the effectiveness of the sterilization process
4 Identification test for the efficacy of sterilization for disinfection equipment
4.1 Identification test for the efficacy of pressure steam sterilizer
4.1.1 Test apparatus
4.1.1.1 Bacterial tablet: bacillus stearothermo philus (ATCC 7953 or SSI K31 strain) tablet (cloth or filter paper), the amount of bacteria recovered is more than or equal to 1×105 CFU/ tablet, at 121°C± 0.5°C, the D value is no less than 1.5 min; self-contained biological indicators meeting the above requirements can also be used.
Contents of GB/T 15981-2021
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Identification test for the efficacy of sterilization for disinfection equipment
Annex A (Information) Reagent and medium formulation
