YY/T 1623-2018 Test method of effectiveness of sterilization processes for reusable medical devices
1 Scope
This standard specifies the test method for determining the effectiveness of sterilization processes for reusable medical devices. This standard is applicable to testing the effectiveness of established sterilization processes instead of validation of sterilization processes.
2 Normative references
The following referenced documents are indispensable for the application 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.
GB/T 6682 Water for analytical laboratory use - Specification and test methods
GB 18281.2 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
GB 18281.3 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
GB 18281.4 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
Pharmacopoeia of the People's Republic of China (Edition 2015) - Volume IV
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
bioburden
total number of microorganisms viable on or in a product and/or its package
3.2
colony forming unit; CFU
colony visible to the naked eye formed by microorganisms growing and propagating on a solid medium
3.3
inoculum
number (usually specified as CFUs) and type (genus and species) of viable microorganisms used to contaminate a given sample or device
3.4
sterilant
preparation that can kill all microorganisms (including bacteria and bacterial spores) to meet the sterilization requirements
3.5
sterile
state of being free of living microorganisms
3.6
recovery control
colony forming unit (CFU) recoverable from the interior or surface of each contaminated and dried device without sterilization
3.7
process test cycle
complete sterilization cycle that uses all parameters of the sterilization process as dictated by the manufacturer
Foreword II
Introduction III
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Test apparatus
6 Reagents
7 Procedure
