Standard No.:	YY/T 1623-2018
English Name:	Test method of effectiveness of sterilization processes for reusable medical devices
Chinese Name:	可重复使用医疗器械灭菌过程有效性的试验方法
Chinese Classification:	C47    Public medical equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.080.01 11.080.01    Sterilization and disinfection in general 11.080.01
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2018-09-21
Implemented on:	2019-9-26
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	165.0
Delivery:	via email in 1 business day

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