Standard No.:	GB 4789.45-2023
English Name:	National food safety standard - General rules for verification of microbial test methods
Chinese Name:	食品安全国家标准 微生物检验方法验证通则
Chinese Classification:	X09    Hygiene, safety and labor protection
Professional Classification:	GB    National Standard
Source Content Issued by:	NHC; SAMR
Issued on:	2023-9-6
Implemented on:	2024-9-6
Status:	valid
Superseding:	GB 4789.35-2016 National food safety standard -Microbiological examination of food-Examination of lactic acid bacteria
Target Language:	English
File Format:	PDF
Word Count:	8500 words
Translation Price(USD):	255.0
Delivery:	via email in 1 business day

GB 4789.45-2023 National food safety standard - General rules for validation of microorganism examination methods 1 Scope This standard specifies the general requirements for validation of microorganism examination methods in the national food safety standard. This standard is applicable to the validation during the formulation and revision of microorganism examination methods in the national food safety standard. 2 Terms and definitions 2.1 method validation test activity which provides objective and valid evidence to prove that the performance parameters of the analytical method meet the intended use of the method 2.2 qualitative method method for testing the presence of a target microorganism in a sample 2.3 quantitative method method for determining the number or concentration of target microorganisms in a sample 2.4 reference method conventional method for culturing microorganisms, which is recognized or widely accepted 2.5 sensitivity ability of the qualitative method to be validated to detect target microorganisms from a sample 2.6 inclusiveness ability of the method to be validated to detect target microorganisms 2.7 exclusivity anti-interference ability of the method to be validated against non-target microorganisms 2.8 accuracy degree of consistency between the test results obtained by the quantitative method and the true values for a sample 2.9 specimens part derived from a sample, used for test, and capable of reflecting the characteristics of the sample 2.10 factional detection level contamination level of samples when a set of parallel samples is tested with the qualitative method (probability of detection: 25% to 75%) 2.11 50% limit of detection (LOD50) concentration of target microorganisms in the sample when the probability of detection for the qualitative method is 50% 2.12 relative limit of detection (RLOD) ratio of LOD50 for the method to be validated to that for the reference method in case a reference method is available at the time of validation 2.13 paired/unpaired analysis in case two qualitative methods are used to simultaneously test a sample: if the enrichment method used in the first step is the same, the same specimen obtained from the sample may be used for analysis, which is called "paired analysis"; if the methods used in the first step are different, different specimens obtained from the sample are used for separate analysis, which is called "unpaired analysis".

Foreword i 1 Scope 2 Terms and definitions 3 General requirements for validation of microorganism examination methods 3.1 Selection of performance parameters 3.2 Selection of representative foods 3.3 Requirements for samples for validation 3.4 Requirements for data processing 4 Validation of performance parameters concerning microorganism examination methods 4.1 Sensitivity 4.2 Inclusiveness and exclusivity 4.3 Accuracy Annex A Classification table of food samples for validation of microorganism examination methods Annex B Method for calculating sensitivity Annex C Method for calculating the accuracy of in-house validation Annex D Method for calculating the accuracy of interlaboratory validation