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ISO 16140-4:2020
Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory- 발행일 : 2020-07-09
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 34/SC 9 : Microbiology |
|---|---|
| 적용범위 | This document specifies the general principles and the technical protocols for single-laboratory validation of methods for microbiology in the food chain. The protocols in this document only validate the method for the laboratory conducting the study. This document is applicable to single-laboratory validation of: — methods used in the analysis (detection or quantification) of microorganisms in:
— methods for the confirmation or typing of microorganisms. This validation will replace only the confirmation or typing procedure of a specified method (see Annex G). This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms or their metabolites, to be determined on a case-by-case basis. Single-laboratory validation is required if an interlaboratory validation in accordance with ISO 16140-2 is not appropriate. Possible applications are: — validation of an in-house method; — method evaluation study in the validation process of a reference method in accordance with ISO 17468; — extension of the scope of an ISO 16140-2 validated method, e.g. category extension or test portion size; — modifications of existing methods. Single-laboratory validation is the second step in the standardization of a reference method (see ISO 17468). It is only applicable to methods that are fully specified with regard to all relevant parameters (including tolerances on temperatures and specifications on culture media) and that have already been optimized. |
| 국제분류(ICS)코드 | 07.100.30 : 식품 미생물학 |
| 페이지수 | 46 |
| Edition | 1 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 16140-4:2020/Amd 1:2024상세보기 | Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory — Amendment 1: Validation of a larger test portion size for qualitative methods | 2024-09-03 | 표준 |
| 2 | ISO 16140-4:2020상세보기 | Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory | 2020-07-09 | 표준 |
관련상품
- ISO 16140-3:2021/FDAmd 1 - Microbiology of the food chain — Method validation — Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory — Amendment 1: Validated identification methods of microorganisms — Technical protocol for verification
- ISO 16140-4:2020/FDAmd 2 - Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory — Amendment 2: Protocol for single-laboratory validation of identification methods of microorganisms
- ISO 16140-1:2016 - Microbiology of the food chain — Method validation — Part 1: Vocabulary
- ISO 16140-2:2016 - Microbiology of the food chain — Method validation — Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method
- ISO 16140-6:2019 - Microbiology of the food chain — Method validation — Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures
다른 사람이 함께 구입한 상품
- ISO 16140-3:2021 - Microbiology of the food chain — Method validation — Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory
- ISO 16140-6:2019 - Microbiology of the food chain — Method validation — Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures
- ISO 16140-1:2016 - Microbiology of the food chain — Method validation — Part 1: Vocabulary
- ISO 16140-2:2016 - Microbiology of the food chain — Method validation — Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method
- ISO 16140-5:2020 - Microbiology of the food chain — Method validation — Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods
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