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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- 발행일 : 2019-11-12
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 34/SC 9 : Microbiology |
|---|---|
| 적용범위 | This document specifies the general principle and the technical protocol for the validation of alternative confirmation methods for microbiology in the food chain. This document compares the result of the alternative confirmation method against the confirmation procedure of a reference method or, if needed, a reference confirmation method (e.g. whole genome sequencing). This document is applicable to the validation of alternative confirmation methods used for the analysis (detection or quantification) of isolated microorganisms in: — products intended for human consumption; — products intended for animal feeding; — environmental samples in the area of food and feed production, handling; — samples from the primary production stage. Validated alternative confirmation methods can be used to replace (partly or completely) the confirmation procedure described in: — the reference method; — an alternative method validated in accordance with ISO 16140-2 only if one of the isolation agars specified in the validation study of the alternative confirmation method is used. This document is also applicable to the validation of alternative typing methods, where the reference method can be, for example, a serological method (e.g. serotyping of Salmonella) or a molecular method (e.g. typing of Shiga toxin-producing E. coli). This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, to be determined on a case-by-case basis. Validation studies in accordance with this document are primarily intended to be performed by organizations or expert laboratories involved in method validation, but can also be used by a single laboratory, especially when performing in-house validation under certain conditions (see ISO 16140-4). |
| 국제분류(ICS)코드 | 07.100.30 : 식품 미생물학 |
| 페이지수 | 25 |
| Edition | 1 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 16140-6:2019상세보기 | Microbiology of the food chain — Method validation — Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures | 2019-11-12 | 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 16140-2:2016 - Microbiology of the food chain — Method validation — Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method
- ISO 16140-1:2016 - Microbiology of the food chain — Method validation — Part 1: Vocabulary
- ISO 16140-4:2020 - Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory
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 16140-1:2016 - Microbiology of the food chain — Method validation — Part 1: Vocabulary
- ISO 16140-4:2020 - Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory
- 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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