BS EN ISO 16140-5 pdf free download

BS EN ISO 16140-5 pdf free download. Microbiology of the food chain — Method validation.
2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements 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. ISO 7218, Microbiology of food and animal feeding stuffs — General requirements and guidance for microbiological examinations 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 culture media, sample preparation, temperature, test duration) that can influence the test result. This allows the number of required laboratories to be reduced to a minimum of four. General concepts and considerations given in ISO 16140‑2 shall apply, unless explicitly excluded. The validation can be conducted against a reference method or, in the case of a quantitative method, without a reference method. The outcome of the validation study applies to: — any laboratory: if the four laboratories can be considered a “random sample” of independent laboratories from different organizations; — all laboratories within an organization: if the four laboratories can be considered a “random sample” of laboratories at different sites from one organization. 4.2 Validation against a reference method The validation protocol comprises two phases: — an in‑house validation study of the non‑proprietary method against the reference method carried out in the organizing laboratory (see ISO 16140‑1:2016, 2.45); — an interlaboratory study of the non‑proprietary method against the reference method carried out in different laboratories. The technical protocol for performing the in‑house validation study and the interlaboratory study are given in Clauses 5 and 6, depending upon whether the test method is qualitative or quantitative in nature. The selected factors for the factorial interlaboratory study should be relevant and applied to both the reference and the alternative method. 4.3 Validation without a reference method The validation protocol applies to the validation of quantitative methods only. It comprises two phases: — an in‑house validation study of the non‑proprietary method against the reference value carried out in the organizing laboratory; — an interlaboratory study of the non‑proprietary method against the reference value carried out in different laboratories. The technical protocol for performing the in‑house validation study and the interlaboratory study for quantitative methods are given in Clause 6. 5 Qualitative methods — Technical protocol for factorial interlaboratory validation 5.1 In‑house validation study The in‑house validation study is the part of the validation process that is performed in the organizing laboratory. It can be conducted in accordance with the conventional approach or the factorial approach, as described in ISO 16140‑4. An in‑house validation study can be used to demonstrate the performance of the method for the laboratory that conducted the study. It is the first step in the framework of general method validation. The in‑house validation study assesses the performance of the method across (food) categories, (food) types and (food) items, whereas the interlaboratory study assesses the performance of the method across laboratories.BS EN ISO 16140-5 pdf download.