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SIST EN ISO 16297:2020 PDF — Milk - Bacterial count - Protocol for the evaluation of alternative m… — GOST Standards

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SIST EN ISO 16297:2020

Name: SIST EN ISO 16297:2020 — Milk - Bacterial count - Protocol for the evaluation of alternative methods (ISO 16297:2020)
SKU: SIST EN ISO 16297:2020
Price: 36000 RUB
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Milk - Bacterial count - Protocol for the evaluation of alternative methods (ISO 16297:2020)

Название (английский):

Milk - Bacterial count - Protocol for the evaluation of alternative methods (ISO 16297:2020)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 20
Дата публикации:: 11 февраля 2020 г.
ICS:: 67.100.10
Технический комитет:: KŽP - Agricultural food products

Тип поставки:

Full version36 000 ₽Read online 24h1 200 ₽Read online 72h1 800 ₽

Язык документа:

ruen

Срок поставки:4 раб. дн. (перевод)

Цена:36 000 ₽

Описание (английский):

This document specifies a protocol for the evaluation of instrumental alternative methods for total bacterial count in raw milk from animals of different species. NOTE The document is complementary to ISO 16140-2 and ISO 8196 | IDF 128 (all parts).

Abstract

Overview

Key Topics

This standard addresses the full validation workflow and technical requirements for alternative methods, including:

Scope and definitions - evaluation limited to instrumental alternative methods for total bacterial count in raw milk.
Transformation of results - procedures for converting instrument signals into comparable units.
Method description & checklist - documented description and operational checklist for the method under evaluation.
Measuring range - determination of lower and upper limits of quantification (LLOQ / ULOQ) and instrument signal linearity.
Carry‑over and stability - assessment of sample carry‑over and method stability over time.
Precision - evaluation of repeatability and reproducibility and analysis of factors affecting precision.
Comparison to anchor method - statistical evaluation of how well the alternative method estimates the anchor method, including scatter plots, outlier handling, and calculation of an accuracy profile.
Calculations & rating - how to compute performance metrics and rate the method attributes expressed in units of the anchor method.

The standard also aligns its approach with general accuracy and precision principles (referencing ISO 5725 series) and is complementary to broader method validation standards.

Applications

EN ISO 16297:2020 is used to validate and demonstrate fitness-for-purpose of rapid/automated bacterial counting methods in contexts such as:

Dairy processing and quality control laboratories implementing rapid microbial screening
Instrument manufacturers seeking formal validation for new devices
National food control and regulatory agencies assessing method acceptability
Accreditation bodies and test method developers performing method verification and inter-laboratory studies
Research groups comparing automated technologies to conventional plate counts

By following this protocol, laboratories and manufacturers can produce reproducible, auditable evidence that an alternative method performs acceptably compared with an established anchor method.

Related Standards

ISO 16140-2 - Validation of alternative microbiological methods (complementary)
ISO 8196 | IDF 128 - (all parts) - referenced in the scope
ISO 5725-1 / ISO 5725-2 - Accuracy (trueness and precision) principles

Keywords: EN ISO 16297:2020, ISO 16297:2020, milk bacterial count, alternative methods, total bacterial count, raw milk testing, method validation, accuracy profile, repeatability, reproducibility, anchor method.

Технические детали

SKU: SIST EN ISO 16297:2020

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Каталог

ISO 16297:2020

Действующий

Milk — Bacterial count — Protocol for the evaluation of alternative methods

Overview ISO 16297:2020 - Milk - Bacterial count - Protocol for the evaluation of alternative methods specifies a statistical and practical protocol for evaluating instrumental alternative methods us…

11 · PDF

19 800 ₽

ISO 5725-6:1994/Cor 1:2001

Действующий

Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in practice of accuracy va…

3 · PDF

5 400 ₽

SIST EN ISO 16140-2:2016/A1:2024

Действующий

Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (prop…

Overview EN ISO 16140-2:2016/A1:2024 is Amendment 1 to ISO 16140-2 and defines the protocol for validating alternative (proprietary) microbiological methods against an established reference method in…

32 · PDF

57 600 ₽

ISO 8196-1:2000

Отменён

Milk — Definition and evaluation of the overall accuracy of indirect methods of milk analysis — Part 1: Analy…

9 · PDF

16 200 ₽

SIST ISO 5725-1:2024

Действующий

Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definit…

Overview SIST ISO 5725-1:2024, "Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definitions," is published by the International Organization for…

25 · PDF

45 000 ₽

SIST ISO 5725-2:2020

Действующий

Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determina…

Overview SIST ISO 5725-2:2020 (equivalent to ISO 5725-2:2019) defines the basic method for estimating the precision of a standard measurement method by means of a collaborative interlaboratory experi…

69 · PDF

124 200 ₽

PDF

SIST EN ISO 16297:2020

Abstract

Overview

Похожие стандарты

Key Topics

Applications

Related Standards

Технические детали

ISO 16297:2020

Milk — Bacterial count — Protocol for the evaluation of alternative methods

ISO 5725-6:1994/Cor 1:2001

Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in practice of accuracy va…

SIST EN ISO 16140-2:2016/A1:2024

Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (prop…

ISO 8196-1:2000

Milk — Definition and evaluation of the overall accuracy of indirect methods of milk analysis — Part 1: Analy…

SIST ISO 5725-1:2024

Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definit…

SIST ISO 5725-2:2020

Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determina…