SIST EN ISO 16140-1:2016

Name: SIST EN ISO 16140-1:2016 — Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016)
SKU: SIST EN ISO 16140-1:2016
Price: 36000 RUB
Availability: InStock

Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016)

Название (английский):

Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 20
Дата публикации:: 8 сентября 2016 г.
ICS:: 01.040.07
Технический комитет:: KŽP - Agricultural food products

Тип поставки:

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

Язык документа:

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Срок поставки:4 раб. дн. (перевод)

Цена:36 000 ₽

Описание (английский):

ISO 16140-1:2016 defines general terms and definitions relating to method validation of microbiology in the food chain. It is applicable to the validation of methods for the analysis (detection or quantification) of microorganisms in - products intended for human consumption, - products intended for animal feeding, - environmental samples in the area of food and feed production, handling, and - samples from the primary production stage.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 16140-1:2016 - "Microbiology of the food chain - Method validation - Part 1: Vocabulary" is a CEN-endorsed ISO standard that defines general terms and definitions used for method validation of microbiological analyses in the food chain. It applies to methods for detection or quantification of microorganisms in:

products intended for human consumption,

products intended for animal feed,

environmental samples from food and feed production and handling, and

samples from primary production.

This part standardises the vocabulary needed to design, run and interpret validation studies, helping ensure consistent communication across laboratories, industry and regulators.

Key topics and technical terms

EN ISO 16140-1:2016 provides definitions and clarifications for core validation concepts, including:

Alternative method and reference method - scope and relationship for validation comparisons

Accuracy, bias, precision, and acceptability limit - statistical measures used to assess method performance

Accuracy profile and β‑expectation tolerance interval (β‑ETI) - approaches to represent quantitative method capacity

Detection level for qualitative methods (e.g., probability P = 0.95; theoretical reference of three viable cells in an inoculum)

Blind replicates, collaborator, interlaboratory study, and exclusivity study - terms for study design and performance evaluation

Measurement uncertainty concepts (combined standard deviation, coverage factor) and assigned value definitions The standard draws on related metrology guidance (JCGM sources) and cross-references microbiology-specific terminology (e.g., analyte as microorganism or toxin).

Applications

Preparing and interpreting method validation studies for microbiological tests (detection or enumeration)

Harmonising terminology in validation protocols, reports and regulatory submissions

Supporting quality assurance, method development, and accreditation documentation

Designing interlaboratory comparisons, single-laboratory validations, and verification exercises

By standardising vocabulary, it improves comparability of results between laboratories and supports robust decision-making in food safety testing and compliance.

Who uses this standard

Food and feed microbiology laboratories (public and private)

Method developers and manufacturers of proprietary test kits (alternative methods)

Accreditation bodies and regulatory agencies

QA/QC managers in food production and laboratory networks

Researchers designing validation and interlaboratory studies

Related standards

ISO 16140-2 (protocol for validation of alternative methods) - directly linked to Part 1 vocabulary

ISO 17468 (validation of standard methods) and ISO 17511 - referenced for measurement concepts and metrological traceability

Using EN ISO 16140-1:2016 ensures consistent, searchable terminology across validation documents, aiding clarity in method validation, food safety testing, and regulatory compliance.

SIST EN ISO 16140-1:2016

Abstract

Похожие стандарты

Overview

Key topics and technical terms

Applications

Who uses this standard

Related standards

Технические детали

ISO 16140-1:2016

Microbiology of the food chain — Method validation — Part 1: Vocabulary

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

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

SIST EN ISO 17468:2024

Microbiology of the food chain - Technical requirements and guidance on the establishment or revision of a st…

SIST EN ISO 17511:2021

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assig…