ISO TR 27877-2021 PDF

Full title and description

ISO/TR 27877:2021 — Statistical analysis for evaluating the precision of binary measurement methods and their results. This technical report presents and compares statistical approaches for assessing the precision (repeatability and reproducibility-type behaviour) of measurement methods that yield binary outcomes, and explains estimation procedures with worked examples to support collaborative studies and inter-laboratory evaluations.

Abstract

This technical report introduces five statistical methods for evaluating the precision of binary measurement methods and their results. The methods are grouped into two types: (1) methods where each laboratory repeatedly measures a single nominally identical sample, and (2) extensions where there are several sample levels. For each method the theory is summarised, recommended estimators are given, and real-case examples are provided; the report presents multiple illustrative cases and compares the methods’ characteristics.

General information

• Status: Published (Technical Report).
• Publication date: October 2021.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 03.120.30 (Application of statistical methods).
• Edition / version: Edition 1 (2021).
• Number of pages: 26.

Information above is drawn from the ISO bibliographic record for ISO/TR 27877:2021.

Scope

ISO/TR 27877:2021 provides guidance on statistical analysis to evaluate precision for measurement procedures producing binary (two-state) outcomes. It covers study designs based on repeated measurements by participating laboratories (single-level and multi-level/sample‑level designs), estimation of precision-related measures appropriate for binary data, and practical worked examples to illustrate application in collaborative studies. The document is intended as guidance (technical report), not as a prescriptive test method.

Key topics and requirements

• Definitions and statistical framework for precision assessment of binary measurement outcomes.
• Five statistical methods for estimating precision (two broad types: single‑sample repeated measures and multi‑level sample designs).
• Estimation procedures for repeatability‑ and reproducibility‑type measures adapted to binary results.
• Worked examples and illustrative cases (multiple real‑case scenarios) to demonstrate calculation and interpretation.
• Comparative discussion of the strengths, limitations and applicability of the presented methods.

Typical use and users

Primary users include laboratory statisticians, method developers, laboratories participating in inter‑laboratory or collaborative studies, accreditation bodies and metrology specialists who need to quantify the precision of tests or measurements that produce binary outcomes (e.g., presence/absence, positive/negative results). The guidance is useful when designing studies, estimating precision components from binary data, and supporting accreditation or validation activities (complementary to general laboratory competence standards).

Related standards

Key related documents and standards include the ISO 5725 series on accuracy (trueness and precision) of measurement methods and results (general principles and parts addressing practice and estimation), the International Vocabulary of Metrology (VIM/JCGM) for terminology and concepts in measurement, and ISO/IEC 17025 for laboratory competence and reporting practices. These standards provide complementary definitions, principles and accreditation context for applying ISO/TR 27877.

Keywords

binary measurement, precision, repeatability, reproducibility, concordance, sensitivity/specificity (measurement context), collaborative study, inter‑laboratory comparison, statistical methods, metrology.

FAQ

Q: What is this standard?

A: ISO/TR 27877:2021 is a technical report providing statistical guidance for evaluating the precision of measurement methods that produce binary (two‑state) results; it summarises methods, estimation procedures and illustrative examples.

Q: What does it cover?

A: It covers five statistical approaches (grouped into two types) for precision evaluation using data from collaborative studies, details on how to estimate proposed precision measures for binary outcomes, and comparisons and worked examples to aid practical application.

Q: Who typically uses it?

A: Laboratory statisticians, method developers, participating laboratories in inter‑laboratory studies, accreditation bodies and metrology experts involved with binary-result measurement methods. It supports study design, analysis and validation/ accreditation activities.

Q: Is it current or superseded?

A: ISO/TR 27877:2021 was published in October 2021 as a Technical Report and is the current ISO bibliographic entry for this document. Users should verify in the ISO catalogue or national standards bodies for any amendments or newer editions when needed.

Q: Is it part of a series?

A: It is a standalone technical report but is conceptually and practically related to the ISO 5725 series on accuracy of measurement methods and to other metrology guidance such as the VIM; these related documents provide broader principles and terminology that complement the report.

Q: What are the key keywords?

A: Binary measurement, precision, repeatability, reproducibility, concordance, collaborative study, statistical estimation.