ISO/TS 23367-1:2022 PDF

Name: ISO/TS 23367-1:2022 — Nanotechnologies — Performance characteristics of nanosensors for chemical and biomolecule detection — Part 1: Detection performance
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Nanotechnologies — Performance characteristics of nanosensors for chemical and biomolecule detection — Part 1: Detection performance

Название (английский):

ISO/TS 23367-1:2022

Nanotechnologies — Performance characteristics of nanosensors for chemical and biomolecule detection — Part 1: Detection performance

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 10
Дата публикации:: 13 декабря 2022 г.
Издание:: ISO TS 23367 edition 1 version 1
ICS:: 07.120

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Описание (английский):

This document describes the performance characteristics necessary to evaluate the detection performance of nanosensors for chemical and biomolecule detection. This document does not cover the analytical performance characteristics or the performance evaluation procedure of a specific sensor.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO/TS 23367-1:2022 - Nanotechnologies - Performance characteristics of nanosensors for chemical and biomolecule detection - Part 1: Detection performance defines the detection performance characteristics needed to evaluate nanosensors used for chemical and biomolecule detection. The technical specification standardizes terminology (e.g., analyte, measurand, nanosensor) and describes how to quantify detection performance. It does not cover analytical performance characteristics or the performance-evaluation procedure for a specific sensor.

Key Topics

Detection performance - ability of an assay using a nanosensor to determine presence of an analyte above a cut-off value.

Detection sensitivity - probability the assay scores positive when the analyte is present; expressed as TP / (TP + FN).

Detection specificity - probability the assay scores negative when the analyte is absent; expressed as TN / (TN + FP).

Detection signal ratio - ratio of averaged signal intensity of true positive samples to averaged signal intensity of true negative samples (Iaveraged,TP / Iaveraged,TN).

Terms and definitions - standardized vocabulary for nanosensor performance (e.g., analyte, nanosensor, performance characteristic).

Informative annexes - Annex A discusses general performance evaluation concepts (verification vs validation); Annex B addresses limitations of existing detection characteristics for nanosensors.

Applications

ISO/TS 23367-1:2022 is intended for contexts where nanosensors are used to detect chemicals or biomolecules, including:

In vitro diagnostics and healthcare (biomarker and infectious disease detection)

Environmental monitoring (pollutant and biohazard surveillance)

Food safety and quality control (detection of contaminants and pathogens)

Industrial process control and quality assurance

The standard helps characterize how well a nanosensor distinguishes positive from negative samples and documents performance claims for regulatory submissions, product specifications, and comparative testing.

Who should use this standard

Nanosensor developers and manufacturers seeking to define and report detection performance

Test laboratories and validation teams performing detection studies on nano-enabled sensors

Regulatory bodies and procurement specialists evaluating nanosensor suitability for intended use

R&D teams and quality managers integrating nanosensors into clinical, environmental, or food-safety workflows

Related standards

Normative references cited in ISO/TS 23367-1:2022 include:

ISO/IEC Guide 99:2007 (VIM - metrology vocabulary)

ISO 16604:2004 (protective clothing test methods)

ISO 17511:2020 (metrological traceability for in vitro diagnostics)

ISO 18113-1:2022 (labelling requirements for in vitro diagnostic devices)

By standardizing detection sensitivity, specificity and signal-ratio metrics for nanosensors, ISO/TS 23367-1:2022 supports consistent performance reporting and comparison across nanotechnology-enabled detection devices.

ISO/TS 23367-1:2022 PDF

Abstract

Похожие стандарты

Overview

Key Topics

Applications

Who should use this standard

Related standards

Технические детали

ISO 16604:2004

Clothing for protection against contact with blood and body fluids — Determination of resistance of protectiv…

ISO 17511:2020

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

ISO 18113-1:2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, d…