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.