Overview - ISO 15197:2013 for blood‑glucose self‑testing
ISO 15197:2013 specifies requirements for in vitro blood‑glucose monitoring systems intended for self‑testing by lay persons to manage diabetes mellitus. The standard covers systems that measure glucose concentrations in capillary blood samples, sets out design verification procedures, and defines how manufacturers must validate performance with intended users. It is aimed at manufacturers, regulatory authorities and conformity assessment bodies responsible for assessing system performance.
Key topics and technical requirements
- System accuracy (bias and precision): Defines expectations for the analytical capability of a blood‑glucose monitoring system as a whole, expressed in terms accessible to lay users. System accuracy includes both trueness (bias) and measurement precision.
- Analytical performance evaluation: Requirements for measurement precision, influence quantities (interfering substances), reagent stability and performance testing procedures.
- Design, development and usability: Clauses on ergonomics, human factors, user verification and the documentation and instructions supplied to users.
- Metrological traceability: Obligations to establish traceability of assigned values for calibrators and control materials, aligned with ISO 17511.
- Safety and reliability testing: Tests for electrical safety, mechanical hazards, EMC, resistance to heat, moisture and vibration, and component integrity.
- User performance evaluation: Protocols for validating that lay users can achieve intended performance using the device and its instructions for use.
- Ancillary content and rationale: Annexes include possible interfering substances (Annex A), traceability chain (Annex B) and the rationale for performance requirements (Annex C).
Practical applications - who uses ISO 15197:2013
- Manufacturers and product developers: To design, verify and document meters and test systems for self‑monitoring of blood glucose (SMBG) and to prepare regulatory submissions.
- Regulatory authorities and conformity assessment bodies: To assess manufacturer claims, performance data, user validation studies and conformity with international requirements.
- Clinical laboratories and testing labs: To design independent performance evaluations and comparative studies.
- Usability and risk‑management teams: To align device ergonomics and instructions with ISO 62366 and ISO 14971 requirements referenced by the standard.
Related standards (normative references)
Typical cross‑references include: ISO 13485, ISO 14971, ISO 17511, ISO 18113‑1/4/5, ISO 23640 and relevant IEC standards for safety and EMC (e.g., IEC 61010 and IEC 61326). These referenced standards should be consulted alongside ISO 15197:2013 for a complete compliance strategy.
For product development or regulatory filing, consult the full ISO 15197:2013 text and its normative references to ensure complete, up‑to‑date compliance.
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