Overview
EN ISO 15197:2015 is the CEN-adopted version of ISO 15197:2013 and defines requirements for in vitro blood‑glucose monitoring systems intended for self-testing by lay persons in the management of diabetes mellitus. The standard covers design, verification and performance validation so that manufacturers, regulators and conformity assessment bodies can assess device safety, reliability and user performance.
Key topics and technical requirements
- Design and development: general design controls, ergonomics, human factors and user‑centric requirements to ensure lay users can operate systems safely.
- Metrological traceability: requirements for traceability of measurement results to recognized reference methods.
- Safety and risk management: integration with risk-management processes (reference to ISO 14971) and protection against electrical, mechanical and environmental hazards.
- Performance and reliability testing: environmental exposure limits (temperature, humidity), electromagnetic compatibility, vibration/shock resistance and component robustness.
- Analytical performance: requirements for measurement precision, system accuracy, influence of interfering substances and stability of reagents and materials.
- User verification and user performance evaluation: procedures and acceptance criteria for validating system performance when used by intended lay users, including human factors evaluation and instructions for use (IFU) assessment.
- Information supplied by manufacturer: required performance characteristics, labeling, IFU options and claims that must be supported by data.
- Regulatory linkage: informative Annex ZA maps the standard to essential requirements of EU Directive 98/79/EC for in vitro diagnostic devices.
Applications and who uses it
EN ISO 15197:2015 is used by:
- Manufacturers of blood‑glucose meters and test strips for product design, verification testing, clinical validation and IFU development.
- Regulatory authorities and notified bodies assessing conformity and pre-market dossiers.
- Conformity assessment bodies performing performance and safety audits.
- Clinical laboratories, procurement teams and healthcare organizations evaluating products for clinical suitability and patient self‑management programs.
- Design and quality teams aligning product development with ISO 13485 (quality management) and ISO 14971 (risk management).
Related standards
- ISO 13485 (medical device quality management)
- ISO 14971 (risk management for medical devices)
- ISO 17511, ISO 18113 series (metrology and labelling)
- IEC standards for safety and EMC referenced in the normative annexes
EN ISO 15197:2015 is essential for ensuring that consumer-facing blood‑glucose monitoring systems deliver reliable, traceable and user‑validated results for diabetes self‑management.