MedTech Terms
    The authoritative reference
    Glossary

    All MedTech Terms

    513 sourced definitions covering the regulatory, quality, software, and cybersecurity vocabulary of modern medical devices.

    Showing 1–24 of 25

    Standards

    ASTM F2503

    Standard practice for marking medical devices and other items for safety in the magnetic resonance environment.

    Standards

    Essential Performance

    Performance of a clinical function whose loss or degradation would result in unacceptable risk.

    Standards

    Harmonised Standards

    European standards cited by reference in the Official Journal of the EU that give manufacturers a presumption of conformity with corresponding legal requirements.

    Standards

    ICH E6(R3) Good Clinical Practice(E6(R3))

    aka ICH GCP R3

    ICH Good Clinical Practice revision with Principles and Annex 1 adopted in January 2025 and Annex 2 in June 2026.

    Standards

    IEC 60601-1

    General requirements for basic safety and essential performance of medical electrical equipment.

    Standards

    IEC 60601-1-2

    EMC requirements for medical electrical equipment.

    Standards

    IEC 60825

    Standard for safety of laser products, including laser-based medical devices.

    Standards

    IEC 62304

    Lifecycle requirements for medical device software.

    Standards

    IEC 62366-1

    Application of usability engineering to medical devices.

    Standards

    IEC 82304-1

    Standard for health software products - covering general requirements for product safety.

    Standards

    ISO 10993-1

    Biological evaluation of medical devices within a risk management process.

    Standards

    ISO 11135

    Standard for development, validation, and routine control of ethylene oxide (EO) sterilization.

    Standards

    ISO 11137

    Standard for radiation sterilization of healthcare products.

    Standards

    ISO 11607-1/-2

    Standards for sterile barrier systems for terminally sterilized medical devices.

    Standards

    ISO 13485

    International standard for medical device quality management systems.

    Standards

    ISO 14155

    Good clinical practice for clinical investigations of medical devices.

    Standards

    ISO 14971

    International standard for the application of risk management to medical devices.

    Standards

    ISO 15223-1 Symbols

    Recognized graphical symbols for labels, labeling, and information supplied with medical devices.

    Standards

    ISO 17511

    ISO standard specifying requirements for establishing metrological traceability of values assigned to calibrators, controls, and human samples for IVD measurement procedures.

    Standards

    ISO 17665

    Standard for moist heat (steam) sterilization of medical devices.

    Standards

    ISO 20417

    Standard for information to be supplied by the manufacturer of medical devices.

    Standards

    ISO 22301

    Standard for business continuity management systems.

    Standards

    ISO/IEC 23894

    Guidance on AI-specific risk management for organizations developing or using AI systems.

    Standards

    ISO/TR 24971

    Guidance on the application of ISO 14971 to medical devices.