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    Product safety: Electrical, mechanical, radiation, usability, software

    MEDICAL DEVICES

    IEC 60601-1 is the basic safety standard for medical electrical devices and systems. It is a risk-based standard.

    The IEC 60601-1 standard is essential for manufacturers or repair shops of electrically operated medical devices. The standard covers an essential part of compliance with the EU MDR and FDA requirements.

    By meeting the requirements of IEC 60601-1, a medical device meets the requirements for Basic Safety. This means that when the device is operating in normal condition or has a single fault condition, there are no hazards that would cause unacceptable risk to the patient or user.

    By meeting the requirements of the standard, a medical device also meets the requirements for Essential Performance. This refers to the performance of a clinical function other than basic safety, where loss or degradation beyond the specific limits causes an unacceptable risk.

    The IEC 60601-1 standard includes 420 pages and covers, e.g.:

    – Testing the equipment
    – Classification of the equipment (IEC 60601-1 classification)
    – Identification, marking and documents
    – Electrical safety
    – Usability
    – Radiation
    – Software and systems
    – Construction of the equipment
    – Electromagnetic compatibility

    The standard is a harmonized standard to the Medical Device Directive. It will be harmonized to the Medical Device Regulation ETA in 2024 as EN 60601-1

    The standard includes references to particular and collateral standards.

    IEC 60601-1 training

    Labquality provides IEC 60601-1 standard training, during which you will learn about the basic safety and essential performance of the standard, its content and requirements. Although the training mainly covers medical devices, it also briefly addresses IVD device safety standard 61010-1.

    The training starts with a part that is not safety standard specific but describes the standardization organizations, international and regional (EU, USA, Canada), how the standards are created and how they are implemented in the regulations.

    Inhalt

    • Why standard?
    • Standardization organizations
    • Regulatory requirements and standards
    • Main standards
    • Relationships with IEC standards
    • Introduction to IEC 60601-1
    • The future of IEC 60601-1 in brief
    • How do I read a standard
    • IEC 60601-1 requirements and tests
      • Usability
      • Software
      • Mechanics
      • EMC
      • Future
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    Trainer

    Zielgruppe

    Designers of medical electrical equipment (electronics / mechanics / radiation / usability / software), persons responsible for requirements, persons responsible for device risk management, persons responsible for the quality system.

    Nach diesem Training

    • You will understand the content of the standard and how to use it.
    • You will be able to combine the standard with other device-specific standards.
    • You will recognise the risks that the standard requires you to consider.
    • You will know how the standard requirements will soon change.

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    Die teilnehmende Organisation kann den Teilnehmer auf Wunsch kostenlos wechseln, indem sie dies vor der Veranstaltung schriftlich an:  koulutus@aurevia.com meldet. Die Teilnahmegebühr wird unmittelbar nach der Veranstaltung in Rechnung gestellt. Die Trainingseinheit wird dem Teilnehmer ca. eine Woche vor der Veranstaltung per E-Mail bestätigt. Labquality behält sich das Recht vor, die Schulung aufgrund einer zu geringen Teilnehmerzahl abzusagen.