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Glossary Term
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ISO 60601 (Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance)

Definition

ISO 60601 is a family of international standards that specifies requirements for the safety, essential performance, and reliability of medical electrical equipment and systems. It addresses risks associated with electrical, mechanical, and thermal hazards and ensures compatibility with electromagnetic environments.

Relevance to the MedTech Industry

ISO 60601 ensures that medical electrical equipment is safe, effective, and reliable for clinical and home-use settings. It is a critical standard for risk mitigation, enhancing patient safety, and achieving regulatory compliance in global markets.

Additional Information & Related Terms

Key Sections of ISO 60601

  1. IEC 60601-1: General Requirements for Basic Safety and Essential Performance

    • Covers core safety and performance principles for all medical electrical equipment.

  2. IEC 60601-1-2: Electromagnetic Compatibility (EMC)

    • Specifies requirements for minimizing electromagnetic interference with other devices or systems.

  3. IEC 60601-1-6: Usability

    • Focuses on human factors engineering to ensure the device is user-friendly and minimizes use errors.

  4. IEC 60601-1-8: Alarm Systems

    • Provides guidelines for designing audible and visual alarms to alert users of critical conditions.

  5. IEC 60601-2-X Series

    • Includes specific requirements for different device types, such as ventilators, X-ray machines, or infusion pumps.


Examples of Applications

  • Patient Monitors: Devices used in hospitals and intensive care units to monitor vital signs.

  • Infusion Pumps: Systems that safely deliver precise amounts of medication to patients.

  • Diagnostic Imaging Equipment: X-ray machines, MRIs, and CT scanners that meet electrical and mechanical safety standards.

  • Home-Use Medical Devices: Electrical devices like nebulizers or portable oxygen concentrators designed for non-clinical environments.

Related Terms

  • Risk Management (ISO 14971): Complements ISO 60601 by guiding risk identification and mitigation in medical devices.

  • Electromagnetic Compatibility (EMC): A key component of ISO 60601-1-2, ensuring device reliability in electronic environments.

  • Human Factors Engineering (ISO 62366): Aligns with ISO 60601 usability standards to minimize user errors.

  • Regulatory Compliance: ISO 60601 compliance is critical for regulatory approvals in most jurisdictions.

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