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Glossary Term
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ISO 16142 (Essential Principles of Safety and Performance of Medical Devices)

Definition

ISO 16142 is an international standard that identifies essential principles of safety and performance for medical devices and in vitro diagnostic (IVD) medical devices. It provides a structured approach to ensure devices are safe, perform as intended, and meet applicable regulatory requirements throughout their lifecycle.

Relevance to the MedTech Industry

ISO 16142 helps manufacturers and regulators ensure that medical devices are designed, developed, and maintained to meet universally recognized safety and performance criteria. This standard supports harmonization of regulatory frameworks globally, facilitating market access and enhancing patient safety.

Additional Information & Related Terms

Key Principles Outlined in ISO 16142

  1. Safety

    • Devices must not compromise the safety of patients, users, or others under normal use or foreseeable misuse.

  2. Performance

    • Devices must perform as intended and specified by the manufacturer, achieving clinical or diagnostic benefits.

  3. Risk Management

    • Manufacturers must identify, evaluate, and mitigate risks associated with device use, following the risk management process described in ISO 14971.

  4. Biocompatibility

    • Devices that contact human tissue or fluids must be biocompatible to avoid adverse biological reactions.

  5. Labeling and Instructions

    • Devices must include clear labeling and instructions to ensure proper use and handling.

  6. Sterility and Cleaning

    • Devices requiring sterility or reusability must meet sterility and cleaning validation requirements.

  7. Lifecycle Considerations

    • Safety and performance must be maintained throughout the device’s lifecycle, including handling, storage, and disposal.


Related Terms

  • ISO 14971: Complements ISO 16142 by providing risk management guidelines for medical devices.

  • Regulatory Submissions: ISO 16142 serves as a foundation for compliance in filings such as CE marking and FDA 510(k).

  • Biocompatibility Testing: A critical requirement for devices under ISO 16142 principles.

  • Post-Market Surveillance (PMS): Ensures continued compliance with safety and performance principles after market entry.


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