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Glossary Term
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International Organization for Standardization (ISO)

Definition

The International Organization for Standardization (ISO) is an independent, non-governmental organization that develops and publishes international standards to ensure quality, safety, efficiency, and interoperability across various industries, including healthcare and medical devices. ISO standards are recognized globally and serve as benchmarks for regulatory compliance and best practices.

Relevance to the MedTech Industry

ISO establishes standardized frameworks and guidelines critical for the development, manufacturing, and quality assurance of medical devices. Compliance with ISO standards, such as ISO 13485 for quality management systems and ISO 14971 for risk management, ensures devices meet global safety and performance expectations, facilitating market access and regulatory approvals.

Additional Information & Related Terms

Key Standards Relevant to Medical Devices


Note: While the following standards play a pivotal role in ensuring all medical device are both safe and effective, there are a number of other standards for specific technologies and processes.

  1. ISO 13485: Specifies requirements for quality management systems in the design, manufacture, and servicing of medical devices.

  2. ISO 14971: Focuses on risk management for medical devices, emphasizing the identification, evaluation, and mitigation of potential risks.

  3. ISO 10993: Guides biological evaluation of medical devices, ensuring biocompatibility.

  4. ISO 62366: Provides usability engineering guidelines for improving device safety and effectiveness.

  5. ISO 14644: Establishes standards for cleanroom environments used in medical device manufacturing.


Related Terms

  • Quality Management System (QMS): Heavily influenced by ISO 13485, which provides the framework for device manufacturing.

  • Risk Management (ISO 14971): A critical process standardized by ISO for identifying and mitigating device risks.

  • Regulatory Compliance: ISO standards support global compliance, including FDA and EU MDR requirements.

  • Cleanroom Standards (ISO 14644): Ensures the manufacturing environment meets contamination control standards.

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