References

Glossary key term references are listed below.

Key Term References

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There is currently 1 reference in this directory beginning with the letter O.
  • US (FDA and OLRC) regulations, US FDA guidance documents, European (EU) regulations, and IMDRF documents are available online for free.
  • International (ISO and IEC) standards are available for purchase from ISO or IEC, and in some cases, a preview or read-only version may be available online for free.
    • American (US) versions of international medical device standards are available for purchase from AAMI which offers significant discounts for AAMI members.
    • Other national versions of international standards are available for purchase from national standards bodies.

For an introduction to medical device standards and regulations, view online video Course 250 – Regulatory Compliance.