EN ISO 10993-9 Biological Evaluation of Medical Devices - Framework for Identification and Quantification of Potential Degradation Products

This standard provides general guidelines for the systematic assessment of potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information from these studies can be used in the biological assessment described in the ISO 10993 series. ISO 10993-9 considers both non-absorbable and absorbable materials.

This standard applies to both materials designed to degrade in the body and materials not intended to degrade.

This standard does not apply to:

• Evaluation of deterioration caused by purely mechanical processes; methodologies for the production of such decomposition product are described in specific product standards, where available;
  NOTE: Purely mechanical degradation causes mostly particulate matter. Although this is beyond the scope of this document, such degradation products may elicit a biological response and may be subject to biological evaluation as described in other parts of ISO 10993.
• Leakable components without decomposition products;
• Medical device or components that do not come into direct or indirect contact with the patient's body.
   

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