Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants PAS 15 sinks and reservoirs (SSRs) relevant

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Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants PAS 15 sinks and reservoirs (SSRs) relevant1 Scope The objective of this Technical Report is to provide interim Part by Part guidance on potential adjustments to various test methods within the 10993 series to account for the intentional release of soluble components or degradation products from absorbable medical devices. The content is intended to add clarity and present potentially acceptable approaches for reducing the possibility of erroneous or misleading results due to the nature of the