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    • Home
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    • Implants For Surgery, Prosthetics And Orthotics
    • ISO/TR 37137:2014

    Codes & Standards - Purchase

    ISO/TR 37137:2014

    Cardiovascular biological evaluation of medical devices -- Guidance for absorbable implants
    SKU: iso_064887_158308 Published by ISO Publication Year 2014 1 Edition 17 pages

    Product Details

    • Overview
    The objective of ISO/TR 37137:2014 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 absorbable material. All suggestions should be considered as preliminary and subject to change, with final dispositions implemented through direct modification to the respective parts of ISO 10993. Thus, interim adoption of any of the described adjustments requires an accompanying written justification.

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