Reference number
ISO/TR 37137:2014
Technical Report
ISO/TR 37137:2014
Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
Edition 1
2014-05
Technical Report
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ISO/TR 37137:2014
64887
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Publicado (Edición 1, 2014)

ISO/TR 37137:2014

ISO/TR 37137:2014
64887
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CHF 96
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Resumen

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.

Informaciones generales

  •  : Publicado
     : 2014-05
    : Norma Internacional publicada [60.60]
  •  : 1
     : 17
  • ISO/TC 194
    11.040.40 
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