International Standard
ISO/TR 37137:2014
Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
Reference number
ISO/TR 37137:2014
Версия 1
2014-05
International Standard
Предпросмотр
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ISO/TR 37137:2014
64887
недоступно на русском языке
Опубликовано (Версия 1, 2014)

ISO/TR 37137:2014

ISO/TR 37137:2014
64887
Формат
Язык
CHF 96
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Тезис

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.

Общая информация

  •  : Опубликовано
     : 2014-05
    : Опубликование международного стандарта [60.60]
  •  : 1
  • ISO/TC 194
    11.040.40 
  • RSS обновления

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