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DS/ISO/TR 37137

2014 Edition, May 26, 2014

Complete Document

Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants



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Active, Most Current

EN
Additional Comments:
SAME AS ISO TR 37137
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Product Details:

  • Revision: 2014 Edition, May 26, 2014
  • Published Date: May 26, 2014
  • Status: Active, Most Current
  • Document Language: English
  • Published By: Dansk Standardiseringsrad (DS)
  • Page Count: 26
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

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.