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ISO - TR 37137

Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants

active, Most Current
Organization: ISO
Publication Date: 15 May 2014
Status: active
Page Count: 22
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
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 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.

Document History

TR 37137
May 15, 2014
Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
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...

References

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