INTE/ISO/TR 37137:2020
Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants.
Object and field of application
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.
General information
Committee Code
EN
Committee Name
Endoso
Sector
Salud
ICS
11.040.10
Correspondences
ISO TR 37137:2014
Organism
ISO
Edition
1
Approval Date
2020-06-30
Number of Pages
23
State
Vigente
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