GSO ISO/TR 37137:2024

ISO/TR 37137:2014
Gulf Standard   Current Edition · Approved on 25 April 2024

Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants

GSO ISO/TR 37137:2024 Files

English 17 Pages
Current Edition Reference Language

GSO ISO/TR 37137:2024 Scope

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.

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