ISO/TR 37137:2014

Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants

Publication date:   May 12, 2014

General information

60.60 Standard published   May 12, 2014

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

Technical Report

11.040.40   Implants for surgery, prosthetics and orthotics

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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.

Life cycle

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PUBLISHED
ISO/TR 37137:2014
60.60 Standard published
May 12, 2014