ISO/TR 37137:2014

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Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants

Published By	Publication Date	Number of Pages
ISO	2014-05	22

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, ISO

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Description

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.

Additional information

Published Code	ISO
Published By	International Organization for Standardization
Publication Date	2014-05
Pages Count	22
Language	France
Edition	1
File Size	368.6 KB
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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ISO/TR 37137:2014

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