ISO-37137 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants

ISO-37137 - 1ST EDITION - CURRENT


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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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11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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Document Number

ISO/TR 37137:2014

Revision Level

1ST EDITION

Status

Current

Publication Date

May 15, 2014

Committee Number

ISO/TC 194