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