Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
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.
ISO/TR 37137:2014 provides interim, part-by-part guidance to adapt biological evaluation methods (the ISO 10993 series) for intentionally absorbable implants used in cardiovascular applications. The Technical Report focuses on managing the effects of intentionally released soluble components and degradation products so that standard biocompatibility and hemocompatibility test results are not erroneous or misleading. Recommendations are provisional; any interim adjustments require a documented written justification and may later be incorporated into the respective ISO 10993 parts.
Стандарты, упомянутые в описании
Keywords: ISO TR 37137, absorbable implants, biological evaluation, ISO 10993, degradation products, leachables, biocompatibility, hemocompatibility, sterilization considerations, drug-device combination.