Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants.

Objeto y campo de aplicación

The objective of this Technical Report 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.

Información general

Código del comité
CTN N.A 
Nombre del comité
N.A 
Sector
Salud 
ICS
11.040.10  
Correspondencias
ISO TR 37137:2014  
Organismos
ISO  
Edición
Fecha de aprobación
2020-06-30 
Número de páginas
23 
Estado
Vigente