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

    Object and field of application

    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.

    General information

    Committee Code
    EN 
    Committee Name
    Endoso 
    Sector
    Salud 
    ICS
    11.040.10  
    Correspondences
    ISO TR 37137:2014  
    Organism
    ISO  
    Edition
    Approval Date
    2020-06-30 
    Number of Pages
    23 
    State
    Vigente 

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