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  • BSI
    PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
    Edition: 2014
    $435.35
    / user per year

Description of PD ISO/TR 37137:2014 2014

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.



Standard NumberPD ISO/TR 37137:2014
TitleCardiovascular biological evaluation of medical devices. Guidance for absorbable implants
StatusRevision Underway
Publication Date2014-06-30
Identical National Standard OfISO/TR 37137:2014
DescriptorsClinical testing, Control samples, Cytotoxicity tests, Visual inspection (testing), Culture techniques, Classification systems, Testing conditions, Biological analysis and testing, Biological hazards, Laboratory animals, Toxicity, Specimen preparation, Tissue implantation tests
ICS11.040.40 Implants for surgery, prosthetics and orthotics
CommitteeCH/194
ISBN978 0 580 84352 5
PublisherBSI
Pages26

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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