Norm

NPR-ISO/TR 37137:2014 en

Beoordeling van cardiovasculaire biologische medische apparatuur - Richtlijn voor resorbeerbare implantaten

79,70

Over deze norm

Status Definitief
Aantal pagina's 17
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-07-2014
Taal Engels
NPR-ISO/TR 37137 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.

Details

ICS-code 11.040.40
Nederlandse titel Beoordeling van cardiovasculaire biologische medische apparatuur - Richtlijn voor resorbeerbare implantaten
Engelse titel Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants

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