Biologisk värdering av medicintekniska produkter - Del 9: Ram för identifiering och kvantifiering av potentiella nedbrytningsprodukter (ISO 10993-9:2009)
Biologisk värdering av medicintekniska produkter - Del 9: Ram för identifiering och kvantifiering av potentiella nedbrytningsprodukter (ISO 10993-9:2009)
Prenumerera på standarder med tjänst SIS Abonnemang. Genom att prenumerera får du effektiv åtkomst till gällande standarder och säkerställer att ditt företag alltid har tillgång till senaste utgåvan.
Läs mer om SIS Abonnemang
This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This part of ISO 10993 considers both non-resorbable and resorbable materials. This part of ISO 10993 is not applicable to: a) evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available; NOTE 1 Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this part of ISO 10993, such degradation products can evoke a biological response and thus need to undergo biological evaluation as described in other parts of ISO 10993. b) leachable components which are not degradation products; c) medical devices or components that do not contact the patient's body directly or indirectly. NOTE 2 This part of ISO 10993 can be applied to the degradation of materials used in any kind of product that falls within the definition of “medical device” in ISO 10993-1, even if such products are subject to different regulations from those applying to medical devices, e.g. the scaffold in a tissue engineered medical product, or a carrier matrix to deliver drugs or biologics.
Biologisk värdering av medicintekniska produkter - Del 9: Ram för identifiering och kvantifiering av potentiella nedbrytningsprodukter (ISO 10993-9:2009)
Prenumerera på standarder med tjänst SIS Abonnemang. Genom att prenumerera får du effektiv åtkomst till gällande standarder och säkerställer att ditt företag alltid har tillgång till senaste utgåvan.
Läs mer om SIS Abonnemang
Internationell titel: Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)