Standard Svensk standard · SS-EN ISO 10993-9:2009

Biologisk värdering av medicintekniska produkter - Del 9: Ram för identifiering och kvantifiering av potentiella nedbrytningsprodukter (ISO 10993-9:2009)

Status: Gällande

Köp denna standard

Standard Svensk standard · SS-EN 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 standarden - Läs mer Dölj
Pris: 755 SEK
standard ikon pdf

PDF

Pris: 755 SEK
standard ikon

Papper

Pris: 1 208 SEK
standard ikon pdf + standard ikon

PDF + papper

Fler alternativ Färre alternativ
Omfattning
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.

Ämnesområden

Biologisk värdering av medicintekniska produkter (11.100.20)


Köp denna standard

Standard Svensk standard · SS-EN 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 standarden - Läs mer Dölj
Pris: 755 SEK
standard ikon pdf

PDF

Pris: 755 SEK
standard ikon

Papper

Pris: 1 208 SEK
standard ikon pdf + standard ikon

PDF + papper

Fler alternativ Färre alternativ

Produktinformation

Språk: Engelska

Framtagen av: Biologisk säkerhet, SIS/TK 340/AG 02

Internationell titel:

Artikelnummer: STD-72079

Utgåva: 3

Fastställd: 2009-12-21

Antal sidor: 24

Ersätter: SS-EN ISO 10993-9:2009