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Standard

SN EN ISO 10993-13:2010

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Astratto

ISO 10993-13:2010 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. ISO 10993-13:2010 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment. For materials that are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer. ISO 10993-13:2010 considers only non-resorbable polymers. Similar, but appropriately modified procedures may be applicable for resorbable polymers. ISO 10993-13:2010 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteins and cellular activity.

Specifiche dei prodotti

  • Standard da INB
  • Pubblicato:
  • Efficace:
  • Tipo di documento: EN
  • Pagine
  • ICS 11.100.20
  • Publisher SNV
  • Distributor SNV
  • National Committee INB/NK 129

Riferimento legale

Autorità federale svizzera: SWISSMEDIC
Designato ai sensi della legge svizzera:
Riferimento legaleRestrizioni
812.213
Designato ai sensi della legislazione dell'UE:
Riferimento legaleRestrizioni
90/385/EWG
Council Directive 93/42/EEC

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