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Standard

SN EN ISO 10993-4:2009

Ritirato

Nota: Ultima versione: SN EN ISO 10993-4:2018

Anteprima

Le modifiche e le versioni esistenti o nuove devono essere acquistate separatamente.

Lingua
Servizi

Astratto

ISO 10993-4:2002 provides general requirements for evaluating the interactions of medical devices with blood. It describes a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1, the fundamental principles governing the evaluation of the interaction of devices with blood, the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for interactions of devices with blood. ISO 10993-4:2002 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.

Specifiche dei prodotti

  • Standard da INB
  • Pubblicato:
  • Ritirato:
  • 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

Relazioni con i prodotti