Norm

NEN-EN 12442-2:1996 Ontw. en

Dierlijk weefsel en afgeleiden daarvan die voor de vervaardiging van medische producten worden gebruikt - Deel 2: Bron, controle, verzameling en bewerking

  • Deze norm is ingetrokken sinds 01-04-1998

23,50

Over deze norm

Status Ingetrokken
Aantal pagina's 17
Gepubliceerd op 01-08-1996
Taal Engels
Specifies requirements for the sourcing, collection and handling of tissues for the manufacture of medical devices utilizing materials of animal origin other then in vitro diagnostic medical devices. It is applicable to materials of animal origin which are supplied to the manufacture for incorporation into medical devices. In this part of the standard the specific requirements and guidance take into account a diverse range of materials of animal origin. The controls are intended to minimize the risk arising from the use of unsuitable (contaminated or diseased) animal materials. This part of the standard does not cover the utilization of human tissues in medical devices. This part of the standard does not describe a quality assurance system for the control of all stages of manufacture.

Details

ICS-code 11.120.20
Nederlandse titel Dierlijk weefsel en afgeleiden daarvan die voor de vervaardiging van medische producten worden gebruikt - Deel 2: Bron, controle, verzameling en bewerking
Engelse titel Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Sourcing, controls, collection and handling
Vervangen door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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