Norm

NEN-EN 12442-1:1996 Ontw. en

Dierlijk weefsel en afgeleiden daarvan die voor de vervaardiging van medische producten worden gebruikt - Deel 1: Risicoanalyse en risicobeheer

  • Deze norm is ingetrokken sinds 01-04-1998

23,50

Over deze norm

Status Ingetrokken
Aantal pagina's 14
Gepubliceerd op 01-08-1996
Taal Engels
Applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, non-viable or rendered non-viable. It specifies, in conjunction with EN 1441, a procedure to investigate, using available information, the safety of such devices by identifying hazards and estimating the risks associated with the device (risk analysis). It is of particular assistance in areas where appropriate harmonized standards are not available or not used. This part of the standard does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot by their nature be set down in such a standard. The broad principles of this standard are deemed to apply to any viruses and transmissible agents.

Details

ICS-code 11.120.20
Nederlandse titel Dierlijk weefsel en afgeleiden daarvan die voor de vervaardiging van medische producten worden gebruikt - Deel 1: Risicoanalyse en risicobeheer
Engelse titel Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk
Vervangen door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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