Norm

NEN-EN 12442-1:1998 2e 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 01-09-2000

23,50

Over deze norm

Status Ingetrokken
Aantal pagina's 20
Gepubliceerd op 01-04-1998
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). This part is intended to provide requirements and guidance on risk analysis related to the typical hazards of medical devices manufactured utilizing aninmal tissues or derivatives such as a) contamination by bacteria, moulds or yeasts; b) contamination by viruses or transmissible agents such as pathogenic entities, or agents causing spongiform encephalopathies prions and similar entities (e.g. BSE, scrapie); c) undesired pyrogenic, immunological or toxicological reactions.

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
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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