Norm

NEN-EN-ISO 10993-7:2006 Ontw. en

Biologische evaluatie van medische hulpmiddelen - Deel 7: Ethyleenoxidesterilisatie-residuen

  • Deze norm is ingetrokken sinds 29-10-2008

51,12

Over deze norm

Status Ingetrokken
Aantal pagina's 86
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-02-2006
Taal Engels
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices; procedures for the measurement of EO and ECH; and methods for determining compliance so that devices may be released. Additional background and guidance and a flowchart showing how the standard is applied are also included in informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this standard.

Details

ICS-code 11.100.20
Nederlandse titel Biologische evaluatie van medische hulpmiddelen - Deel 7: Ethyleenoxidesterilisatie-residuen
Engelse titel Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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