Numéro de référence
ISO 11135:1994
ISO 11135:1994
Dispositifs médicaux — Validation et contrôle de routine de la stérilisation à l'oxyde d'éthylène
Edition 1
1994-01
Annulée
ISO 11135:1994
19154
Annulée (Edition 1, 1994)

Résumé

Establishes requirements and guidance. Particular attention is drawn to the need for specific testing for safety, quality and efficacy, possibly exceeding the general requirements, which may be necessary for a specific product. Attention is drawn to the existence in some countries of regulations laying down safety requirements for handling ethylene oxide and for premises in which it is used as well as of regulations laying down limits for the level of ethylene oxide residues within medical devices and products.

Informations générales

  •  : Annulée
     : 1994-01
    : Annulation de la Norme internationale [95.99]
  •  : 1
     : 26
  • ISO/TC 198
    11.080.01 
  • RSS mises à jour

Vous avez une question?

Consulter notre Aide et assistance