Norm

ISO 11135:1994 en

Medical devices - Validation and routine control of ethylene oxide sterilization

  • Deze norm is ingetrokken sinds 23-07-2008

98,05

Over deze norm

Status Ingetrokken
Aantal pagina's 24
Gepubliceerd op 27-01-1994
Taal Engels
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.

Details

ICS-code 11.080.01
Nederlandse titel Medical devices - Validation and routine control of ethylene oxide sterilization
Engelse titel Medical devices - Validation and routine control of ethylene oxide sterilization
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