Norm

NEN-EN 12011:1998 en

Instrumenten die samen met niet-actieve chirurgische implantaten worden gebruikt - Algemene eisen

  • Deze norm is ingetrokken sinds 12-01-2009

61,30

Over deze norm

Status Ingetrokken
Aantal pagina's 24
Commissie Chirurgische implantaten
Gepubliceerd op 01-02-1998
Taal Engels
Specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements applies to instruments when they are manufactured and when they are resupplied after refurbishment. This standard applies to instruments which may be connected to powered driven systems, but does not apply to the powered driven system itself. This standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants. Gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer.

Details

ICS-code 11.040.30
Nederlandse titel Instrumenten die samen met niet-actieve chirurgische implantaten worden gebruikt - Algemene eisen
Engelse titel Instrumentation to be used in association with non-active surgical implants - General requirements
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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