Norm

NEN-EN-ISO 16061:2007 Ontw. en

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

  • Deze norm is ingetrokken sinds 26-01-2009

31,83

Over deze norm

Status Ingetrokken
Aantal pagina's 25
Commissie Chirurgische implantaten
Gepubliceerd op 01-10-2007
Taal Engels
This International Standard specifies general requirements for instruments to be used in association with nonactive surgical implants. These requirements apply to instruments when they a re manufactured and when they are resupplied after refurbishme nt. This International Standard also applies to instruments wh ich may be connected to power-driven systems, but does not app ly to the power-driven systems themselves. With regard to safe ty this International Standard gives requirements for intended performance, design attributes, selection of materials, desig n evaluation, manufacture, sterilization, packaging and inform ation to be supplied by the manufacturer.

Details

ICS-code 11.040.30
11.040.40
11.040.99
Nederlandse titel Instrumenten die samen met niet-actieve chirurgische implantaten worden gebruikt - Algemene eisen
Engelse titel Instrumentation for use in association with non-active surgical implants - General requirements
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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