Norm

NEN-EN-ISO 16061:2015 en

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

106,87

Over deze norm

Status Definitief
Aantal pagina's 19
Commissie Chirurgische implantaten
Gepubliceerd op 01-06-2015
Taal Engels
NEN-EN-ISO 16061 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves. With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer. This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.

Details

ICS-code 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
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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