Norm

NEN-EN-ISO 16061:2009-1 en

Instrumenten die samen met niet-actieve chirurgische implantaten worden gebruikt - Algemene eisen (corrected and reprinted)

  • Deze norm is ingetrokken sinds 10-06-2015

106,87

Over deze norm

Status Ingetrokken
Aantal pagina's 19
Commissie Chirurgische implantaten
Gepubliceerd op 01-08-2009
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 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, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be 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 11.040.30
11.040.40
11.040.99
Nederlandse titel Instrumenten die samen met niet-actieve chirurgische implantaten worden gebruikt - Algemene eisen (corrected and reprinted)
Engelse titel Instrumentation for use in association with non-active surgical implants - General requirements (corrected and reprinted)
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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