NEN-EN-ISO 14630:1997 en

Niet-actieve chirurgische implantaten - Algemene eisen

  • Deze norm is ingetrokken sinds 18-05-2005


Over deze norm

Status Ingetrokken
Aantal pagina's 17
Commissie Chirurgische implantaten
Gepubliceerd op 01-11-1997
Taal Engels
Specifies general requirements for non-active surgical implants. This standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intraocular lenses. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacture , sterilization, packaging and information supplied by the manufacturer, and tests. Tests required to be used to demonstrate compliance with this standard are contained in other levels.


ICS-code 11.040.40
Nederlandse titel Niet-actieve chirurgische implantaten - Algemene eisen
Engelse titel Non-active surgical implants - General requirements
Vervangen door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen



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