NEN-EN-ISO 14630:2005 en

Niet-actieve chirurgische implantaten - Algemene eisen

  • Deze norm is ingetrokken sinds 29-01-2008


Over deze norm

Status Ingetrokken
Aantal pagina's 13
Commissie Chirurgische implantaten
Gepubliceerd op 01-05-2005
Taal Engels
This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses. With regard to safety, this standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests required to demonstrate compliance with these requirements. Additional tests are contained or referred to 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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