Norm

NEN-EN-ISO 14630:2006 Ontw. en

Niet-actieve chirurgische implantaten - Algemene eisen

  • Deze norm is ingetrokken sinds 29-01-2008

25,62

Over deze norm

Status Ingetrokken
Aantal pagina's 20
Commissie Chirurgische implantaten
Gepubliceerd op 01-09-2006
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 given or referred to in Level 2 and Level 3 Standards.

Details

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

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