Norm

NEN-EN-ISO 14630:2012 en

Niet-actieve chirurgische implantaten - Algemene eisen

79,70

Over deze norm

Status Definitief
Aantal pagina's 13
Commissie Chirurgische implantaten
Gepubliceerd op 01-12-2012
Taal Engels
This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests 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
Vervangt
Wijzigt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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