Norm

NEN-EN-ISO 21534:2006 Ontw. en

Niet-actieve chirurgische implantaten - Gewrichtsimplantaten - Bijzondere eisen

  • Deze norm is ingetrokken sinds 08-10-2007

25,62

Over deze norm

Status Ingetrokken
Aantal pagina's 19
Commissie Chirurgische implantaten
Gepubliceerd op 01-01-2006
Taal Engels
This International Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this standard, artificial ligaments and their associated fixing devices are included in the term implant, hereinafter referred to as implants. It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer. Some tests required to demonstrate conformance to this standard are contained in or referenced in level 3 standards.

Details

ICS-code 11.040.40
Nederlandse titel Niet-actieve chirurgische implantaten - Gewrichtsimplantaten - Bijzondere eisen
Engelse titel Non-active surgical implants - Joint replacement implants - Particular requirements
Vervangt
Vervangen door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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