Norm

NEN-EN-ISO 21534:2009 en

Niet-actieve chirurgische implantaten - Gewrichtsimplantaten - Bijzondere eisen

79,70

Over deze norm

Status Definitief
Aantal pagina's 13
Commissie Chirurgische implantaten
Gepubliceerd op 01-05-2009
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 International Standard, artificial ligaments and their associated fixing devices are included in the term "implant". 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 International 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
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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