Norm

NEN-EN 12006-2:1995 Ontw. en

Niet-actieve chirurgische implantaten - Bijzondere eisen voor hart- en vaatimplantaten - Deel 2: Vaatprothesen en patches

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Over deze norm

Status Ingetrokken
Aantal pagina's 47
Commissie Chirurgische implantaten
Gepubliceerd op 01-08-1995
Taal Engels
Specifies particular requirements for vascular protheses and cardiovascular patches of synthetic or biological origin intended to replace, reconstruct, bypass of to form shunts between segments of the cardio-vascular system in humans. With regard to safety, in addition to the prEN 14630, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing and inspection, packaging, and information supplied by the manufacturer. This standard specifies the designation of materials of manufacture and the construction, and specifies the designation of sizes and dimensions of vascular protheses and cardiovascular patches. It refers to biological requirements of the materials of construction and of the finished product taking into account the appropriate parts of EN 30993. This standard also specifies the designation of mechanical properties. It describes methods for the measurement and verification of the dimensions and mechanical properties declared by the manufacturer, including durability testing. It refers to sterilization of protheses and specifies requirements for packaging and for information supplied by the manufacturer. It also provides definitions of the terms in common use.

Details

ICS-code 11.040.40
Nederlandse titel Niet-actieve chirurgische implantaten - Bijzondere eisen voor hart- en vaatimplantaten - Deel 2: Vaatprothesen en patches
Engelse titel Non-active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular protheses and cardio vascular patches
Vervangen door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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