Norm

NEN-ISO 17853:2011 en

Gebruik van materialen voor implantaten - Gebruiksdeeltjes van polymeren en metaal - Isolatie, karakterisering en kwantificering

79,70

Over deze norm

Status Definitief
Aantal pagina's 15
Commissie Chirurgische implantaten
Gepubliceerd op 01-03-2011
Taal Engels
This International Standard specifies methods for sampling wear particles generated by joint replacement implants in humans and in joint simulators. It specifies the apparatus, reagents and test methods to isolate and characterize both polymer and metal wear particles from samples of tissues excised from around the joint replacement implant, obtained at revision surgery or post mortem, and from samples of joint simulator test fluids. Some of these procedures could certainly be adapted for isolation and characterization of particles from human biological fluids (e.g. synovial fluid). The methods given in this International Standard do not quantify the level of wear the implant produces; neither do they determine the amount of wear from any particular surface. This International Standard does not cover the biological effects of wear particles or provide a method for evaluation of biological safety.

Details

ICS-code 11.040.40
Nederlandse titel Gebruik van materialen voor implantaten - Gebruiksdeeltjes van polymeren en metaal - Isolatie, karakterisering en kwantificering
Engelse titel Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
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