Norm

CWA 17253-1:2018 en

Gewrichtsimplantaten - Deel 1: Nieuwe methoden voor het isoleren van slijtagedeeltjes bij gewrichtsprothesen en verwante hulpmiddelen

52,00 62,92 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 21
Commissie Chirurgische implantaten
Gepubliceerd op 01-03-2018
Taal Engels
CWA 17253-1 describes test methods for the isolation and characterization of wear particles generated by joint replacement implants and related devices in animals, humans and in joint simulators. It specifies the apparatus, reagents and methodologies to isolate polyethylene, metallic, ceramic and ceramic-like coating wear particles from both fixed and unfixed tissue samples that are harvested from the periprosthetic site, obtained at revision or post mortem, and from samples of joint simulator test fluids. CWA 17253-1 complements the existing test methods for isolating wear particles of conventional ultra-high molecular weight polyethylene (UHMWPE) from tissues and test fluids from joint simulators, as described in ISO 17853:2011. The methods described in CWA 17253-1 do not allow quantification of the volume of wear an implant generates; neither do they determine the amount of wear from any particular interface or surface. CWA 17253-1 does not address the biological impact of wear particles released from joint replacements, which is the topic of CWA 17253-2. CWA 17253-1 is for use by researchers in the orthopaedic field, implant manufacturers and regulators, with an interest in the wear of implants and analysis of wear particles with the aim of enhancing understanding of implant performance.

Details

ICS-code 11.040.40
Nederlandse titel Gewrichtsimplantaten - Deel 1: Nieuwe methoden voor het isoleren van slijtagedeeltjes bij gewrichtsprothesen en verwante hulpmiddelen
Engelse titel Joint implants - Part 1: Novel methods for isolating wear particles from joint replacements and related devices

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