CWA 17253-1:2018

Joint implants - Part 1: Novel methods for isolating wear particles from joint replacements and related devices

General information

60.60 Standard published   Mar 28, 2018

CEN

CEN/WS 087 Novel methods for isolating wear particles from joint replacements and related devices and for evaluating their biological impact in vitro

CEN/CENELEC Workshop Agreement

11.040.40   Implants for surgery, prosthetics and orthotics

Scope

This CEN Workshop Agreement (CWA) 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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

NOW

PUBLISHED
CWA 17253-1:2018
60.60 Standard published
Mar 28, 2018