60.60 Standard published Mar 28, 2018
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 | 11.100.20 Biological evaluation of medical devices
This CEN Workshop Agreement (CWA) provides a tiered approach for evaluating the biological impact in vitro, of wear particles generated in joint replacements and related medical devices, such as screws and trauma plates used in treating fractures. The approach is based on existing, well established test methods that have been widely employed to assess wear particle responses, including: a cell viability assay to assess cytotoxicity; enzyme linked immunosorbent assay (ELISA) to assess inflammatory cytokine release; an oxidative stress assay to assess release of reactive oxygen species (ROS); and a comet assay to assess damage to DNA.
This CWA does not cover the following:
a) the biological evaluation of the bulk materials from which medical devices are manufactured;
b) procedures for the isolation of wear particles from joint replacements and related medical devices, which are the subject of CWA 17253 1; and
c) safety issues associated with the execution of the assays covered by CWA 17253 2 or the health and well-being of recipients of joint replacements.
This CWA is for use by manufacturers of joint replacements evaluating new and existing materials and designs for human joint replacements and related devices, commercial, industrial and academic laboratories undertaking evaluation of, and studies into, device and material performance, and might be of use to other organizations, including regulators, concerned with the potential impact on the health and well-being of recipients of joint replacements.
Legislation related to this standard
60.60 Standard published
Mar 28, 2018