If you design, develop, produce, install or service any medical device you need to comply with the requirements set out in the relevant European Directives:
BSI can help with best practice guidelines and supporting documentation relating to implants. Our standards specify requirements for:
- non-active surgical implants
- implants for surgery (including cardiac pacemakers and hip joint prostheses)
- prosthetics and orthotics.
In addition, BS 8432:2005 gives guidance on the design of spinal orthoses.
This part of ISO 5834 specifies the requirements and corresponding test methods for moulding materials in powder form made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants. It is not applicable to finished products.
