Implants for surgery, prosthetics and orthotics

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:

  • Active Implantable Medical Devices (AIMDD) Council Directive 90/385/EEC (1990)
  • Medical Devices Directive (MDD) Council Directive 93/42/EEC (1992)
  • In Vitro Diagnostic Directive (IVDD) Council Directive 98/79/EC (1998).

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.

BS EN ISO 25539-2:2009
Cardiovascular implants. Endovascular devices. Vascular stents

BS ISO 23317:2007
Implants for surgery. In vitro evaluation for apatite-forming ability of implant materials

BS ISO 13779-1:2008
Implants for surgery. Hydroxyapatite. Ceramic hydroxyapatite

BS ISO 13779-2:2008
Implants for surgery. Hydroxyapatite. Coatings of hydroxyapatite

BS ISO 13779-3:2008
Implants for surgery. Hydroxyapatite. Chemical analysis and characterization of crystallinity and phase purity

BS ISO 5832-1:2007
Implants for surgery. Metallic materials. Wrought stainless steel

BS ISO 29781:2008
Prostheses and orthoses. Factors to be included when describing physical activity of a person who has had a lower limb

BS ISO 29782:2008
Prostheses and orthoses. Factors to be considered when specifying a prosthesis for a person who has had a lower limb

BS ISO 29783-1:2008
Prosthetics and orthotics. Vocabulary. Normal gait

BS ISO 7206-1:2008
Implants for surgery. Partial and total hip joint prostheses. Classification and designation of dimensions
 
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