What is BS EN 1642 - Dental implants about?
BS EN 1642 is a European standard that discusses medical devices for dentistry. BS EN 1642 layouts general requirements for dental implants and accessories to ensure the acceptable quality standards for dental implants.
BS EN 1642 includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
Note: Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641.
Who is BS EN 1642 - Dental implants for?
BS EN 1642 on dental implants is useful for:
- Manufacturers of dental implants
- Medical laboratories for dentistry
- Regulatory authorities
Why should you use BS EN 1642 - Dental implants?
A dental implant is a device designed to be placed surgically within or on the mandibular or maxillary bone to provide resistance to displacement of a dental prosthesis or to provide orthodontic anchorage.
BS EN 1642 guideline assists you with requirements on design, properties, materials, contents of technical file, biocompatibility, biophysical properties, modelling, control of contamination, dental implants supplied sterile, dental implants supplied non-sterile, dental implants which incorporate materials of animal origin, dental implants used in combination, clinical investigation, and evaluation for dental implants for dentistry.
BS EN 1642 also guides on marking, labelling, the information supplied by the manufacturer, and instructions for use for dental implants.
With obedience and compliance to BS EN 1642, you can standardise the acceptable quality of dental products and prolongs the life of dental implants. In addition, ensure the health and safety of users of dental implants.
What’s changed since the last update?
BS EN 1642:2011 supersedes EN 1642:2009, which has been withdrawn. BS EN 1642:2011 has made some technical changes compared to EN 1642:2009. These include:
- Addition of new relevant product standards, issued after 2004 and deletion of the following withdrawn standards: EN 550, EN 552, EN ISO 14727.
- 5 clinical evaluation: clarification of the requirement for a clinical evaluation
- 6.4 instructions for use: clarification of the requirement that information may be provided in an electronic format
- Annex ZA: actualisation of the annex