BS EN 1642:2009 Dentistry. Medical devices for dentistry. Dental implants
There are three levels of standards dealing with medical devices used in dentistry.
These are as follows:
- Level 1: General requirements for medical devices
- Level 2: Requirements for families of medical devices used in dentistry
- Level 3: Specific requirements for types of medical devices used in dentistry
There are no level 1 standards written exclusively in respect of medical devices used in dentistry.
BS EN 1642 is a level 2 standard and details requirements that apply to dental implants (for surgically implantable dental materials included within the definition of restorative materials see BS EN 1641). It is also indicated that there are additional requirements in the level 3 standards. Where available, these are included as normative references. To cover all the requirements for a particular product, it is necessary to use a standard of the lowest available level.
BS EN 1642 is the British Standard that specifies the general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641.
BS EN 1642 includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
BS EN 1642 now includes an informative annex to explain the relationship between the standard and the Essential Requirements of EU Directive 93/42/EEC.
Contents of BS EN1642 include:- Scope
- Normative references
- Terms and definitions
- Requirements
- Design and properties
- Materials
- Contents of technical file
- Biocompatibility
- Biophysical properties and 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
- Marking, labelling and information supplied by the manufacturer
- Symbols
- Label
- Instructions for use
- Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC
- Bibliography
BS EN 1642:2009 replaces BS EN 1642:2004 which has been withdrawn
