BS EN 1640:2009 Dentistry. Medical devices for dentistry. Equipment
BS EN 1640 specifies general requirements for dental equipment used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, packaging, marking, labelling, and information supplied by the manufacturer.
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 1640 is a level 2 standard and details requirements that apply to those items of dental equipment which are medical devices. For energy sources connecting to dental instruments, BS EN 1640 should be used in conjunction with the standard applicable to dental instruments , BS EN 1639.
BS EN 1640 also indicates 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.
In the Bibliography a reference for guidance on the classification of dental devices and accessories [3] is given.
Contents of BS EN 1640 contain:- Scope
- Normative references
- Terms and definitions
- Requirements
- Chemical and physical properties
- Materials
- Contaminants and residues
- Contact with substances
- Ingress and leaking of substances􀀃
- Control of contamination
- Construction and environmental properties
- Protection against radiation
- Equipment connected to or equipped with an energy source
- Programmable electronic subsystems (software programmes)
- Protection against electrical risks
- Protection against mechanical and thermal risks
- Mechanical stability
- Vibration
- Noise
- Electricity, gas, hydraulic and pneumatic energy
- Surface temperature
- Controls and indicators
- Clinical evaluation Marking, labelling and information supplied by the manufacturer
- Symbols
- Marking
- Label
- Detachable components
- Instructions for use
- Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC
- Bibliography
BS EN 1640 does not apply to dental X-ray equipment, or to any dental instruments connected to an item of dental equipment. These instruments are covered by BS EN 1639.
Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.
