This International Standard specifies requirements and test methods for operating lights used in the dental office and intended for illuminating the oral cavity of patients. It also contains specifications on manufacturers' instructions for use, marking and packaging. This International Standard applies to operating lights, irrespective of the technology of the light source. This International Standard excludes auxiliary light sources, e.g. from dental handpieces and dental headlamps and also operating lights which are specifically designed for use in oral surgery.
Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
4.1 According to type of protection against electric shock
4.2 According to mode of operation
5 Requirements and recommendations
5.1 General requirements
5.2 Optical requirements
5.3 Mechanical requirements
5.4 Cleaning and disinfection
5.5 Electrical requirements
5.6 Usability
6 Sampling
7 Testing
7.1 General
7.2 Visual inspection
7.3 Optical tests
7.4 Mechanical tests
7.5 Cleaning and disinfection
8 Manufacturer's instructions
8.1 Documents
8.2 General
8.3 Instructions for use
8.4 Technical description
8.5 Check
9 Packaging
10 Marking
10.1 Marking on the outside of mains-operated operating lights
10.2 Marking on the inside of operating lights
10.3 Graphical symbols
10.4 Colours of the insulation of conductors
10.5 Indicator lights and push-buttons
Annex A Transformation formulas (informative)
Annex B Normalized absorbance of camphorquinone (normative)
IEC 60050-845
IEC 60598-1
IEC 60601-1:2005 + A1:2012
IEC 62366
IEC 62471:2006
IEC 80601-2-60
ISO 14971 Medical devices — Application of risk management to medical devices
ISO 15223-1 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
ISO 1942 Dentistry — Vocabulary
ISO 21530 Dentistry — Materials used for dental equipment surfaces — Determination of resistance to chemical disinfectants
ISO 4073 Dentistry — Information system on the location of dental equipment in the working area of the oral health care provider
ISO 9687 Dentistry — Graphical symbols for dental equipment