ISO 9680:2021
Dentistry — Operating lights
This document 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 the instructions for use, marking and packaging.
This document applies to operating lights, irrespective of the technology of the light source.
This document excludes auxiliary light sources, for example, from dental handpieces and dental headlamps and also operating lights which are specifically designed for use in oral surgery.
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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
5.2.1 Adjustable level of illuminance
5.2.2 Illumination pattern
5.2.3 Illuminance in patient's eyes
5.2.4 Chromatic uniformity
5.2.5 Correlated colour temperature
5.2.6 Shadow
5.2.7 Colour fidelity
5.2.8 Actinic UV hazard exposure for the skin and eye
5.2.9 Near-UV hazard exposure for the eye
5.2.10 Retinal blue light hazard exposure
5.2.11 Single fault condition for photobiological safety
5.2.12 Heat due to optical radiation
5.2.13 Compatibility with light-activated restorative materials
5.3 Mechanical requirements
5.3.1 Moving parts
5.3.2 Operating controls
5.3.3 Rotary movement
5.3.4 Handling and mechanical adjustment
5.3.5 Expelled parts
5.4 Reprocessing
5.5 Electrical requirements
5.6 Usability
6 Sampling
7 Testing
7.1 General
7.2 Visual inspection
7.3 Optical tests
7.3.1 Test set-up
7.3.2 Level of illuminance and illuminance pattern
7.3.3 Illuminance uniformity
7.3.4 Illuminance in the patient’s eyes
7.3.5 Chromatic uniformity
7.3.6 Correlated colour temperature
7.3.7 Shadow
7.3.8 Colour fidelity
7.3.9 Actinic UV hazard exposure for the skin and eye
7.3.10 Near-UV hazard exposure for the eye
7.3.11 Retinal blue light hazard exposure
7.3.12 Heat due to optical radiation
7.3.13 Compatibility with light-activated restorative materials
7.4 Mechanical tests
7.4.1 Moving parts
7.4.2 Stability after positioning
7.4.3 Operating force
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 (informative) Transformation formulae
Annex B (normative) Normalized absorbance of camphorquinone
Bibliography
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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
5.2.1 Adjustable level of illuminance
5.2.2 Illumination pattern
5.2.3 Illuminance in patient's eyes
5.2.4 Chromatic uniformity
5.2.5 Correlated colour temperature
5.2.6 Shadow
5.2.7 Colour fidelity
5.2.8 Actinic UV hazard exposure for the skin and eye
5.2.9 Near-UV hazard exposure for the eye
5.2.10 Retinal blue light hazard exposure
5.2.11 Single fault condition for photobiological safety
5.2.12 Heat due to optical radiation
5.2.13 Compatibility with light-activated restorative materials
5.3 Mechanical requirements
5.3.1 Moving parts
5.3.2 Operating controls
5.3.3 Rotary movement
5.3.4 Handling and mechanical adjustment
5.3.5 Expelled parts
5.4 Reprocessing
5.5 Electrical requirements
5.6 Usability
6 Sampling
7 Testing
7.1 General
7.2 Visual inspection
7.3 Optical tests
7.3.1 Test set-up
7.3.2 Level of illuminance and illuminance pattern
7.3.3 Illuminance uniformity
7.3.4 Illuminance in the patient’s eyes
7.3.5 Chromatic uniformity
7.3.6 Correlated colour temperature
7.3.7 Shadow
7.3.8 Colour fidelity
7.3.9 Actinic UV hazard exposure for the skin and eye
7.3.10 Near-UV hazard exposure for the eye
7.3.11 Retinal blue light hazard exposure
7.3.12 Heat due to optical radiation
7.3.13 Compatibility with light-activated restorative materials
7.4 Mechanical tests
7.4.1 Moving parts
7.4.2 Stability after positioning
7.4.3 Operating force
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 (informative) Transformation formulae
Annex B (normative) Normalized absorbance of camphorquinone
Bibliography