This document specifies requirements and test methods for powered polymerization activators in the 380 nm to 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials. This document applies to quartz-tungsten-halogen lamps and light-emitting diode (LED) lamps. Powered polymerization activators could have internal power supply (rechargeable battery powered) or be connected to external (mains) power supply. Lasers or plasma arc devices are not covered by this standard. This document does not cover powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances.
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Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
5.1 General
5.2 Radiant exitance
5.3 Electrical safety requirements
5.4 Physical and mechanical safety
5.5 Usability
5.6 Instructions for use manual
5.7 Technical Description
5.8 Marking
5.9 Packaging
6 Sampling
7 Measurement and test methods
7.1 General
7.2 Inspections
7.3 Measurement of the optical cross-sectional area of the light guide/light-emitting tip
7.4 Measurement of radiant exitance
8 Information (instructions for use) to be supplied by the manufacturer
IEC 60601-1 AMD 1:2012
IEC 60601-1-2:2014
IEC 60601-1:2005
IEC 62366-1:2015
IEC 80601-2-60:2012
ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
ISO 17664:2017 Processing of health care products -- Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 1942:2009 Dentistry -- Vocabulary
ISO 9687:2015 Dentistry -- Graphical symbols for dental equipment