ISO 10650:2015 specifies requirements and test methods for powered polymerization activators in the 385 nm - 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials. This International Standard 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 International Standard. ISO 10650:2015 does not cover powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures, or other oral dental appliances. This International Standard takes priority over IEC 60601 where specified in the individual clauses of this International Standard.
Rationale
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.