DIN EN ISO 10650:2016-02

This document specifies requirements and test methods for powered polymerization activators in the 400 nm to 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 can 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. Where specified in the individual clauses of this International Standard, ISO 10605 takes precedence over IEC 60601-1: 2005 + A1: 2012. The requirements for the instructions for use and marking are also specified. This International Standard has been prepared by ISO/TC 106/SC 6/WG 7 "Powered polymerization activators" (secretariat: ANSI, USA) together with CEN/TC 55 "Dentistry" (secretariat: DIN). On the national level NA 014-00-01-04 AK "Lichtpolymerisationsgeräte" ("Powered polymerization activators") at Working Committee NA 014-00-01 AA "Füllungswerkstoffe" ("Filling materials") of NADENT is responsible. The standard is a summary of the existing two standards ISO 10650-1 and ISO 10650-2; as a result of the further development of lighting technology, new LED powered polymerization activators (according to ISO 10650-2) are being sold in Germany today. Existing old appliances (according to ISO 10650-1) in the dental surgery as well as powered polymerization activators sold in other countries require, however, that both techniques still shall be described in the summary of this standard.