Name: EN ISO 10650:2015
Brand: CEN

EN ISO 10650:2015

Superseded

View Superseded by

Dentistry - Powered polymerization activators (ISO 10650:2015)

Superseded date

02-02-2019

Published date

09-30-2015

Publisher

Comite Europeen de Normalisation

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
6 Sampling
7 Test methods
8 Information to be supplied by the manufacturer
9 Marking
10 Packaging
Bibliography

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 60601‑1 where specified in the individual clauses of this International Standard.

Committee	CEN/TC 55
DevelopmentNote	Supersedes EN ISO 10650-1 & EN ISO 10650-2. (10/2015)
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN ISO 10650:2018
Supersedes	EN ISO 10650-2:2007 EN ISO 10650-1:2005

Standards	Relationship
NEN EN ISO 10650:2018	Identical
SN EN ISO 10650 : 2016	Identical
I.S. EN ISO 10650:2015	Identical
BS EN ISO 10650:2018	Identical
DIN EN ISO 10650 E : 2016	Identical
BS EN ISO 10650:2015	Identical
NS-EN ISO 10650 : 2018	Identical
ONORM EN ISO 10650 : 2016	Identical
NEN EN ISO 10650 : 2015	Identical
PN EN ISO 10650 : 2016	Identical
UNE-EN ISO 10650:2016	Identical
ISO 10650:2015	Identical
UNI EN ISO 10650 : 2015	Identical
ÖNORM EN ISO 10650: 2018	Identical
NS EN ISO 10650 : 2015	Identical
DIN EN ISO 10650:2016-02	Identical
ISO 10650:2018	Identical
I.S. EN ISO 10650:2018	Identical
DIN EN ISO 10650:2018-12	Identical
PN-EN ISO 10650:2018	Identical

IEC 60601-2-57:2011	Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
IEC 80601-2-60:2012	Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ISO 1942:2009	Dentistry Vocabulary
IEC 62471:2006	Photobiological safety of lamps and lamp systems
ISO 9687:2015	Dentistry Graphical symbols for dental equipment
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements