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EN ISO 10650:2015

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Dentistry - Powered polymerization activators (ISO 10650:2015)

Superseded date

02-02-2019

Superseded by

EN ISO 10650:2018

Published date

30-09-2015

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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Superseded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
Supersedes

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

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