EN ISO 28399:2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Dentistry - Products for external tooth bleaching (ISO 28399:2011)
08-04-2020
15-01-2011
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
6 Test methods
7 Packaging, marking and information to be supplied
by the manufacturer
Annex A (informative) - Test method for the measurement
of hydrogen peroxide concentration
Annex B (informative) - Test method for the measurement
of erosion of enamel and dentine caused by products
for external tooth bleaching
Annex C (informative) - Test method for laboratory
assessment of tooth bleaching efficacy
Bibliography
ISO 28399:2011 specifies requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products). It also specifies requirements for their packaging, labelling and instructions for use.The following tooth bleaching products are not covered by ISO 28399:2011: those intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns; auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products.
Committee |
CEN/TC 55
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Superseded
|
SupersededBy |
Standards | Relationship |
ONORM EN ISO 28399 : 2011 | Identical |
ISO 28399:2011 | Identical |
NF EN ISO 28399 : 2011 | Identical |
NBN EN ISO 28399 : 2011 | Identical |
NS EN ISO 28399 : 2011 | Identical |
I.S. EN ISO 28399:2011 | Identical |
PN EN ISO 28399 : 2011 | Identical |
SN EN ISO 28399 : 2011 | Identical |
UNI EN ISO 28399 : 2011 | Identical |
UNE-EN ISO 28399:2011 | Identical |
BS EN ISO 28399:2011 | Identical |
DIN EN ISO 28399:2011-05 | Identical |
NEN EN ISO 28399 : 2011 | Identical |
ISO 11609:2017 | Dentistry — Dentifrices — Requirements, test methods and marking |
ISO 7405:2008 | Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
ISO 1942:2009 | Dentistry Vocabulary |
ISO 22727:2007 | Graphical symbols — Creation and design of public information symbols — Requirements |
ADA 41 : 2015 | EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
ISO 6344-1:1998 | Coated abrasives Grain size analysis Part 1: Grain size distribution test |
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