SIST EN ISO 28888:2014

Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues (ISO 28888:2013)

ISO 28888:2013 specifies a screening method for the erosion potential of non-fluoridated oral rinses on dental hard tissues. The results of the screening method are intended for use in enamel and/or dentine erosion models.

Zahnheilkunde - Screeningverfahren für das Erosionspotential von Mundwässern (ISO 28888:2013)

Diese Internationale Norm legt ein Screeningverfahren für das Erosionspotential von nicht fluoridhaltigen Mundwässern auf Zahnhartgewebe fest.
Die Ergebnisse des Screeningverfahrens sollen auf Schmelz- und/oder Dentinerosionsmodelle angewendet werden.

Médecine bucco-dentaire - Méthode de criblage de l'érosion potentielle des tissus durs dentaires due aux rinçages oraux (ISO 28888:2013)

L'ISO 28888:2013 spécifie une méthode de criblage du potentiel d'érosion des bains de bouche non fluorés sur les tissus durs dentaires. Les résultats de la méthode de criblage sont destinés à être utilisés dans des modèles d'érosion de l'émail et/ou de la dentine.

Zobozdravstvo - Presejalna metoda za morebitno erozijo zobnih trdih tkiv pri ustnih vodah za izpiranje (ISO 28888:2013)

General Information

• Status: Published
• Public Enquiry End Date: 19-Nov-2012
• Publication Date: 02-Jan-2014
• ICS: 11.060.01 - Dentistry in general
• ICS: 71.100.70 - Cosmetics. Toiletries
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 05-Dec-2013
• Due Date: 09-Feb-2014
• Completion Date: 03-Jan-2014
• Directive: 1223/2009 - Commission communication in the framework of the implementation of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 28888:2013 - Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues (ISO 28888:2013)

Overview

EN ISO 28888:2013 - “Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues” (ISO 28888:2013) is a CEN-endorsed laboratory screening standard for assessing the potential of non‑fluoridated oral rinses to cause dental erosion. The method provides a rapid, reproducible in vitro pH‑based screening procedure whose results feed into enamel and/or dentine erosion models. Products that exceed the screening threshold are referred to more complex erosion testing.

Key Topics and Requirements

• Scope: Screening test for erosion potential of non‑fluoridated oral rinses on enamel and dentine. Results are intended for use in erosion models.
• Pass/fail criterion: Maximum allowable mean pH decrease = 1.0 pH unit. A larger decrease means the rinse fails the screening and requires further testing (e.g., ISO 16408).
• Sampling: Two representative samples from each of three production batches (total six samples). Each sample is tested in four replicate runs.
• Test solution & volumes:
  • Prepare a calcium‑phosphate diluted screening solution from two 1 mol/L stock solutions (CaCl2·2H2O and KH2PO4).
  • Use 25 ml of the screening solution in a 50 ml reaction vessel and add 0.25 ml of test oral rinse or reference buffer.
• Operating conditions: Ambient temperature 18–27 °C, stirring above ~100 r/min, pH measured with a calibrated electrode (sensitivity ±0.05 pH units).
• Reference buffers and reagents: Three citrate buffer references (approximate pH 3.60, 3.68, 3.77) and specified reagent list (citric acid, trisodium citrate dihydrate, CaCl2, KH2PO4, sodium azide preservative, etc.).
• Data reporting: Record starting pH, test material pH, final pH, pH change per run; report mean and standard deviation for six samples.

Applications and Who Uses It

• Oral care manufacturers use ISO 28888 for early-stage formulation screening to avoid erosive oral rinse products.
• R&D and quality control laboratories apply the method for batch verification and stability testing of non‑fluoridated rinses.
• Regulatory bodies and conformity assessors reference the screening outcome when evaluating product safety claims related to dental hard tissue compatibility.
• Dental researchers use the standardized screening data as inputs for enamel/dentine erosion models and follow‑up in vitro or clinical studies.

Practical benefits include a standardized, reproducible pH‑based protocol that helps quickly identify potentially erosive formulations before committing to resource‑intensive, clinically relevant testing.

Related Standards

• ISO 16408 - referred to for more complex erosion testing when a product fails this screening.
• ISO 3696, ISO 78‑2, ISO 1942 - normative references for water quality, chemical analysis layout, and dental vocabulary used in this method.

Keywords: ISO 28888, EN ISO 28888, dental erosion screening, oral rinses, erosion potential, enamel erosion, dentine erosion, pH decrease, oral care testing, non‑fluoridated mouthwash.

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2014
Zobozdravstvo - Presejalna metoda za morebitno erozijo zobnih trdih tkiv pri
ustnih vodah za izpiranje (ISO 28888:2013)
Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues
(ISO 28888:2013)
Zahnheilkunde - Screeningverfahren für das Erosionspotential von Mundwässern (ISO
28888:2013)
Médecine bucco-dentaire - Méthode de criblage de l'érosion potentielle des tissus durs
dentaires due aux rinçages oraux (ISO 28888:2013)
Ta slovenski standard je istoveten z: EN ISO 28888:2013
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 28888
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2013
ICS 97.170
English Version
Dentistry - Screening method for erosion potential of oral rinses
on dental hard tissues (ISO 28888:2013)
Médecine bucco-dentaire - Méthode de criblage de Zahnheilkunde - Screeningverfahren für das
l'érosion potentielle des tissus durs dentaires due aux Erosionspotential von Mundwässern auf Zahnhartgewebe
rinçages oraux (ISO 28888:2013) (ISO 28888:2013)
This European Standard was approved by CEN on 31 August 2013.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 28888:2013: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 28888:2013) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in
collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by April 2014, and conflicting national standards shall be withdrawn at the
latest by April 2014.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 28888:2013 has been approved by CEN as EN ISO 28888:2013 without any modification.

INTERNATIONAL ISO
STANDARD 28888
First edition
2013-10-01
Dentistry — Screening method for
erosion potential of oral rinses on
dental hard tissues
Médecine bucco-dentaire — Méthode de criblage de l’érosion
potentielle des tissus durs dentaires due aux rinçages oraux
Reference number
ISO 28888:2013(E)
©
ISO 2013
ISO 28888:2013(E)
© ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2013 – All rights reserved

ISO 28888:2013(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test method . 1
4.1 General . 1
4.2 Maximum decrease in pH . 1
4.3 Reagents. 2
4.4 Apparatus . 2
4.5 Sampling . 3
4.6 Test method . 3
5 Test report . 4
Bibliography . 6
ISO 28888:2013(E)
Foreword
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bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
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electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
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different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
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on the ISO list of patent declarations received. www.iso.org/patents
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