Dentistry - Integrated dental floss and handles (ISO 28158:2018)

This document specifies the requirements and test methods for integrated dental floss and handles used for home care, community care, professional care of oral health or a part of dental treatment.
This document is applicable to integrated dental floss and handles for manual use. It does not include dental floss and handles which contain a continuous supply of dental floss, or handles to which the floss is subsequently added.
This document excludes specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological risks. For assessment of such biological risks, see ISO 10993-1 and ISO 7405.

Zahnheilkunde - Zahnseide im Halter (ISO 28158:2018)

Médecine bucco-dentaire - Porte-fil et fil dentaire intégré (ISO 28158:2018)

Le présent document spécifie les exigences et les méthodes d'essai concernant les porte-fils et fils dentaires intégrés qui sont utilisés pour un usage personnel à domicile, au sein de centres de soins de santé bucco-dentaire, pour un usage professionnel ou dans le cadre d'un traitement dentaire.
Le présent document s'applique aux porte-fils et fils dentaires intégrés destinés à une utilisation manuelle. Il ne traite pas des porte-fils et fils dentaires qui comportent une alimentation continue en fil dentaire, ni des porte-fils auxquels le fil est ajouté par la suite.
Le présent document exclut les méthodes d'essai qualitatives ou quantitatives spécifiques visant à démontrer l'absence de risques biologiques inacceptables. Pour l'évaluation de tels risques biologiques, voir l'ISO 10993‑1 et l'ISO 7405.

Zobozdravstvo - Držala z vpeto zobno nitko (ISO 28158:2018)

Ta dokument določa zahteve in preskusne metode za držala z vpeto zobno nitko, ki se uporabljajo za domačo nego, nego v skupnosti, strokovno nego ustnega zdravja ali kot del zobozdravstvene nege. Ta dokument se uporablja za vpeto zobno nitko in ročaje za ročno uporabo. Ne zajema zobnih nitk in ročajev, ki vsebujejo neprekinjeno zalogo zobne nitke, ali ročaje, na katere se nitka vpne naknadno.
Ta dokument izključuje posebne kakovostne in količinske preskusne metode za prikaz odsotnosti nesprejemljivih bioloških tveganj. Za oceno takšnih bioloških tveganj glej ISO 10993-1 in ISO 7405.

General Information

Status
Withdrawn
Publication Date
30-Jan-2019
Withdrawal Date
29-Apr-2019
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
24-Oct-2018
Completion Date
24-Oct-2018

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SLOVENSKI STANDARD
SIST EN ISO 28158:2018
01-december-2018
1DGRPHãþD
SIST EN ISO 28158:2010
Zobozdravstvo - Držala z vpeto zobno nitko (ISO 28158:2018)
Dentistry - Integrated dental floss and handles (ISO 28158:2018)
Zahnheilkunde - Zahnseide im Halter (ISO 28158:2018)
Médecine bucco-dentaire - Porte-fil et fil dentaire intégré (ISO 28158:2018)
Ta slovenski standard je istoveten z: EN ISO 28158:2018
ICS:
97.170 Oprema za nego telesa Body care equipment
SIST EN ISO 28158:2018 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 28158:2018
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SIST EN ISO 28158:2018
EN ISO 28158
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2018
EUROPÄISCHE NORM
ICS 97.170 Supersedes EN ISO 28158:2010
English Version
Dentistry - Integrated dental floss and handles (ISO
28158:2018)

Médecine bucco-dentaire - Porte-fil et fil dentaire Zahnheilkunde - Zahnseide im Halter (ISO

intégré (ISO 28158:2018) 28158:2018)
This European Standard was approved by CEN on 13 August 2018.

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, Serbia, 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: Rue de la Science 23, B-1040 Brussels

© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 28158:2018 E

worldwide for CEN national Members.
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SIST EN ISO 28158:2018
EN ISO 28158:2018 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 28158:2018
EN ISO 28158:2018 (E)
European foreword

This document (EN ISO 28158:2018) 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 2019, and conflicting national standards shall be

withdrawn at the latest by April 2019.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 28158:2010.

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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 28158:2018 has been approved by CEN as EN ISO 28158:2018 without any modification.

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SIST EN ISO 28158:2018
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SIST EN ISO 28158:2018
INTERNATIONAL ISO
STANDARD 28158
Second edition
2018-09
Dentistry — Integrated dental floss
and handles
Médecine bucco-dentaire — Porte-fil et fil dentaire intégré
Reference number
ISO 28158:2018(E)
ISO 2018
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SIST EN ISO 28158:2018
ISO 28158:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 28158:2018
ISO 28158:2018(E)
Contents  Page

Foreword ........................................................................................................................................................................................................................................iv

1  Scope ................................................................................................................................................................................................................................. 1

2  Normative references ...................................................................................................................................................................................... 1

3  Terms and definitions ..................................................................................................................................................................................... 1

4  Requirements .......................................................................................................................................................................................................... 2

4.1 Material and shape .............................................................................................................................................................................. 2

4.1.1 Material .................................................................................................................................................................................... 2

4.1.2 Shape .......................................................................................................................................................................................... 2

4.2 Strength ......................................................................................................................................................................................................... 2

4.2.1 General...................................................................................................................................................................................... 2

4.2.2 Strength determined by static test ................................................................................................................... 2

4.2.3 Strength determined by tensile test ................................................................................................................ 2

5  Sampling ........................................................................................................................................................................................................................ 2

6  Test conditions and visual inspection ............................................................................................................................................ 2

6.1 Test conditions ........................................................................................................................................................................................ 2

6.2 Visual inspection ................................................................................................................................................................................... 2

7 Packaging ..................................................................................................................................................................................................................... 3

8  Accompanying information ....................................................................................................................................................................... 3

8.1 Labelling of the package ................................................................................................................................................................. 3

8.2 Instructions for use ............................................................................................................................................................................. 3

Annex A (normative) Determination of the strength of integrated dental floss and handles

by static test ............................................................................................................................................................................................................... 4

Annex B (normative) Determination of the strength of integrated dental floss and handles

by tensile test ........................................................................................................................................................................................................... 9

Bibliography .............................................................................................................................................................................................................................14

© ISO 2018 – All rights reserved iii
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SIST EN ISO 28158:2018
ISO 28158:2018(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

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

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

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 (see 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

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso

.org/iso/foreword .html.

This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral

care products.

This second edition cancels and replaces the first edition (ISO 28158:2010), which has been technically

revised.
The main changes compared to the previous edition are as follows:

— inclusion of the alternative test method for the strength of the products using a tensile test equipment

(e.g. push-pull force gauge, tensile testing equipment or equivalent);

— addition of the requirement that having no displacement which is more than 10 mm of the loading

point in the direction of the loading at the force of 10 N;

— addition of the directions for procedure of tooth cleaning using the integrated dental floss and

handles, if necessary, and a recommendation on safety information recommending the user to apply

a gentle “sawing” or “zig-zag” motion of the floss during insertion into and removal of the floss from

the area between teeth to reduce possible injury to the interdental gingiva potentially caused by the

floss snapping forcefully into the soft gingival tissue.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2018 – All rights reserved
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SIST EN ISO 28158:2018
INTERNATIONAL STANDARD ISO 28158:2018(E)
Dentistry — Integrated dental floss and handles
1  Scope

This document specifies the requirements and test methods for integrated dental floss and handles

used for home care, community care, professional care of oral health or a part of dental treatment.

This document is applicable to integrated dental floss and handles for manual use. It does not include

dental floss and handles which contain a continuous supply of dental floss, or handles to which the floss

is subsequently added.

This document excludes specific qualitative and quantitative test methods for demonstrating freedom

from unacceptable biological risks. For assessment of such biological risks, see ISO 10993-1 and ISO 7405.

2  Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 1942, Dentistry — Vocabulary

ISO 3696:1987, Water for analytical laboratory use — Specification and test methods

3  Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
dental floss

multiple filaments gathered into thread, spun yarn, single filament or tape, commonly synthetic fibre,

with or without coating material(s), designed for the removal of plaque and/or debris from the proximal

surfaces of natural or artificial teeth and the gingival surfaces of pontics of fixed prostheses

[SOURCE: ISO 1942:2009, 2.69, modified]
3.2
integrated dental floss and handle
oral hygiene device holding dental floss (3.1) as a fixed integral part
© ISO 2018 – All rights reserved 1
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SIST EN ISO 28158:2018
ISO 28158:2018(E)
4  Requirements
4.1  Material and shape
4.1.1 Material

The dental floss and handle shall be free from extraneous matter when examined according to 6.2 a).

Materials intentionally added to dental floss or handle such as wax, pigments or flavouring agents, shall

be considered as part of the device.
4.1.2  Shape

The integrated dental floss and handle shall not have any sharp surface, burr or parts when examined

according to 6.2 b), except when a part, if included, is designed and intended to be used as a tooth pick.

4.2 Strength
4.2.1 General

The integrated dental floss and handle shall be in accordance with the requirement prescribed in 4.2.2

or 4.2.3.
4.2.2  Strength determined by static test

The integrated dental floss and handle shall withstand the static load of 10 N for 10 s without a breakage

of the floss or handle, a pull-out of the floss from the handle or displacement of more than 10 mm of

the loading point in the direction of the loading when determined in accordance with the test method

specified in Annex A.
4.2.3  Strength determined by tensile test

The integrated dental floss and handle shall withstand the load of 10 N applied by a tensile testing

equipment without a breakage of the floss or handle, a pull-out of the floss from the handle or a

displacement of more than 10 mm of the loading point in the direction of the loading when determined

in accordance with the test method specified in Annex B.
5  Sampling

Obtain a sufficient number of test specimens which are identical to the marketed product t

...

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