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CEN

EN ISO 28158:2018

(Main)

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

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
Published
Publication Date
23-Oct-2018
Withdrawal Date
29-Apr-2019
ICS
97.170 - Body care equipment
Technical Committee
CEN/TC 55 - Dentistry
Drafting Committee
CEN/TC 55 - Dentistry
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
24-Oct-2018
Completion Date
24-Oct-2018
Ref Project
SIST EN ISO 28158:2018 - Dentistry - Integrated dental floss and handles (ISO 28158:2018)

Relations

Replaces
EN ISO 28158:2010 - Dentistry - Integrated dental floss and handles (ISO 28158:2010)
Effective Date
31-Oct-2018

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Standards Content (Sample)

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

2

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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.

3

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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

---------------------- Page: 7 ----------------------

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
...

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