EN ISO 28158:2010

Dentistry - Integrated dental floss and handles (ISO 28158:2010)

ISO 28158:2010 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 dental floss and handles to which the floss is subsequently added.
ISO 28158:2010 does not specify specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological risks.

Zahnheilkunde - Zahnseide im Halter (ISO 28158:2010)

Diese Internationale Norm gilt für Zahnseide im Halter, die manuell angewandt werden. Sie gilt nicht für
Zahnseide und Halter mit kontinuierlicher Zahnseidenzuführung oder für Zahnseide und Halter, in die später
Zahnseide eingelegt wird.
In dieser Internationalen Norm werden keine besonderen qualitativen und quantitativen Anforderungen zum
Ausschluss biologischer Risiken gestellt. Zur Beurteilung möglicher biologischer Risiken wird empfohlen,
ISO 10993-1 und ISO 7405 heranzuziehen.

Médecine bucco-dentaire - Porte-fil et fil dentaire intégré (ISO 28158:2010)

L'ISO 28158:2010 s'applique aux porte-fils et fils dentaires intégrés destinés à une utilisation manuelle. Elle ne traite pas des porte-fils et fils dentaires qui contiennent une alimentation continue de fil dentaire, ni des porte-fils et fils dentaires auxquels le fil est ajouté par la suite.
L'ISO 28158:2010 ne spécifie aucune méthode d'essai qualitative ou quantitative spécifique visant à démontrer l'absence de risques biologiques inacceptables.

Zobozdravstvo - Držala z (vpeto) zobno nitko (ISO 28158:2010)

Ta mednarodni standard velja za držala z (vpeto) zobno nitko za ročno uporabo. Ne vključuje zobnih nitk in ročajev, ki vsebujejo stalno oskrbo z zobno nitko, ali zobnih nitk in ročajev, kamor se zobna nitka vstavi naknadno. Ta mednarodni standard ne določa posebnih kakovostnih in količinskih preskusnih metod 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• Status: Withdrawn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-Jun-2010
• Withdrawal Date: 23-Oct-2018
• ICS: 97.170 - Body care equipment
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 24-Oct-2018
• Ref Project: SIST EN ISO 28158:2010 - Dentistry - Integrated dental floss and handles (ISO 28158:2010)

Relations

• Replaced By: EN ISO 28158:2018 - Dentistry - Integrated dental floss and handles (ISO 28158:2018)
• Effective Date: 31-Oct-2018

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Zobozdravstvo - Držala z (vpeto) zobno nitko (ISO 28158:2010)Zahnheilkunde - Vorgespannte Zahnseiden mit Griff (ISO 28158:2010)Médecine bucco-dentaire - Porte-fil et fil dentaire intégré (ISO 28158:2010)Dentistry - Integrated dental floss and handles (ISO 28158:2010)97.170Oprema za nego telesaBody care equipmentICS:Ta slovenski standard je istoveten z:EN ISO 28158:2010SIST EN ISO 28158:2010en01-oktober-2010SIST EN ISO 28158:2010SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 28158
July 2010 ICS 97.170 English Version
Dentistry - Integrated dental floss and handles (ISO 28158:2010)
Médecine bucco-dentaire - Porte-fil et fil dentaire intégré (ISO 28158:2010)
Zahnheilkunde - Vorgespannte Zahnseiden mit Griff (ISO 28158:2010) This European Standard was approved by CEN on 9 June 2010.
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 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 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 28158:2010: ESIST EN ISO 28158:2010

Reference numberISO 28158:2010(E)© ISO 2010
INTERNATIONAL STANDARD ISO28158First edition2010-07-01Dentistry — Integrated dental floss and handles Médecine bucco-dentaire — Porte-fil et fil dentaire intégré
ISO 28158:2010(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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ii © ISO 2010 – All rights reserved
ISO 28158:2010(E) © ISO 2010 – All rights reserved iii 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. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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. ISO 28158 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care products. SIST EN ISO 28158:2010

ISO 28158:2010(E) iv © ISO 2010 – All rights reserved Introduction This International Standard has been prepared in order to present the requirements and test methods for integrated dental floss and handles used for home care, community care, professional care of oral health or as a part of dental treatment.
INTERNATIONAL STANDARD ISO 28158:2010(E) © ISO 2010 – All rights reserved 1 Dentistry — Integrated dental floss and handles 1 Scope This International Standard 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 dental floss and handles to which the floss is subsequently added. This International Standard does not specify 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 referenced documents are indispensable for the application 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 1942:2009, Dentistry — Vocabulary ISO 3696, 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. 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 fo
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