EN ISO 16954:2015

Dentistry - Test methods for dental unit waterline biofilm treatment (ISO 16954:2015)

ISO 16954:2015 provides type test methods for evaluating the effectiveness of treatment methods intended to prevent or inhibit the formation of biofilm or to remove biofilm present in dental unit procedural water delivery systems under laboratory conditions.
It does not apply to devices intended to deliver sterile procedural water or sterile solution. It also does not apply to lines, tubing, or hoses that deliver compressed air within the dental unit.
It does not establish specific upper limits for bacterial contamination or describe test methods to be used in clinical situations. It also does not establish test methods for evaluating any deleterious side effects potentially caused by treatment methods.
The test methods provided in ISO 16954:2015 can be used to test other dental equipment that delivers non-sterile water to the oral cavity.

Zahnheilkunde - Prüfverfahren zur Biofilmbehandlung der wasserführenden Leitungen einer zahnärztlichen Behandlungseinheit (ISO 16954:2015)

Diese Internationale Norm legt Prüfverfahren für Typprüfungen zur Bewertung der Wirksamkeit von Behandlungsverfahren fest, mit denen unter Laborbedingungen in den Wasserversorgungssystemen der zahnärztlichen Behandlungseinheiten die Bildung von Biofilm verhindert oder gehemmt werden soll oder mit denen ein vorhandener Biofilm entfernt werden soll.
Diese Internationale Norm gilt nicht für Produkte, die dazu vorgesehen sind, steriles Behandlungswasser oder Sterillösungen abzugeben. Ebenso gilt sie nicht für Leitungen, Rohre oder Schläuche, die Druckluft innerhalb der zahnärztlichen Behandlungseinheit bereitstellen.
Diese Internationale Norm legt keine spezifischen Obergrenzen für bakterielle Verunreinigungen fest, oder beschreibt die in klinischen Situationen anzuwendenden Prüfverfahren. Die Norm legt auch keine Prüfver-fahren zur Bewertung schädlicher Nebenwirkungen fest, die möglicherweise durch die Behandlungs-verfahren verursacht wurden.
Die in dieser Internationalen Norm beschriebenen Prüfverfahren können zur Prüfung von anderen zahnärztlichen Ausrüstungen, die nicht-steriles Wasser in die Mundhöhle abgeben, verwendet werden.

Médecine bucco-dentaire - Méthodes d'essais pour le traitement du biofilm dans les conduites d'eau de l'unit dentaire (ISO 16954:2015)

L'ISO 16954:2015 propose des méthodes d'essai classiques pour évaluer l'efficacité de méthodes de traitement destinées à prévenir ou inhiber la formation de biofilm ou à éliminer le biofilm présent dans les systèmes d'alimentation en eau à usage opératoire de l'unit dentaire dans des conditions de laboratoire.
Elle ne s'applique pas aux dispositifs conçus pour fournir de l'eau à usage opératoire stérile ou une solution stérile. Elle ne s'applique pas non plus aux tubulures, tuyaux ou conduites envoyant de l'air comprimé dans l'unit dentaire.
L'ISO 16954:2015 n'établit pas de limites supérieures spécifiques pour la contamination bactérienne et ne décrit pas les méthodes d'essai à utiliser dans un contexte clinique. Elle n'établit pas non plus les méthodes d'essai permettant d'évaluer les effets secondaires délétères potentiellement causés par des méthodes de traitement.
Les méthodes d'essai décrites dans l'ISO 16954:2015 peuvent être utilisées pour soumettre à essai tout autre matériel dentaire envoyant de l'eau non stérile dans la cavité buccale.

Zobozdravstvo - Preskusne metode za ravnanje z vodo v zobozdravstvenih enotah po načinu biofilma (ISO 16954:2015)

Ta standard določa tipe preskusnih metod za ovrednotenje učinkovitosti metod zdravljenja, ki so namenjene izboljšanju ali ohranjanju mikrobiološke kakovosti proceduralne vode iz zobozdravstvenih enot pri laboratorijskih pogojih. Ta standard ne velja za naprave, ki so namenjene zagotavljanju sterilne proceduralne vode ali sterilnih raztopin. Ravno tako ne velja za linije, cevi ali gibke cevi za dobavo stisnjenega zraka znotraj zobozdravstvene enote.  Ta standard ne določa posebnih zgornjih mejnih vrednosti za mikrobiološko onesnaženje ali opisane preskusne metode za uporabo v kliničnih situacijah. Ravno tako ne določa preskusnih metod za oceno kakršnih koli škodljivih stranskih učinkov, ki bi jih lahko povzročile metode zdravljenja.  Preskusne metode, ki so določene v tem mednarodnem standardu, so lahko uporabljene za preskušanje druge zobozdravstvene opreme, ki dobavlja nesterilno vodo v ustno votlino.

General Information

• Status: Published
• Publication Date: 07-Jul-2015
• Withdrawal Date: 30-Jan-2016
• ICS: 11.060.20 - Dental equipment
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 08-Jul-2015
• Due Date: 03-Apr-2015
• Completion Date: 08-Jul-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 16954:2015 - Dentistry - Test methods for dental unit waterline biofilm treatment (ISO 16954:2015)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16954:2015
01-september-2015
=RER]GUDYVWYR3UHVNXVQHPHWRGH]DUDYQDQMH]YRGRY]RER]GUDYVWYHQLKHQRWDK
SRQDþLQXELRILOPD,62
Dentistry - Test methods for dental unit waterline biofilm treatment (ISO 16954:2015)
Zahnheilkunde - Prüfverfahren zur Biofilmbehandlung der wasserführenden Leitungen
einer dentalen Behandlungseinheit (ISO 16954:2015)
Médecine bucco-dentaire - Méthodes d'essais pour le traitement du biofilm dans les
conduites d'eau de l'unit dentaire (ISO 16954:2015)
Ta slovenski standard je istoveten z: EN ISO 16954:2015
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 16954:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16954:2015

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SIST EN ISO 16954:2015

EUROPEAN STANDARD
EN ISO 16954

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2015
ICS 11.060.20
English Version
Dentistry - Test methods for dental unit waterline biofilm
treatment (ISO 16954:2015)
Médecine bucco-dentaire - Méthodes d'essais pour le Zahnheilkunde - Prüfverfahren zur Biofilmbehandlung der
traitement du biofilm dans les conduites d'eau de l'unit wasserführenden Leitungen einer dentalen
dentaire (ISO 16954:2015) Behandlungseinheit (ISO 16954:2015)
This European Standard was approved by CEN on 23 April 2015.

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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16954:2015 E
worldwide for CEN national Members.

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SIST EN ISO 16954:2015
EN ISO 16954:2015 (E)
Contents Page
European foreword .3

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SIST EN ISO 16954:2015
EN ISO 16954:2015 (E)
European foreword
This document (EN ISO 16954:2015) 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 January 2016, and conflicting national standards shall be withdrawn at
the latest by January 2016.
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 16954:2015 has been approved by CEN as EN ISO 16954:2015 without any modification.

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SIST EN ISO 16954:2015

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SIST EN ISO 16954:2015
INTERNATIONAL ISO
STANDARD 16954
First edition
2015-07-01
Dentistry — Test methods for dental
unit waterline biofilm treatment
Médecine bucco-dentaire — Méthodes d’essais pour le traitement du
biofilm dans
...