EN ISO 21563:2013

Dentistry - Hydrocolloid impression materials (ISO 21563:2013)

ISO 21563:2013 specifies the requirements and tests for helping determine whether the elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use.

Zahnheilkunde - Hydrokolloidabformmaterialien (ISO 21563:2013)

Diese Internationale Norm legt Anforderungen und Prüfverfahren fest, mit denen ermittelt werden kann, ob die in der Zahnheilkunde verwendeten elastischen Agar- und Alginat-Hydrokolloidabformmaterialien auf Wasserbasis, so wie sie im Einzelhandel verkauft werden, über die Qualität verfügen, die für ihre Anwendung benötigt wird. Sie enthält auch Anforderungen an die Kennzeichnung und an die Gebrauchsanweisung.
ANMERKUNG In dieser Internationalen Norm werden keine besonderen qualitativen und quantitativen Anforderungen zum Ausschluss biologischer Risiken gestellt. Zur Beurteilung möglicher biologischer Risiken wird empfohlen, ISO 7405 und ISO 10993 heranzuziehen.

Médecine bucco-dentaire - Produits pour empreintes à base d'hydrocolloïdes (ISO 21563:2013)

L'ISO 21563:2013 spécifie les exigences et essais permettant de déterminer si les produits pour empreintes dentaires à base d'hydrocolloïde d'alginate et d'agar-agar aqueux et élastiques, tels qu'ils sont préparés pour la commercialisation au détail, présentent la qualité requise aux fins recherchées. Elle spécifie également les exigences relatives à l'étiquetage et la notice d'utilisation.

Zobozdravstvo - Hidrokoloidni materiali za oblikovanje (odtise) (ISO 21563:2013)

Ta mednarodni standard določa zahteve in preskuse za ugotavljanje, ali hidrokoloidni materiali za dentalno oblikovanje (elastični vodni agar in alginat), kot so pripravljeni za trženje v prodaji na drobno, izpolnjujejo zahteve glede kakovosti, potrebne za njihovo predvideno uporabo. Prav tako določa zahteve za označevanje in navodila za uporabo.

General Information

• Status: Withdrawn
• Publication Date: 20-Aug-2013
• Withdrawal Date: 14-Sep-2021
• ICS: 11.060.10 - Dental materials
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 15-Sep-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 21563:2013 - Dentistry - Hydrocolloid impression materials (ISO 21563:2013)

Relations

• Replaces: EN ISO 13716:2000 - Dentistry - Reversible-irreversible hydrocolloid impression material systems (ISO 13716:1999)
• Effective Date: 08-Jun-2022
• Replaces: EN 21563:1991 - Alginate dental impression material (ISO 1563:1990)
• Effective Date: 28-Aug-2013
• Replaces: EN ISO 1564:1998 - Dental aqueous impression materials based on agar (ISO 1564:1995)
• Effective Date: 24-Apr-2013
• Replaced By: EN ISO 21563:2021 - Dentistry - Hydrocolloid impression materials (ISO 21563:2021)
• Effective Date: 13-Feb-2019

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 21563:2013
01-november-2013
1DGRPHãþD
SIST EN 21563:2000
SIST EN ISO 13716:2001
SIST EN ISO 1564:2000
Zobozdravstvo - Hidrokoloidni materiali za oblikovanje (odtise) (ISO 21563:2013)
Dentistry - Hydrocolloid impression materials (ISO 21563:2013)
Zahnheilkunde - Hydrokolloidabformmassen (ISO 21563:2013)
Médecine bucco-dentaire - Matériaux d'impression hydrocolloïde (ISO 21563:2013)
Ta slovenski standard je istoveten z: EN ISO 21563:2013
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 21563:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 21563:2013

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SIST EN ISO 21563:2013


EUROPEAN STANDARD
EN ISO 21563

NORME EUROPÉENNE

EUROPÄISCHE NORM
August 2013
ICS 11.060.10 Supersedes EN 21563:1991, EN ISO 13716:2000, EN
ISO 1564:1998
English Version
Dentistry - Hydrocolloid impression materials (ISO 21563:2013)
Médecine bucco-dentaire - Produits pour empreintes à Zahnheilkunde - Hydrokolloidabformmassen (ISO
base d'hydrocolloïdes (ISO 21563:2013) 21563:2013)
This European Standard was approved by CEN on 22 June 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 21563:2013: E
worldwide for CEN national Members.

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SIST EN ISO 21563:2013
EN ISO 21563:2013 (E)
Contents Page
Foreword .3
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SIST EN ISO 21563:2013
EN ISO 21563:2013 (E)
Foreword
This document (EN ISO 21563:2013) 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 February 2014, and conflicting national standards shall be withdrawn
at the latest by February 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.
This document supersedes EN 21563:1991, EN ISO 13716:2000, EN ISO 1564:1998.
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 21563:2013 has been approved by CEN as EN ISO 21563:2013 without any modification.


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SIST EN ISO 21563:2013

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SIST EN ISO 21563:2013
INTERNATIONAL ISO
STANDARD 21563
First edition
2013-08-15
Dentistry — Hydrocolloid impression
materials
Médecine bucco-dentaire — Produits pour empreintes à base
d’hydrocolloïdes
Reference number
ISO 21563:2013(E)
©
ISO 2013

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SIST EN ISO 21563:2013
ISO 215
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