Dentistry - Dental amalgam reusable mixing-capsules (ISO 13897:2018)

ISO 13897:2018 specifies the requirements for reusable mixing-capsules intended to contain dental amalgam alloy powder and dental mercury when these are mixed to produce dental amalgam, and the test methods used to determine conformity to these requirements.
NOTE       ISO 7488 specifies requirements for mixing machines. The requirements for mixing-capsule are not dealt with in ISO 7488, although the mixing-capsule is an essential part of the mixing machine.

Zahnheilkunde - Wiederverwendbare Mischkapseln für zahnärztliches Amalgam (ISO 13897:2018)

Médecine bucco-dentaire - Capsules de mélange réutilisables pour amalgame dentaire (ISO 13897:2018)

ISO 13897:2018 spécifie les exigences applicables aux capsules de mélange réutilisables conçues pour contenir de la poudre d'alliage pour amalgame dentaire et du mercure à usage dentaire lorsqu'ils sont mélangés pour produire un amalgame dentaire. Il décrit également les méthodes d'essai utilisées pour déterminer la conformité à ces exigences.
NOTE       L'ISO 7488 spécifie les exigences relatives aux mélangeurs. Bien que la capsule de mélange soit une partie essentielle du mélangeur, les exigences relatives à la capsule de mélange ne sont pas abordées dans l'ISO 7488.

Zobozdravstvo - Kapsule za ponovno uporabo zobnega amalgama (ISO 13897:2018)

Ta dokument določa zahteve za mešalne kapsule za večkratno uporabo, ki so predvidene za prašek zobnega amalgama in živo srebro za uporabo v zobozdravstvu, ko sta zmešana zaradi ustvarjanja zobnega amalgama, in
preskusne metode za določanje skladnosti s temi zahtevami.
OPOMBA ISO 7488 določa zahteve za mešalne stroje. Zahteve za mešalne kapsule niso obravnavane v standardu ISO 7488, čeprav je mešalna kapsula bistveni del mešalnega stroja.

General Information

Status
Published
Publication Date
27-Feb-2018
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
28-Feb-2018
Completion Date
28-Feb-2018

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SLOVENSKI STANDARD
SIST EN ISO 13897:2018
01-maj-2018
1DGRPHãþD
SIST EN ISO 13897:2004
Zobozdravstvo - Kapsule za ponovno uporabo zobnega amalgama (ISO
13897:2018)
Dentistry - Dental amalgam reusable mixing-capsules (ISO 13897:2018)
Zahnheilkunde - Wiederverwendbare Mischkapseln für zahnärztliches Amalgam (ISO
13897:2018)
Art dentaire - Capsules réutilisables pour mélanger amalgame (ISO 13897:2018)
Ta slovenski standard je istoveten z: EN ISO 13897:2018
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 13897:2018 en

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

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SIST EN ISO 13897:2018
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SIST EN ISO 13897:2018
EN ISO 13897
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2018
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 13897:2004
English Version
Dentistry - Dental amalgam reusable mixing-capsules (ISO
13897:2018)

Médecine bucco-dentaire - Capsules de mélange Zahnheilkunde - Wiederverwendbare Mischkapseln für

réutilisables pour amalgame dentaire (ISO zahnärztliches Amalgam (ISO 13897:2018)

13897:2018)
This European Standard was approved by CEN on 2 February 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 13897:2018 E

worldwide for CEN national Members.
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SIST EN ISO 13897:2018
EN ISO 13897:2018 (E)
Contents Page

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

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SIST EN ISO 13897:2018
EN ISO 13897:2018 (E)
European foreword

This document (EN ISO 13897:2018) 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 August 2018, and conflicting national standards shall

be withdrawn at the latest by August 2018.

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 13897:2004.

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 13897:2018 has been approved by CEN as EN ISO 13897:2018 without any modification.

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SIST EN ISO 13897:2018
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SIST EN ISO 13897:2018
INTERNATIONAL ISO
STANDARD 13897
Second edition
2018-02
Dentistry — Dental amalgam reusable
mixing-capsules
Médecine bucco-dentaire — Capsules de mélange réutilisables pour
amalgame dentaire
Reference number
ISO 13897:2018(E)
ISO 2018
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SIST EN ISO 13897:2018
ISO 13897:2018(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, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 13897:2018
ISO 13897:2018(E)
Contents Page

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

Introduction ..................................................................................................................................................................................................................................v

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

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

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

4 Requirements .......................................................................................................................................................................................................... 1

4.1 Dimensions ................................................................................................................................................................................................. 1

4.1.1 Length tolerance .............................................................................................................................................................. 1

4.1.2 Diameter tolerance ........................................................................................................................................................ 2

4.2 Loss of mass from the mixing-capsule during mixing........................................................................................... 2

4.3 Retention of dental amalgam in the mixing-capsule .............................................................................................. 2

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

6 Measurements and test methods ........................................................................................................................................................ 2

6.1 Dimensions ................................................................................................................................................................................................. 2

6.1.1 Apparatus ............................................................................................................................................................................... 2

6.1.2 Test sample ........................................................................................................................................................................... 2

6.1.3 Procedure ............................................................................................................................................................................... 2

6.1.4 Report ........................................................................................................................................................................................ 3

6.2 Loss of mass from the mixing-capsule during mixing........................................................................................... 3

6.2.1 Principle .................................................................................................................................................................................. 3

6.2.2 Test sample ........................................................................................................................................................................... 3

6.2.3 Apparatus ............................................................................................................................................................................... 3

6.2.4 Test procedure ................................................................................................................................................................... 4

6.2.5 Expression of the results ........................................................................................................................................... 5

6.2.6 Report ........................................................................................................................................................................................ 5

6.3 Retention of dental amalgam in the mixing-capsule .............................................................................................. 5

6.3.1 Principle .................................................................................................................................................................................. 5

6.3.2 Test sample ........................................................................................................................................................................... 6

6.3.3 Apparatus ............................................................................................................................................................................... 6

6.3.4 Test procedure ................................................................................................................................................................... 6

6.3.5 Expression of the results ........................................................................................................................................... 7

6.3.6 Additional testing ............................................................................................................................................................ 8

6.3.7 Report ........................................................................................................................................................................................ 8

7 Labelling ........................................................................................................................................................................................................................ 8

Bibliography ................................................................................................................................................................................................................................ 9

© ISO 2018 – All rights reserved iii
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SIST EN ISO 13897:2018
ISO 13897:2018(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 on 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 the following

URL: www .iso .org/ iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental

equipment.

This second edition cancels and replaces the first edition (ISO 13897:2003) including Technical

Corrigendum 1 (ISO 13897:2003/Cor.1:2003), which has been technically revised.
The main changes compared to the previous edition are as follows:

— the scope has been revised and is now restricted to dental amalgam reusable mixing-capsules;

— classification into two types has been deleted;
— labelling requirements have been updated.

— requirements for single-use capsules are now within the scope of ISO 20749:2017, these being:

— the requirement for surface contamination of the package and the capsule for pre-capsulated

dental amalgam alloy products;
— loss of mass during mixing from single-use capsules;

— the requirement for containers in which single-use capsules are supplied to prevent spillage of

dental mercury leaking from faulty or damaged single-use capsules;
— labelling requirements for pre-capsulated dental amalgam products;

— manufacturer’s instructions regarding conditions of storage and the disposal of single-use

capsules in pre-capsulated dental amalgam products.
iv © ISO 2018 – All rights reserved
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SIST EN ISO 13897:2018
ISO 13897:2018(E)
Introduction

In order to produce dental amalgam, an electrically-powered mixing machine, as described in ISO 7488

is used for mixing dental amalgam alloy powder with dental mercury. In addition, a removable mixing-

capsule is used to contain the dental amalgam alloy and the dental mercury during the mixing process.

NOTE Traditionally, the mixing machine for dental amalgam has been called an amalgamator. The latter is

now a deprecated term.
© ISO 2018 – All rights reserved v
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SIST EN ISO 13897:2018
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SIST EN ISO 13897:2018
INTERNATIONAL STANDARD ISO 13897:2018(E)
Dentistry — Dental amalgam reusable mixing-capsules
1 Scope

This document specifies the requirements for reusable mixing-capsules intended to contain dental

amalgam alloy powder and dental mercury when these are mixed to produce dental amalgam, and the

test methods used to determine conformity to these requirements.

NOTE ISO 7488 specifies requirements for mixing machines. The requirements for mixing-capsule are not

dealt with in ISO 7488, although the mixing-capsule is an essential part of the mixing machine.

2 Normative references

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

constitute 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 7488, Dentistry — Mixing machines for dental amalgam
ISO 24234:2015, Dentistry — Dental amalgam
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
...

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