Dentistry - Tissue punches (ISO 23445:2021)

This document specifies requirements and their test methods for tissue punches used with a handpiece in dentistry especially for oral surgical implant procedures such as cutting holes or notches in and removing of gingival tissue. It also specifies the requirements for their marking and labelling.

Zahnheilkunde - Gewebestanzen (ISO 23445:2021)

Dieses Dokument beschreibt Anforderungen und dazugehörige Prüfverfahren für Gewebestanzen, die mit einem Handstück in der Zahnheilkunde verwendet werden, besonders für oralchirurgische Implantationsverfahren wie zum Ausstanzen von Löchern oder Kerben in und zum Entfernen des Gingivagewebes. Es legt zudem die Anforderungen zur Markierung und Kennzeichnung fest.

Médecine bucco-dentaire - Bistouris circulaires (ISO 23445:2021)

Zobozdravstvo - Instrumenti za posege v tkivo (ISO 23445:2021)

General Information

Status
Published
Public Enquiry End Date
19-Jun-2020
Publication Date
29-Jun-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Jun-2021
Due Date
16-Aug-2021
Completion Date
30-Jun-2021

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SLOVENSKI STANDARD
SIST EN ISO 23445:2021
01-september-2021
Zobozdravstvo - Instrumenti za posege v tkivo (ISO 23445:2021)
Dentistry - Tissue punches (ISO 23445:2021)
Zahnheilkunde - Gewebestanzen (ISO 23445:2021)
Médecine bucco-dentaire - Bistouris circulaires (ISO 23445:2021)
Ta slovenski standard je istoveten z: EN ISO 23445:2021
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
SIST EN ISO 23445:2021 en

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

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SIST EN ISO 23445:2021
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SIST EN ISO 23445:2021
EN ISO 23445
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2021
EUROPÄISCHE NORM
ICS 11.060.25
English Version
Dentistry - Tissue punches (ISO 23445:2021)

Médecine bucco-dentaire - Bistouris circulaires (ISO Zahnheilkunde - Gewebestanzen (ISO 23445:2021)

23445:2021)
This European Standard was approved by CEN on 2 May 2021.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, 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

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23445:2021 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 23445:2021
EN ISO 23445:2021 (E)
Contents Page

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

---------------------- Page: 4 ----------------------
SIST EN ISO 23445:2021
EN ISO 23445:2021 (E)
European foreword

This document (EN ISO 23445:2021) 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 November 2021, and conflicting national standards

shall be withdrawn at the latest by November 2021.

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.

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, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 23445:2021 has been approved by CEN as EN ISO 23445:2021 without any modification.

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SIST EN ISO 23445:2021
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SIST EN ISO 23445:2021
INTERNATIONAL ISO
STANDARD 23445
First edition
2021-04
Dentistry — Tissue punches
Médecine bucco-dentaire — Bistouris circulaires
Reference number
ISO 23445:2021(E)
ISO 2021
---------------------- Page: 7 ----------------------
SIST EN ISO 23445:2021
ISO 23445:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 23445:2021
ISO 23445:2021(E)
Contents Page

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

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

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

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

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

4 Symbols .......................................................................................................................................................................................................................... 2

5 Classification ............................................................................................................................................................................................................ 2

6 Requirements .......................................................................................................................................................................................................... 3

6.1 Selection of metals ............................................................................................................................................................................... 3

6.2 Surface finish ............................................................................................................................................................................................ 3

6.3 Dimensions ................................................................................................................................................................................................. 3

6.3.1 Diameter of the working part and centre-guide ................................................................................... 3

6.3.2 Length of the working part ..................................................................................................................................... 3

6.3.3 Overall length ...................................................................... ................................................................................................ 3

6.3.4 Dimensions of the shank ........................................................................................................................................... 3

6.4 Resistance to reprocessing ........................................................................................................................................................... 4

6.5 Hardness ....................................................................................................................................................................................................... 4

6.6 Run-out .......................................................................................................................................................................................................... 4

7 Measurement and test methods ........................................................................................................................................................... 4

7.1 Visual inspection ................................................................................................................................................................................... 4

7.2 Dimensions ................................................................................................................................................................................................. 4

7.3 Resistance to reprocessing ........................................................................................................................................................... 4

7.4 Hardness ....................................................................................................................................................................................................... 4

7.5 Run-out .......................................................................................................................................................................................................... 4

8 Marking, labelling and instructions for use ............................................................................................................................. 5

8.1 Marking on the tissue punch ....................................................................................................................................................... 5

8.2 Labelling on the package ...................................................................................................

...

SLOVENSKI STANDARD
oSIST prEN ISO 23445:2020
01-junij-2020
Zobozdravstvo - Instrumenti za posege v tkivo (ISO/DIS 23445:2020)
Dentistry - Tissue punches (ISO/DIS 23445:2020)
Zahnheilkunde - Gewebestanzen (ISO/DIS 23445:2020)
Médecine bucco-dentaire - Poincon de tissu (ISO/DIS 23445:2020)
Ta slovenski standard je istoveten z: prEN ISO 23445
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
oSIST prEN ISO 23445:2020 en

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

---------------------- Page: 1 ----------------------
oSIST prEN ISO 23445:2020
---------------------- Page: 2 ----------------------
oSIST prEN ISO 23445:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23445
ISO/TC 106/SC 4 Secretariat: DIN
Voting begins on: Voting terminates on:
2020-04-15 2020-07-08
Dentistry — Tissue punches
Médecine bucco-dentaire — Poincon de tissu
ICS: 11.060.25
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 23445:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
---------------------- Page: 3 ----------------------
oSIST prEN ISO 23445:2020
ISO/DIS 23445:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 23445:2020
ISO/DIS 23445:2020(E)
Contents Page

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

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

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

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

3 Terms, definitions and symbols ............................................................................................................................................................ 1

3.1 Terms and definitions ....................................................................................................................................................................... 1

3.2 Symbols ......................................................................................................................................................................................................... 2

4 Classification ............................................................................................................................................................................................................ 2

5 Requirements .......................................................................................................................................................................................................... 3

5.1 Selection of metals ............................................................................................................................................................................... 3

5.2 Surface finish ............................................................................................................................................................................................ 3

5.3 Dimensions ................................................................................................................................................................................................. 3

5.3.1 Diameter of the working part and centre-guide ................................................................................... 3

5.3.2 Length of the working part ..................................................................................................................................... 3

5.3.3 Overall length ...................................................................... ................................................................................................ 3

5.3.4 Dimensions of the shank ........................................................................................................................................... 4

5.4 Marking lines on the operative part ..................................................................................................................................... 4

5.4.1 General...................................................................................................................................................................................... 4

5.4.2 Thickness of scale line ........................................................................................................................................... ...... 4

5.5 Resistance to reprocessing ........................................................................................................................................................... 4

5.6 Hardness ....................................................................................................................................................................................................... 4

5.7 Run-out .......................................................................................................................................................................................................... 4

6 Measurement and test methods ........................................................................................................................................................... 4

6.1 Visual inspection ................................................................................................................................................................................... 4

6.2 Dimensions ................................................................................................................................................................................................. 4

6.3 Resistance to reprocessing ........................................................................................................................................................... 4

6.4 Hardness ....................................................................................................................................................................................................... 5

6.5 Run-out .......................................................................................................................................................................................................... 5

7 Marking, labelling and instructions for use ............................................................................................................................. 5

7.1 Marking on the tissue punch ....................................................................................................................................................... 5

7.2 Labelling on the package ................................................................................................................................................................ 5

7.3 Instructions for use ............................................................................................................................................................................. 6

© ISO 2020 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 23445:2020
ISO/DIS 23445:2020(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 o

...

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