Dentistry - Oral surgical scalpel handle (ISO 20570:2018)

This International Standard specifies requirements and their test methods for oral surgical scalpel handles used in dentistry especially for oral surgical procedures such as gingival tissue cutting and making surgical incisions. It also specifies the requirements for their marking and labelling.

Zahnheilkunde - Oralchirurgische Skalpellgriffe (ISO 20570:2018)

Médecine bucco-dentaire - Manche de bistouri pour chirurgie buccale (ISO 20570:2018)

Le présent document spécifie les exigences et méthodes d'essai applicables à diverses utilisations de manches de bistouri pour chirurgie buccale employés avec des lames détachables dans le cadre de certaines procédures de chirurgie buccale, comme la taille et/ou l'extraction de tissus buccaux mous.
Il spécifie également les exigences applicables au marquage et à l'étiquetage des manches de bistouri pour chirurgie buccale.

Zobozdravstvo - Držalo skalpela za oralno kirurgijo (ISO 20570:2018)

Ta mednarodni standard določa zahteve in povezane preskusne metode za držala skalpela za oralno kirurgijo, ki se v zobozdravstvu uporabljajo zlasti pri oralnih kirurških postopkih, na primer rezanju gingivalnega tkiva in kirurškemu zarezovanju. Določa tudi zahteve za označevanje in etiketiranje.

General Information

Status
Published
Public Enquiry End Date
09-Jul-2017
Publication Date
13-Nov-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
05-Nov-2018
Due Date
10-Jan-2019
Completion Date
14-Nov-2018

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SLOVENSKI STANDARD
SIST EN ISO 20570:2018
01-december-2018
Zobozdravstvo - Držalo skalpela za oralno kirurgijo (ISO 20570:2018)
Dentistry - Oral surgical scalpel handle (ISO 20570:2018)
Zahnheilkunde - Oralchirurgische Skalpellgriffe (ISO 20570:2018)

Médecine bucco-dentaire - Manche de bistouri pour chirurgie buccale (ISO 20570:2018)

Ta slovenski standard je istoveten z: EN ISO 20570:2018
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 20570:2018 en

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

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SIST EN ISO 20570:2018
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SIST EN ISO 20570:2018
EN ISO 20570
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2018
EUROPÄISCHE NORM
ICS 11.060.20
English Version
Dentistry - Oral surgical scalpel handle (ISO 20570:2018)

Médecine bucco-dentaire - Manche de bistouri pour Zahnheilkunde - Oralchirurgische Skalpellgriffe (ISO

chirurgie buccale (ISO 20570:2018) 20570:2018)
This European Standard was approved by CEN on 10 August 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 20570:2018 E

worldwide for CEN national Members.
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SIST EN ISO 20570:2018
EN ISO 20570:2018 (E)
Contents Page

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

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SIST EN ISO 20570:2018
EN ISO 20570:2018 (E)
European foreword

This document (EN ISO 20570:2018) 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 April 2019, and conflicting national standards shall be

withdrawn at the latest by April 2019.

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, 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 20570:2018 has been approved by CEN as EN ISO 20570:2018 without any modification.

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SIST EN ISO 20570:2018
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SIST EN ISO 20570:2018
INTERNATIONAL ISO
STANDARD 20570
First edition
2018-09
Dentistry — Oral surgical scalpel
handle
Médecine bucco-dentaire — Manche de bistouri pour chirurgie buccale
Reference number
ISO 20570:2018(E)
ISO 2018
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SIST EN ISO 20570:2018
ISO 20570:2018(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
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 2018 – All rights reserved
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SIST EN ISO 20570:2018
ISO 20570:2018(E)
Contents Page

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

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

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

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

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

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

5 Requirements .......................................................................................................................................................................................................... 2

5.1 Shape ............................................................................................................................................................................................................... 2

5.2 Dimensions ................................................................................................................................................................................................. 4

5.2.1 Maximum overall length ........................................................................................................................................... . 4

5.2.2 Dimensions of fitting feature ................................................................................................................................. 4

5.2.3 Dimensions of the shank ........................................................................................................................................... 4

5.2.4 Angle between the handle and the working tip .................................................................................... 4

5.3 Materials ....................................................................................................................................................................................................... 4

5.4 Surface finish ............................................................................................................................................................................................ 4

5.5 Resistance to reprocessing ........................................................................................................................................................... 5

5.6 Hardness ....................................................................................................................................................................................................... 5

5.7 Security of attachment ..................................................................................................................................................................... 5

6 Measurement and test methods ........................................................................................................................................................... 5

6.1 Measurement of dimensions ....................................................................................................................................................... 5

6.2 Test on surface finish ......................................................................................................................................................................... 5

6.3 Test on resistance to reprocessing ......................................................................................................................................... 5

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

6.5 Security of attachment ..................................................................................................................................................................... 5

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

7.1 Marking on the scalpel handle ................................................................................................................................................... 5

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

...

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