Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012)

ISO 13504:2012 specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area.
It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system.

Zahnheilkunde - Allgemeine Anforderungen an bei der Implantation verwendete Instrumente und Zubehör (ISO 13504:2012)

Diese Internationale Norm legt die allgemeinen Anforderungen an die Herstellung von Instrumenten und
Zubehör fest, die bei der Implantation von Dentalimplantaten und der Handhabung von Verbindungsteilen im
Schädel-Gesichts-Bereich verwendet werden.
Sie gilt für Instrumente zur Einmalanwendung und zum Mehrfachgebrauch, unabhängig davon, ob sie
handgeführt oder an ein elektrisches Antriebssystem angeschlossen sind.
Sie gilt nicht für das Antriebssystem selbst, noch für Dentalimplantate oder Teile, die mit diesem verbunden
werden können.
Im Bezug auf die Sicherheit legt diese Internationale Norm Anforderungen an das vorgesehene Leistungsvermögen,
an Gestaltungsmerkmale, die Auswahl von Werkstoffen, die Bewertung der Gestaltung, die
Herstellung, die Sterilisation, die Verpackung und an die vom Hersteller bereitzustellenden Angaben fest.

Médecine bucco-dentaire - Exigences générales relatives aux instruments et aux accessoires connexes utilisés en implantologie dentaire (ISO 13504:2012)

L'ISO 13504:2012 spécifie les exigences générales pour la fabrication d'instruments et accessoires connexes pour la pose des implants dentaires et pour les manipulations ultérieures des éléments de raccordement dans la région cranio-faciale.
L'ISO 13504:2012 s'applique aux instruments à usage unique et aux instruments réutilisables, qu'ils soient à commande manuelle ou raccordés à des systèmes commandés par moteur.

Zobozdravstvo - Splošne zahteve za instrumente in pripadajoči pribor, ki se uporablja pri nameščanju in vstavitvi dentalnih vsadkov (implantatov) (ISO 13504:2012)

Ta mednarodni standard določa splošne zahteve za izdelavo instrumentov in pripadajočega pribora, ki se uporablja pri nameščanju in vstavitvi dentalnih vsadkov in nadaljnjem ravnanju s pritrditvenimi deli v kraniofacialnem predelu. Uporablja se za instrumente za enkratno ali ponovno uporabo, ne glede na to, ali so ročni ali priključeni na električni sistem. Ne uporablja se za same električne sisteme ali dentalne vsadke ali dele, ki so namenjeni pritrditvi na dentalni vsadek. V zvezi z varnostjo podaja ta mednarodni standard zahteve za razvrstitev, predvidene lastnosti, zmogljivost, izbiro materialov, vrednotenje zmogljivosti, izdelavo, sterilizacijo in informacije, ki jih zagotovi proizvajalec.

General Information

Status
Published
Publication Date
14-Jul-2012
Technical Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
15-Jul-2012
Completion Date
15-Jul-2012

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SLOVENSKI STANDARD
SIST EN ISO 13504:2012
01-oktober-2012
=RER]GUDYVWYR6SORãQH]DKWHYH]DLQVWUXPHQWHLQSULSDGDMRþLSULERUNLVH
XSRUDEOMDSULQDPHãþDQMXLQYVWDYLWYLGHQWDOQLKYVDGNRY LPSODQWDWRY  ,62


Dentistry - General requirements for instruments and related accessories used in dental

implant placement and treatment (ISO 13504:2012)
Zahnheilkunde - Allgemeine Anforderungen an bei der Implantation verwendete
Instrumente und Zubehör (ISO 13504:2012)

Médecine bucco-dentaire - Exigences générales pour instruments et accessoires utilisés

en implantologie dentaire (ISO 13504:2012)
Ta slovenski standard je istoveten z: EN ISO 13504:2012
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
SIST EN ISO 13504:2012 en

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

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SIST EN ISO 13504:2012
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SIST EN ISO 13504:2012
EUROPEAN STANDARD
EN ISO 13504
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2012
ICS 11.060.25
English Version
Dentistry - General requirements for instruments and related
accessories used in dental implant placement and treatment
(ISO 13504:2012)

Médecine bucco-dentaire - Exigences générales relatives Zahnheilkunde - Allgemeine Anforderungen an bei der

aux instruments et aux accessoires connexes utilisés en Implantation verwendete Instrumente und Zubehör (ISO

implantologie dentaire (ISO 13504:2012) 13504:2012)
This European Standard was approved by CEN on 14 July 2012.

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
Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13504:2012: E

worldwide for CEN national Members.
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SIST EN ISO 13504:2012
EN ISO 13504:2012 (E)
Contents Page

Foreword ..............................................................................................................................................................3

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SIST EN ISO 13504:2012
EN ISO 13504:2012 (E)
Foreword

This document (EN ISO 13504:2012) 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 2013, and conflicting national standards shall be withdrawn at

the latest by January 2013.

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 13504:2012 has been approved by CEN as a EN ISO 13504:2012 without any modification.

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SIST EN ISO 13504:2012
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SIST EN ISO 13504:2012
INTERNATIONAL ISO
STANDARD 13504
First edition
2012-07-15
Dentistry — General requirements for
instruments and related accessories used
in dental implant placement and treatment
Médecine bucco-dentaire — Exigences générales relatives aux
instruments et aux accessoires connexes utilisés en implantologie dentaire
Reference number
ISO 13504:2012(E)
ISO 2012
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SIST EN ISO 13504:2012
ISO 13504:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,

electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s

member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
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SIST EN ISO 13504:2012
ISO 13504:2012(E)
Contents Page

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

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

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

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

3 Terms and definitions ......................................................................................................................................... 2

3.2 Instruments ........................................................................................................................................................... 2

3.3

Stainless steel ...................................................................................................................................................... 2

4 Classification ........................................................................................................................................................ 3

4.1 Intended usage (application) ............................................................................................................................ 3

4.2 Tissue contact ...................................................................................................................................................... 3

4.3 Reprocessing ....................................................................................................................................................... 3

5 Intended performance ........................................................................................................................................ 3

6 Performance attributes ...................................................................................................................................... 3

7 Material selection ................................................................................................................................................ 4

8 Performance evaluation ..................................................................................................................................... 4

8.1 General ................................................................................................................................................................... 4

8.2 Pre-clinical evaluation ........................................................................................................................................ 4

8.3 Clinical evaluation ............................................................................................................................................... 4

9 Manufacturing ...................................................................................................................................................... 5

9.1 General ................................................................................................................................................................... 5

9.2 Technical documentation .................................................................................................................................. 5

10 Reprocessing ....................................................................................................................................................... 5

10.1 Products supplied sterile .................................................................................................................................. 5

10.2 Products provided non-sterile ......................................................................................................................... 5

10.3 Reprocessing information ................................................................................................................................ 5

11 Information to be supplied by the manufacturer ........................................................................................ 5

11.1 General ................................................................................................................................................................... 5

11.2 Marking on instruments ..................................................................................................................................... 5

11.3 Labelling on the package .................................................................................................................................. 6

11.4 Instructions for use ............................................................................................................................................. 6

Annex A (normative) Materials found acceptable for instrument manufacture................................................. 7

Annex B (informative) Cross-referencing of steel grades specified in international, regional or

national standards ............................................................................................................................................13

Bibliography .....................................................................................................................................................................15

© ISO 2012 – All rights reserved iii
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SIST EN ISO 13504:2012
ISO 13504:2012(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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

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.

ISO 13504 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.

iv © ISO 2012 – All rights reserved
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SIST EN ISO 13504:2012
ISO 13504:2012(E)
Introduction

The use of dental implants is increasing throughout the world. Due to improved and new applications of dental

implants, the need for better instruments and related accessories to be used in the placement of dental implants

and the further manipulation of connecting parts in the craniofacial area is also growing. Dental implants need

to be approved by local authorities.

However, instruments used in the placement of dental implants are different and need a different approval

procedure. This International Standard is intended to harmonize the approval procedures and to reduce the

costs caused by repeated approval and test procedures in different countries.

Materials present in instruments used in dental implant procedures have proven to be well tolerated. Potential

adverse reactions cannot be totally ruled out but such reactions are to be mitigated.

However, long-term clinical experience of the use of the materials referred to in this International Standard

has shown that an acceptable level of biological response can be expected when they are used in appropriate

applications and when instruments are manufactured under appropriate design considerations and processes.

Due to different stainless steel standards, Annex B has been added. This gives cross-references to designations

of stainless steels which are listed in other international, regional or national standards designation systems.

© ISO 2012 – All rights reserved v
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SIST EN ISO 13504:2012
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SIST EN ISO 13504:2012
INTERNATIONAL STANDARD ISO 13504:2012(E)
Dentistry — General requirements for instruments and related
accessories used in dental implant placement and treatment
1 Scope

This International Standard specifies general requirements for the manufacture of instruments and related

accessories used in the placement of dental implants and further manipulations of connecting parts in the

craniofacial area.

It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or

connected to a power-driven system.

It is not applicable to the power-driven system itself, nor to the dental implant or to parts intended to be

connected to the dental implant.

With regard to safety, this International Standard gives requirements for classification, intended performance,

performance attributes, material selection, performance evaluation, manufacture, sterilization and information

to be supplied by the manufacturer.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are indispensable

for its application. For dated references, only the edition cited applies. For undated references, the latest edition

of the referenced document (including any amendments) applies.

ISO 1043-1, Plastics — Symbols and abbreviated terms — Part 1: Basic polymers and their special characteristics

ISO 1942, Dentistry — Vocabulary

ISO 2768-1, General tolerances — Part 1: Tolerances for linear and angular dimensions without individual

tolerance indications

ISO 5832-2, Implants for surgery — Metallic materials — Part 2: Unalloyed titanium

ISO 5832-3, Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy

ISO 7405, Dentistry — Evaluation of biocompatibility of medical devices used in dentistry

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process

ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development,

validation and routine control of a sterilization process for medical devices

ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,

validation and routine control of a sterilization process for medical devices

ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice

ISO 14971, Medical devices — Application of risk management to medical devices

ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to

be supplied — Part 1: General requirements

ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the processing

of resterilizable medical devices
© ISO 2012 – All rights reserved 1
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SIST EN ISO 13504:2012
ISO 13504:2012(E)

ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,

validation and routine control of a sterilization process for medical devices
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.

3.1
transient usage
usage for less than 60 min in any one clinical procedure
3.2 Instruments
3.2.1
surgically invasive device

device which penetrates into the human body through the surface of the body, with the aid or in the context of

a surgical operation
3.2.2
instrument used in dental implant placement and treatment

surgically invasive device, used with a transient usage for the preparation of bone and tissue in the craniofacial

region, to be used in the placement of dental implants and the further manipulation of connecting parts

3.2.3
accessory used in dental implant placement and treatment

non-surgically invasive device, used with a transient usage in direct or indirect contact with the human body, to

be used in the placement of dental implants and the further manipulation of connecting parts

3.3 Stainless steel
3.3.1
stainless steel

steel, the main alloying element of which is chromium, of at least 10,5 % (mass fraction) Cr and maximum 1,2 %

(mass fraction) C, and the primary importance of which is its resistance to corrosion

3.3.2
austenitic stainless steel

corrosion-resistant steel, typically with composition of less than 0,2 % (mass fraction) C, at least 16% (mass

fraction) Cr, typically about 18 % (mass fraction) Cr and over 8 % (mass fraction) Ni, which cannot be hardened

by heat treatment
3.3.3
martensitic stainless steel

corrosion-resistant steel with low to medium carbon, with at least 0,1 % (mass fraction) C and between 12 %

(mass fraction) and 19 % (mass fraction) Cr, which can be hardened by quenching and tempering

3.3.4
precipitation-hardening stainless steel

corrosion-resistant steel with a high strength resulting from the precipitation of intermetallic compounds (the

formation of very fine intermetallic phases, carbides and Laves phases in the structure) by a final heat treatment

at relatively low temperature
2 © ISO 2012 – All rights reserved
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SIST EN ISO 13504:2012
ISO 13504:2012(E)
4 Classification
4.1 Intended usage (application)

For the purposes of this International Standard, instruments used in dental implant placement and treatment

are classified as follows, according to their intended usage (application), as stated by the manufacturer.

— Type 1: energized or motor driven instruments.
— Type 2: instruments for manual use (hand instruments).
...

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