EN ISO 11953:2010

Dentistry - Implants - Clinical performance of hand torque instruments (ISO 11953:2010)

ISO 11953:2010 describes a classification system for hand-held torque wrenches intended for clinical use. It specifies their performance requirements in terms of accuracy and reproducibility and resistance to reprocessing. Test methods are described, and marking and labelling requirements specified.

Zahnheilkunde - Implantate - Klinisches Verhalten manuell angewandter Drehmomentschlüssel (ISO 11953:2010)

Diese Internationale Norm enthält eine Einteilung für manuell angewandte Drehmomentschlüssel, die zur
klinischen Anwendung vorgesehen sind. Sie legt Anforderungen an Genauigkeit und Wiederholgenauigkeit
sowie an Beständigkeit gegenüber einer Wiederaufbereitung fest. Die dazugehörigen Prüfverfahren werden
beschrieben, und Anforderungen an Kennzeichnung und Etikettierung werden festgelegt. Elektronisch
gesteuerte Instrumente sind kein Bestandteil dieser Norm.

Médecine bucco-dentaire - Implants - Performances cliniques des instruments de serrage (ISO 11953:2010)

L'ISO 11953:2010 décrit un système de classification des clés dynamométriques à commande manuelle à usage clinique. Elle spécifie les exigences de performance auxquelles elles sont soumises en termes d'exactitude, de reproductibilité et de résistance au retraitement. Elle décrit les méthodes d'essai et spécifie les exigences de marquage et d'étiquetage. La présente Norme internationale n'inclut pas les dispositifs à commande électronique.

Zobozdravstvo - Implantati - Klinične lastnosti ročnih vrtilnih instrumentov (ISO 11953:2010)

Ta mednarodni standard opisuje sistem razvrščanja za ročne vrtilne vijačnike, namenjene za klinično uporabo. Določa zahteve za njihovo delovanje z vidika natančnosti in ponovljivosti ter odpornosti proti ponovni obdelavi. Opisane so preskusne metode in določene so zahteve za označevanje in uporabo nalepk. Ta mednarodni standard ne vključuje elektronsko krmiljenih pripomočkov.

General Information

• Status: Published
• Publication Date: 31-May-2010
• Withdrawal Date: 30-Dec-2010
• ICS: 11.060.15 - Dental implants
• ICS: 11.060.25 - Dental instruments
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Jun-2010
• Completion Date: 01-Jun-2010
• Ref Project: SIST EN ISO 11953:2010 - Dentistry - Implants - Clinical performance of hand torque instruments (ISO 11953:2010)

Overview - EN ISO 11953:2010 (Dentistry - Implants - Clinical performance of hand torque instruments)

EN ISO 11953:2010 specifies a classification system and performance requirements for hand-held torque instruments (manual torque wrenches) used in dental implant procedures. The standard addresses clinical performance, including accuracy, reproducibility and resistance to reprocessing, and defines required test methods, marking and labelling. Electronically controlled torque devices are excluded.

Key topics and technical requirements

• Scope & classification
  • Defines four device types (Type 1–4) based on mechanical torque-control methods (break/clutch, adjustable break, torque beam, and torque applicator for contra-angle handpieces).
• Performance: accuracy & reproducibility
  • Torque values (break point or indicated torque) must lie within the manufacturer’s stated specification, both initially and after reprocessing.
  • Manufacturers must state the number of usages before recalibration or discard.
• Test methods
  • Describes standardized test rigs, components and procedures for each device type.
  • Key test rig parameters include a downward force on the screwdriver tip of 10 ± 1 N, rotational simulation up to 0.25 s (15 r/min), and a torque-measuring device accuracy of 0.1 N·cm ±5%.
  • Mechanical cycling (tightening/unloading) is performed repeatedly (e.g., 20 cycles) and repeated after reprocessing.
• Reprocessing
  • Reprocessing (cleaning, disinfection, sterilization) must follow the manufacturer’s instructions consistent with ISO 17664; devices must maintain performance after specified reprocessing cycles.
• Marking, labelling and instructions
  • Required information includes lot number, torque range (min/max for adjustable devices), reprocessing instructions, recommended number of usages before recalibration/discard, maintenance requirements, and manufacturer contact details.

Practical applications - who uses EN ISO 11953:2010

• Dental implant manufacturers - design and validate manual torque instruments to meet clinical performance criteria and produce compliant labelling and IFU (instructions for use).
• Regulatory and conformity testing laboratories - perform standardized mechanical and reprocessing tests to verify accuracy and reproducibility.
• Dental clinics and procurement - evaluate and select compliant hand torque instruments and understand recommended usage and maintenance.
• Sterilization & processing teams - ensure reprocessing instructions preserve instrument performance.

Related standards

• ISO 17664 - Sterilization of medical devices: information for reprocessing
• ISO 1942 - Dentistry - Vocabulary
• (Bibliography mentions ISO 6789 and ISO 13402 as related test/requirements references)

Keywords: EN ISO 11953:2010, hand torque instruments, dental implants, torque wrenches, clinical performance, accuracy, reproducibility, reprocessing, test methods, marking and labelling.

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2010
=RER]GUDYVWYR,PSODQWDWL.OLQLþQHODVWQRVWLURþQLKYUWLOQLKLQVWUXPHQWRY,62

Dentistry - Implants - Clinical performance of hand torque instruments (ISO 11953:2010)
Zahnheilkunde - Implantate - Klinisches Verhalten manuell angewandter
Drehmomentschlüssel (ISO 11953:2010)
Médecine bucco-dentaire - Implants - Performances cliniques des instruments de
serrage (ISO 11953:2010)
Ta slovenski standard je istoveten z: EN ISO 11953:2010
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 11953
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2010
ICS 11.060.15
English Version
Dentistry - Implants - Clinical performance of hand torque
instruments (ISO 11953:2010)
Médecine bucco-dentaire - Implants - Performances
cliniques des instruments de serrage (ISO 11953:2010)
This European Standard was approved by CEN on 19 May 2010.

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 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 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11953:2010: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 11953:2010) 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 December 2010, and conflicting national standards shall be withdrawn
at the latest by December 2010.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 11953:2010 has been approved by CEN as a EN ISO 11953:2010 without any modification.

INTERNATIONAL ISO
STANDARD 11953
First edition
2010-06-01
Dentistry — Implants — Clinical
performance of hand torque instruments
Médecine bucco-dentaire — Implants — Performances cliniques des
instruments de serrage
Reference number
ISO 11953:2010(E)
©
ISO 2010
ISO 11953:2010(E)
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ii © ISO 2010 – All rights reserved

ISO 11953:2010(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 11953 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 8, Dental
implants.
ISO 11953:2010(E)
Introduction
Screw-retained joints are used widely in dental implant systems and for their integrity depend on the creation
and maintenance of an appropriate clamping force. Failure of such joints is a documented clinical problem that
can have significant impact on the outcome of treatment. Manually operated, suitably calibrated torque
wrenches or devices are widely employed in dental implant treatment to tighten screwed joints and should be
capable of providing the desired torque in a consistent manner. There is, however, some evidence that this
might not always be the case. This International Standard has, therefore, been developed to facilitate the
availability of devices that meet the necessary clinical requirements and help ensure a successful clinical
outcome.
iv © ISO 2010 – All rights reserved

INTERNATIONAL STANDARD ISO 11953:2010(E)

Dentistry — Implants — Clinical performance of hand torque
instruments
1 Scope
This International Standard describes a classification system for hand-held torque wrenches intended for
clinical use. It specifies their performance requirements in terms of accuracy and reproducibility and
resistance to reprocessing. Test methods are described, and marking and labelling requirements are specified.
This International Standard does not include electronically controlled devices.
2 Normative references
The following referenced documents are indispensable for the application 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 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
3 Terms and definitions
...