EN ISO 22523:2006
(Main)External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
ISO 22523:2006 specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999:
06 03 - 06 15 Orthoses06 18 - 06 27 Limb prostheses
It covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components.
This International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999 and it is not normally body worn.
Externe Gliedmaßenprothesen und externe Orthesen - Anforderungen und Prüfverfahren (ISO 22523:2006)
Diese Internationale Norm legt Anforderungen an und Prüfverfahren für externe Gliedmaßenprothesen und externe Orthesen fest, einschließlich der folgenden Klassifikationen nach EN ISO 9999:
06 03 06 15 Orthesen
06 18 06 27 Gliedmaßenprothesen
Diese Europäische Norm befasst sich mit Festigkeit, Werkstoffen, Einschränkungen im Gebrauch, Risiken und der Bereitstellung von Informationen über den normalen Gebrauch von Einzelbauteilen und Baugruppen.
Diese Internationale Norm befasst sich nicht mit speziellen Sitzschalen, da diese nach ISO 9999 nicht als Orthese klassifiziert sind und normalerweise nicht am Körper getragen werden.
ANMERKUNG 1 Es ist beabsichtigt, zukünftig orthopädisches Schuhwerk (Klassifikation 06 33) einzubeziehen.
ANMERKUNG 2 Die Anwendung von Qualitätssicherungssystemen, wie in ISO 13485 und ISO 13488 beschrieben oder angeführt, kann geeignet sein.
Prothèses de membre externes et orthèses externes - Exigences et méthodes d'essai (ISO 22523:2006)
L'ISO 22523:2006 spécifie les exigences et les méthodes d'essai applicables aux prothèses de membre externes et orthèses externes, y compris les classifications suivantes de l'ISO 9999:
06 03 - 06 15 Orthèses06 18 - 06 27 Prothèses de membre
Elle couvre la résistance, les matériaux utilisés, les restrictions d'utilisation, les risques et les informations associés aux conditions normales d'utilisation des composants et des ensembles de composants.
La présente Norme internationale ne traite pas des «corsets-sièges» car ils ne sont pas classés comme orthèses dans l'ISO 9999 et ne sont pas normalement portés sur le corps.
Proteze zunanjih okončin in zunanje ortoze - Zahteve in preskusne metode (ISO 22523:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2007
1DGRPHãþD
SIST EN 12523:2000
3URWH]H]XQDQMLKRNRQþLQLQ]XQDQMHRUWR]H=DKWHYHLQSUHVNXVQHPHWRGH ,62
External limb prostheses and external orthoses - Requirements and test methods (ISO
22523:2006)
Externe Gliedmaßenprothesen und externe Orthesen - Anforderungen und Prüfverfahren
(ISO 22523:2006)
Protheses de membre externes et ortheses externes - Exigences et méthodes d'essai
(ISO 22523:2006)
Ta slovenski standard je istoveten z: EN ISO 22523:2006
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
11.180.10 3ULSRPRþNLLQSULODJRGLWYH]D Aids and adaptation for
JLEDQMH moving
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 22523
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2006
ICS 11.040.40
English Version
External limb prostheses and external orthoses - Requirements
and test methods (ISO 22523:2006)
Prothèses de membre externes et orthèses externes - Externe Gliedmaßenprothesen und externe Orthesen -
Exigences et méthodes d'essai (ISO 22523:2006) Anforderungen und Prüfverfahren (ISO 22523:2006)
This European Standard was approved by CEN on 13 April 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22523:2006: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 22523:2006) has been prepared by Technical Committee ISO/TC 168
"Prosthetics and orthotics" in collaboration with Technical Committee CEN/TC 293 "Assistive
products for persons with disability", the secretariat of which is held by SIS.
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 2007, and conflicting national standards shall
be withdrawn at the latest by April 2007.
This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, 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.
Endorsement notice
The text of ISO 22523:2006 has been approved by CEN as EN ISO 22523:2006 without any
modifications.
ANNEX ZA
(informative)
Clauses of this European Standard addressing essential requirements
or other provisions of EU Directives.
This European Standard has been prepared under a mandate given to the European Community
and the European Free Trade Association and supports corresponding essential requirements of
EU Directive 93/42/EEC concerning medical devices and EU Directive 99/5/EC on radio equipment
and telecommunications terminal equipment.
WARNING — Other requirements and other EU Directives may be applicable to the
product(s) falling within the scope of this standard.
The clauses of this standard are likely to support requirements of Directive 93/42 EEC concerning
medical devices (see Table ZA.1) and of Directive 99/5/EC on radio equipment and
telecommunications terminal equipment (see Table ZA.2).
Compliance with this standard provides one means of conforming with the corresponding essential
requirements of the Directive concerned and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and EU Directive 93/42/EEC
Corresponding Comments
Clauses/sub-clauses of this
annexes/paragraphs of
European Standard
Directive 93/42/EEC concerning
medical devices — Annex I:
Essential requirements
All 1
All and specifically: 4.1, 5.1, 2 Specifically: risk management,
5.4, 7, 8.2, 8.3, 9, 11.1, 11.2 flammability/toxicity, corrosion/degradation,
EMC, battery-powered devices, surface
temperature, moving parts, connections
All and specifically 4.2 3 Specifically: intended performance
All and specifically 4.2, 4.4 4 Specifically: intended performance,
strength
All and specifically 13, 14 5 Specifically: information, packaging
All and specifically 4.1 6 Specifically: risk management
5.1, 5.2 7.1 Flammability/toxicity,
biocompatibility/contaminants/residues
5.2, 13, 14 7.2 Biocompatibility/contaminants/residues,
information, packaging
5.2.2, 5.4 7.3 Contaminants/residues,
corrosion/degradation
5.2, 5.4, 11.2 7.6 Biocompatibility/contaminants/residues,
corrosion/ degradation, connections
5.2, 5.3 8.1 Biocompatibility/contaminants/residues,
infection and microbiological contamination
14 8.6 Packaging
Table ZA.1 (continued)
Corresponding annexes/paragraphs Comments
Clauses/sub-clauses of this
of Directive 93/42/EEC concerning
European Standard
medical devices — Annex I:
Essential requirements
12.1, 13 9.1 Restrictions on use, information
7, 9, 11.1, 12.2,12.3 9.2 EMC, surface temperature, moving
parts, forces on soft tissues on the
human body, ergonomic principles
5.1, 8.2 , 8.4 9.3 Inflammability/toxicity, battery
powered devices
8.6
11.3.1 Protection against unintended
radiation
8.3 12.1 Electronic programmable systems
8.1, 8.2 12.2 Battery-powered devices
7 12.5 EMC
8 12.6 Electrical safety
11, 12 12.7.1 Design and mechanical requirements
6 Vibration
12.7.2
6 12.7.3 Noise
8.2, 11.2 12.7.4 Battery-powered devices, connections
9 12.7.5 Surface temperature
8.5 12.8.2 Skin contact electrodes stimulate by
means of electrical energy and may
be considered as energy supply in the
sense of ER 12.8
Information
13.1, 13.2 12.9
13 13 Information, packaging
10 13.6. l) Information on sterilization if specific
devices require to be sterilized for
particular applications
4.3 14 Clinical evaluation
Table ZA.2 — Correspondence between this European Standard and EU Directive 99/5/EC
Comments
Clauses/sub-clauses of this Corresponding annexes/paragraphs of
European Standard Directive 99/5/EC concerning radio
equipment and telecommunications
terminal equipment
8.1, 8.2, 8.3, 8.4, 8.7.1 Article 3.1 (a)
Article 3.1 (b)
7, 8.7.1
Article 3.2
8.7.2
8.7.3 Article 3.3 (f)
INTERNATIONAL ISO
STANDARD 22523
First edition
2006-10-01
External limb prostheses and external
orthoses — Requirements and test
methods
Prothèses de membre externes et orthèses externes — Exigences et
méthodes d'essai
Reference number
ISO 22523:2006(E)
©
ISO 2006
ISO 22523:2006(E)
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ISO 22523:2006(E)
Contents Page
Foreword. vi
Introduction . vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 General requirements. 4
4.1 Risk management . 4
4.2 Intended performance and technical documentation. 5
4.3 Clinical evaluation . 5
4.4 Strength and related conditions of use. 5
5 Requirements for materials . 6
5.1 Flammability of materials and toxicity of combustion products . 6
5.2 Biocompatibility, contaminants and residues . 7
5.2.1 General. 7
5.2.2 Contaminants and residues. 7
5.3 Infection and microbiological contamination . 7
5.4 Resistance to corrosion and degradation. 7
6 Noise and vibration. 7
7 Electromagnetic compatibility (EMC) . 8
8 Electrical safety. 8
8.1 Battery-powered prosthetic and orthotic devices. 8
8.1.1 Battery housings and connections. 8
8.1.2 Charge level indicators . 8
8.2 Circuit protection. 9
8.3 Electronic programmable systems. 9
8.4 Electrically heated blankets, pads and similar flexible heating appliances. 9
8.5 Prosthetic and orthotic devices with skin contact electrodes . 9
8.6 Prosthetic and orthotic devices with radio equipment. 9
8.6.1 General. 9
8.6.2 Frequency spectrum of radio equipment.9
8.6.3 Operation of radio equipment by the user . 9
9 Surface temperature. 10
10 Sterility. 10
11 Design requirements .
...
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