Assistive products for persons with disability - General requirements and test methods

This European Standard specifies general requirements and test methods for assistive products for persons with a disability, which are medical devices according to the definition laid down in the EU Directive 93/42/EEC.
This European Standard does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user.
Where other European Standards exist for particular types of assistive products then those standards apply. However, some of the requirements of this standard may still apply and may be considered in addition to those in other European standards.
NOTE   Not all the items listed in EN ISO 9999 are medical devices. Contracting parties may wish to consider if this standard or parts of this standard can be used for assistive products which are not medical devices as defined in the EU Directive 93/42/EEC.

Technische Hilfen für behinderte Menschen - Allgemeine Anforderungen und Prüfverfahren

Die vorliegende Europäische Norm legt allgemeine Anforderungen und Prüfverfahren für technische Hilfs-mittel für Menschen mit Behinderung fest, die als Medizinprodukte im Sinne der Festlegungen innerhalb der EU-Richtlinie 93/42/EWG, vorgesehen sind.
Diese Europäische Norm gilt nicht für technische Hilfsmittel, deren vorgesehener Verwendungszweck es ist, dem Benutzer pharmazeutische Substanzen zu verabreichen.
Wenn für bestimmte Arten technischer Hilfsmittel andere Europäische Normen bestehen, dann gelten diese Normen. Einige der Anforderungen der vorliegenden Norm können jedoch weiterhin gültig sein und zusätzlich in diesen anderen Europäischen Normen berücksichtigt werden.
ANMERKUNG   Nicht alle der in EN ISO 9999 aufgeführten Gegenstände sind Medizinprodukte. Vertragspartner können auch erwägen, ob diese Norm oder Teile davon zur Festlegung von Hilfsmitteln, die nicht als Medizinprodukte im Sinne der EU-Richtlinie 93/42/EWG, eingestuft sind, herangezogen werden können.

Produits d'assistance pour personnes en situation de handicap - Exigences générales et méthodes d'essai

La présente Norme européenne spécifie les exigences générales et les méthodes d’essai concernant les produits
d’assistance pour personnes en situation de handicap, qui constituent des dispositifs médicaux conformément à la
définition donnée dans la Directive UE 93/42/CEE.
La présente Norme européenne ne s’applique pas aux produits d’assistance dont l’utilisation prévue est
d’administrer à l’utilisateur des substances pharmacologiques.
Dans les cas où il existe des normes européennes concernant des types particuliers de produits d’assistance, ce
sont ces normes qui s’appliquent. Cependant, certaines exigences de la présente norme peuvent toujours
s’appliquer et être étudiées en plus de celles des autres normes européennes.
NOTE Les articles énumérés dans l’EN ISO 9999 ne sont pas tous des dispositifs médicaux. Il se peut que les parties
contractantes souhaitent considérer si la présente norme, ou des parties de la présente norme, peuvent être utilisées pour
spécifier des produits d’assistance qui ne sont pas des dispositifs médicaux tels que définis dans la Directive UE 93/42/CEE.

Tehnični pripomočki za invalidne osebe - Splošne zahteve in preskusne metode

Ta evropski standard določa splošne zahteve in preskusne metode za tehnične pripomočke za invalidne osebe, ki so medicinski pripomočki v skladu z opredelitvijo iz Direktive 93/42/EGS. Ta evropski standard ne velja za tehnične pripomočke, katerih predvideni namen je dajanje farmacevtskih sredstev uporabniku. Kadar v zvezi s posebnimi vrstami tehničnih pripomočkov obstajajo drugi evropski standardi, se uporabljajo ti. Vendar lahko še vedno veljajo nekatere zahteve iz tega standarda in se upoštevajo poleg zahtev iz drugih evropskih standardov.

General Information

Status
Withdrawn
Publication Date
08-May-2012
Withdrawal Date
19-Jul-2022
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
20-Jul-2022

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Technische Hilfen für behinderte Menschen - Allgemeine Anforderungen und PrüfverfahrenProduits d'assistance pour personnes en situation de handicap - Exigences générales et méthodes d'essaiAssistive products for persons with disability - General requirements and test methods11.180.01VSORãQRAids for disabled and handicapped persons in generalICS:Ta slovenski standard je istoveten z:EN 12182:2012SIST EN 12182:2012en,fr,de01-september-2012SIST EN 12182:2012SLOVENSKI
STANDARDSIST EN 12182:20001DGRPHãþD



SIST EN 12182:2012



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12182
May 2012 ICS 11.180.01 Supersedes EN 12182:1999English Version
Assistive products for persons with disability - General requirements and test methods
Produits d'assistance pour personnes en situation de handicap - Exigences générales et méthodes d'essai
Technische Hilfen für behinderte Menschen - Allgemeine Anforderungen und Prüfverfahren This European Standard was approved by CEN on 9 March 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, 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 worldwide for CEN national Members. Ref. No. EN 12182:2012: ESIST EN 12182:2012



EN 12182:2012 (E) 2 Contents Page Foreword .51Scope .72Normative references .73Terms and definitions .94General requirements . 114.1Risk analysis . 114.2Intended performance and technical documentation . 114.3Clinical evaluation and investigation. 124.4Assistive products that can be dismantled . 124.5Fasteners . 124.6Mass limits . 124.7Immobilising means . 124.8Design requirements in relation to persons with cognitive impairment. 125Materials . 135.1General . 135.2Flammability . 135.2.1General . 135.2.2U
...

SLOVENSKI STANDARD
oSIST prEN 12182:2009
01-september-2009
7HKQLþQLSULSRPRþNL]DLQYDOLGQHRVHEH6SORãQH]DKWHYHLQSUHVNXVQHPHWRGH
Assistive products for persons with disability - General requirements and test methods
Technische Hilfen für behinderte Menschen - Allgemeine Anforderungen und
Prüfverfahren
Produits d'assistance pour personnes en situation de handicap - Exigences générales et
méthodes d'essai
Ta slovenski standard je istoveten z: prEN 12182
ICS:
11.180.01 3ULSRPRþNL]D Aids for disabled and
RQHVSRVREOMHQHLQ handicapped persons in
KHQGLNHSLUDQHRVHEHQD general
VSORãQR
oSIST prEN 12182:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 12182:2009

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oSIST prEN 12182:2009
EUROPEAN STANDARD
DRAFT
prEN 12182
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.180.01 Will supersede EN 12182:1999
English Version
Assistive products for persons with disability - General
requirements and test methods
Produits d'assistance pour personnes en situation de Technische Hilfen für behinderte Menschen - Allgemeine
handicap - Exigences générales et méthodes d'essai Anforderungen und Prüfverfahren
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 293.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, 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.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 12182:2009: E
worldwide for CEN national Members.

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oSIST prEN 12182:2009
prEN 12182:2009 (E)
Contents Page
Foreword .3
1 Scope .5
2 Normative references .5
3 Terms and definitions .7
4 General requirements .9
5 Materials . 10
6 Noise, vibration and sound . 14
7 Electromagnetic compatibility . 15
8 Electrical safety. 16
9 Overflow, spillage, leakage, and ingress of liquids . 20
10 Surface temperature . 21
11 Sterility . 22
12 Safety of moving parts .
...

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