SIST EN 12182:2012
(Main)Assistive products for persons with disability - General requirements and test methods
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.
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
Relations
Standards Content (Sample)
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 . 135.2.2Upholstered parts, mattresses, bed bases and bedding . 135.2.3Upholstered parts . 135.2.4Mattresses and bed bases . 135.2.5Bedding . 145.2.6Moulded parts . 145.3Biocompatibility and toxicity . 145.4Contaminants and residues . 145.4.1General . 145.4.2Substances which may leak from an assistive product in intended use and in fault conditions . 145.5Infection and microbiological contamination . 155.5.1Cleaning and disinfection . 155.5.2Animal tissue . 155.6Resistance to corrosion . 156Emitted sound and vibration . 156.1Noise and vibration. 156.2Sound levels and frequencies of audible warning devices . 156.3Feedback . 167Electromagnetic compatibility . 167.1General . 167.2Emissions . 167.3Immunity . 167.4Power frequency magnetic field immunity . 168Electrical safety. 178.1General . 178.2Electrical systems. 178.3Continuity of power supply . 178.4Battery powered assistive products . 188.4.1Battery housings. 188.4.2Connection . 188.4.3Charge level indicator . 188.5Circuit protection . 198.6Electronic programmable systems . 208.7Electrically heated blankets, pads and similar flexible heating appliances . 20SIST EN 12182:2012
EN 12182:2012 (E) 3 8.8Assistive products with skin contact electrodes . 208.9Ingress of liquids . 209Overflow, spillage, leakage, and ingress of liquids . 219.1Overflow . 219.1.1Requirements . 219.1.2Test method . 219.2Spillage . 219.2.1Requirements . 219.2.2Test method . 219.3Leakage . 219.4Ingress of liquids . 219.4.1Requirements . 219.4.2Test method . 2210Surface temperature . 2211Sterility. 2211.1Sterility requirements . 2211.2Sterilization processes . 2211.3Maintenance of sterility in transit . 2312Safety of moving parts . 2312.1Squeezing . 2312.2Mechanical wear . 2312.3Emergency stopping functions . 2413Prevention of traps for parts of the human body . 2413.1Holes and clearances . 2413.2V-shaped openings . 2514Folding and adjusting mechanisms . 2514.1General . 2514.2Locking mechanisms . 2514.3Guards . 2515Carrying handles . 2515.1General . 2515.2Requirement . 2615.3Test method . 2616Assistive products which support or suspend users . 2616.1General . 2616.2Static forces . 2716.3Dynamic forces . 2716.4Requirements and test method for tips . 2716.4.1General . 2716.4.2Friction of tips . 2716.4.3Durability of tips . 2717Portable and mobile assistive products . 2718Surfaces, corners, edges and protruding parts . 2919Hand held assistive products. 2920Small parts . 2921Stability . 2922Forces in soft tissues of the human body . 2923Ergonomic principles . 2924Requirements for information supplied by the manufacturer . 3024.1General . 3024.2Instructions for use . 3124.2.1Pre-sale information . 3124.2.2User information . 31SIST EN 12182:2012
EN 12182:2012 (E) 4 24.2.3Service information . 3224.3Labelling . 3225Packaging . 3326Test report . 33Annex A (informative)
European standards for assistive products for persons with a disability produced or currently being developed by CEN/TC 293 . 34Annex B (informative)
General recommendations . 36Annex C (informative)
Cognitive impairment . 43Annex D (informative)
Environmental and consumer related requirements. 50Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices . 56Bibliography . 61 SIST EN 12182:2012
EN 12182:2012 (E) 5 Foreword This document (EN 12182:2012) has been prepared by Technical Committee CEN/TC 293 “Assistive products for persons with a 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 November 2012, and conflicting national standards shall be withdrawn at the latest by November 2012. 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. This document supersedes EN 12182:1999. 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. This standard provides one means to demonstrate that assistive products for persons with a a disability, which are also medical devices, conform to the essential requirements outlined in general terms in Annex I of the EU Directive 93/42/EEC. It is not intended to provide a means to show conformity with the requirements of any other directive.
There are three levels of European Standards dealing with assistive products for persons with a disability. These are as follows, with Level 1 being the highest:
Level 1: General requirements for assistive products; Level 2: Particular requirements for families of assistive products; Level 3: Specific requirements for types of assistive products. Levels 2 and 3 may be combined into one single document.
All European Standards produced or currently being developed by CEN/TC 293 are listed in Annex A.
This standard is a Level 1 standard and contains requirements and recommendations which are generally applicable to assistive products for persons with a disability. For certain types of assistive products, these requirements are to be supplemented, modified or replaced by the special requirements of a standard for a particular assistive product (Level 2 or 3).
The Level 2 standards apply to a more restricted set or family of assistive products such as assistive products for walking. The Level 3 standards apply to specific types of assistive products, e.g. elbow crutches and urine collection bags.
Where standards for particular assistive products or groups of assistive products exist (Level 2 or 3), this general standard should not be used alone. The requirements of lower level standards take precedence over higher level standards. Therefore, to address all requirements for a particular assistive product, it is necessary to start with standards of the lowest available level.
European and International Standards for other assistive products for persons with a disability are being or may be developed by other technical committees within CEN/CENELEC, ISO/IEC (e.g. assistive products for hearing) and other organisations. For such assistive products, this Level 1 standard is only applicable if explicitly cited as a normative reference in the particular standard, although it may be used for general guidance within the field of assistive products for persons with a disability.
SIST EN 12182:2012
EN 12182:2012 (E) 6 NOTE 1 Special care is required in applying this general standard to assistive products for which no particular standard exists to ensure that all aspects of safety are covered in the particular circumstances of the use of those assistive products. Guidance is given on aspects of the Essential Requirements of EU Directive 93/42/EEC to assist in this process. NOTE 2 The use of assistive products may involve undesirable side effects and it is necessary to establish a balance between achieving the desired end result and the risk of such side effects. Hence, in exceptional circumstances, provision is made within this standard for clinical needs to override the requirements of this standard so long as adequate warnings are given. NOTE 3 This standard calls for technical documentation to be prepared which may be used by manufacturers as part of the technical documentation required by EU Directive 93/42/EEC. NOTE 4 Where this standard does not fully apply to particular assistive products, contracting parties should consider if appropriate parts of the standard can be used.
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, Turkey and the United Kingdom. SIST EN 12182:2012
EN 12182:2012 (E) 7 1 Scope
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. 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. EN 556-1, Sterilization of medical devices Requirements for medical devices to be designated "STERILE" Part 1: Requirements for terminally sterilized medical devices EN 597-1, Furniture Assessment of the ignitability of mattresses and upholstered bed bases Part 1: Ignition source: Smouldering cigarette EN 597-2, Furniture Assessment of the ignitability of mattresses and upholstered bed bases Part 2: Ignition source: Match flame equivalent EN 614-1, Safety of machinery Ergonomic design principles Part 1: Terminology and general principles EN 980, Symbols for use in the labelling of medical devices EN 1021-1, Furniture Assessment of the ignitability of upholstered furniture Part 1: Ignition source smouldering cigarette EN 1021-2, Furniture Assessment of the ignitability of upholstered furniture Part 2: Ignition source match flame equivalent EN 1041, Information supplied by the manufacturer of medical devices EN ISO 25424, Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424) EN 60065, Audio, video and similar electronic apparatus Safety requirements (IEC 60065) EN 60335-1, Household and similar electrical appliances Safety Part 1: General requirements (IEC 60335-1) EN 60529, Degrees of protection provided by enclosures (IP Code) (IEC 60529) EN 60601-1:2006, Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005) SIST EN 12182:2012
EN 12182:2012 (E) 8 EN 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests (IEC 60601-1-2:2007, modified) EN 60695-11-10, Fire hazard testing Part 11-10: Test flames 50 W horizontal and vertical flame test methods (IEC 60695-11-10) EN 60730-1, Automatic electrical controls for household and similar use Part 1: General requirements (IEC 60730-1) EN 60950-1, Information technology equipment Safety Part 1: General requirements (IEC 60950-1) EN 61000-3-2, Electromagnetic compatibility (EMC) Part 3-2: Limits Limits for harmonic current emissions (equipment input current ≤ 16 A per phase) (IEC 61000-3-2) EN 61000-3-3, Electromagnetic compatibility (EMC) Part 3-3: Limits Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤16 A per phase and not subject to conditional connection (IEC 61000-3-3) EN 61000-4-3, Electromagnetic compatibility (EMC) Part 4-3: Testing and measurement techniques Radiated, radio-frequency, electromagnetic field immunity test (IEC 61000-4-3) EN 61000-4-8, Electromagnetic compatibility (EMC) Part 4-8: Testing and measurement techniques Power frequency magnetic field immunity test (IEC 61000-4-8) EN 62304, Medical device software Software life-cycle processes (IEC 62304) EN 80601-2-35, Medical electrical equipment Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use (IEC 80601-2-35) EN ISO 3746, Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746) EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1) EN 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 11135-1) EN 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 11137-1) EN ISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose (ISO 11137-2) EN ISO 11607-1, Packaging for termin
...
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 . 22
13 Prevention of traps for parts of the human body . 24
14 Folding and adjusting mechanisms . 25
15 Carrying handles. 25
16 Assistive products which support or suspend users . 27
17 Portable and mobile assistive products . 28
18 Surfaces, corners, edges and protruding parts . 30
19 Hand held assistive products . 30
20 Small parts . 30
21 Stability . 30
22 Forces in soft tissues of the human body . 30
23 Ergonomic principles . 31
24 Requirements for information supplied by the manufacturer . 31
25 Packaging . 33
26 Test report . 34
Annex A (informative) European standards for assistive products for persons with disability
produced or currently being developed by CEN/TC 293 . 35
Annex B (informative) General recommendations . 37
Annex C (normative) Ergonomics and cognition . 43
Annex D (informative) Environmental and consumer related requirements. 44
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical Devices . 65
Bibliography . 69
2
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oSIST prEN 12182:2009
prEN 12182:2009 (E)
Foreword
This document (prEN 12182:2009) has been prepared by Technical Committee CEN/TC 293 “Assistive
products for persons with disability”, the secretariat of which is held by SIS.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 12182:1999.
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 EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document.
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 <>, and conflicting standards shall be withdrawn at the latest by <>.
This standard provides one means to demonstrate that assistive products for persons with disability, which are
also medical devices, conform to the essential requirements outlined in general terms in Annex 1 of the EU
Directive 93/42/EEC, as amended by Directive 2007/47/EC. It is not intended to provide a means to show
conformity with the requirements of any other directive.
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
There are three levels of European Standards dealing with assistive products for persons with disability.
These are as follows, with level 1 being the highest:
Level 1:General requirements for assistive products
Level 2:Particular requirements for families of assistive products
Level 3:Specific requirements for types of assistive products.
Level 2 and 3 may be combined into one single document.
All European Standards produced or currently being developed by CEN/TC 293 are listed in Annex A.
This standard is a level 1 standard and contains requirements and recommendations which are generally
applicable to assistive products for persons with disability. For certain types of assistive products, these
requirements are to be supplemented, modified or replaced by the special requirements of a standard for a
particular assistive product (level 2 or 3).
The level 2 standards apply to a more restricted set or family of assistive products such as assistive products
for walking. The level 3 standards apply to specific types of assistive products, e.g. elbow crutches and urine
collection bags.
Where standards for particular assistive products or groups of assistive products exist (level 2 or 3), this
general standard should not be used alone. The requirements of lower level standards take precedence over
higher level standards. Therefore, to address all requirements for a particular assistive product, it is necessary
to start with standards of the lowest available level.
European and International Standards for other assistive products for persons with disability are being or may
be developed by other technical committees within CEN/CENELEC, ISO/IEC (e.g. assistive products for
hearing) and other organizations. For such assistive products, this level 1 standard is only applicable if
explicitly cited as a normative reference in the particular standard, although it may be used for general
guidance within the field of assistive products for persons with disability.
3
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oSIST prEN 12182:2009
prEN 12182:2009 (E)
NOTE 1 Special care is required in applying this general standard to assistive products for which no particular standard
exists to ensure that all aspects of safety are covered in the particular circumstances of the use of those assistive products.
Guidance is given on aspects of the Essential Requirements of EU Directive 93/42/EEC, as amended by Directive
2007/47/EC to assist in this process.
NOTE 2 The use of assistive products may involve undesirable side effects and it is necessary to establish a balance
between achieving the desired end result and the risk of such side effects. Hence, in exceptional circumstances, provision
is made within this standard for clinical needs to override the requirements of this standard so long as adequate warnings
are given.
NOTE 3 This standard calls for technical documentation to be prepared which may be used by manufacturers as part
of the technical documentation required by EU Directive 93/42/EEC, as amended by 2007/47/EC.
NOTE 4 Where this standard does not fully apply to particular assistive products, contracting parties should consider if
appropriate parts of the standard can be used.
4
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oSIST prEN 12182:2009
prEN 12182:2009 (E)
1 Scope
This European Standard specifies general requirements and test methods for assistive products for persons
with disabilities, which are intended by the manufacturer to be medical devices for the purposes of EU
Directive 93/42/EEC, as amended by 2007/47/EC.
This 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 those 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, as amended by 2007/47/EC.
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.
EN 556-1, Sterilization of medical devices – Requirements for medical devices to be designated "STERILE" –
Part 1: Requirements for terminally sterilized medical devices
EN 597-1, Furniture – Assessment of the ignitability of mattresses and bed bases – Part 1: Ignition source:
Smouldering cigarette
EN 597-2, Furniture – Assessment of the ignitability of mattresses and bed bases – Part 2: Ignition source:
Match flame equivalent
EN 614-1, Safety of machinery – Ergonomic design principles – Part 1: Terminology and general principles
EN 716-2, Furniture – Children’s cots and folding cots for domestic use – Part 2: Test methods
EN 1021-1, Furniture – Assessment of the ignitability of upholstered furniture – Part 1: Ignition source:
smouldering cigarette
EN 1021-2, Furniture – Assessment of the ignitability of upholstered furniture – Part 2: Ignition source: match
flame equivalent
EN 1041, Information supplied by the manufacturer with medical devices
EN ISO 3746, Acoustics – Determination of sound power levels of noise sources using sound pressure –
Survey method using an enveloping measurement surface over a reflecting plane
EN ISO 9999, Assistive products for persons with disability – Classification and terminology
EN ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing
EN 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
5
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oSIST prEN 12182:2009
prEN 12182:2009 (E)
EN 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
EN ISO 11137-2, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
EN ISO 12952-1, Textiles – Burning behaviour of bedding items – Part 1: General test methods for the
ignitability by a smouldering cigarette
EN ISO 12952-2, Textiles – Burning behaviour of bedding items – Part 2: Specific test methods for the
ignitability by a smouldering cigarette
EN ISO 12952-3, Textiles – Burning behaviour of bedding items – Part 3: General test methods for the
ignitability by a small open flame
EN ISO 12952-4, Textiles – Burning behaviour of bedding items – Part 4: Specific test methods for the
ignitability by a small open flame
EN ISO 13732-1, Ergonomics of the thermal environment – Methods for the assessment of human responses
to contact with surfaces – Part 1: Hot surfaces
EN ISO 13850, Safety of machinery – Emergency stop – Principles for design
EN ISO 14155-1:2003, Clinical investigation of medical devices for human subjects – Part 1: General
requirements
EN ISO 14155-2:2003, Clinical investigation of medical devices for human subjects – Part 2: Clinical
investigation plans
EN ISO 14971, Medical devices – Application of risk management to medical devices
EN 15424, Sterilization of medical devices – Low temperature steam and formaldehyde – Requirements for
development, validation and routine control of a sterilization process for medical devices
EN ISO 22442-1, Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk
management
1)
FprEN ISO 24415-1– , Tips for assistive products for walking – Requirements and test methods – Part 1:
Friction of tips
2)
ISO DIS 24415-2– , Durability of tips for crutches
EN 60065, Audio, video and similar electronic apparatus – Safety requirements
EN 60335-1, Household and similar electrical appliances – Safety – Part 1: General requirements
EN 60529, Degrees of protection provided by enclosures (IP Code)
EN 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance
EN 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
1) To be published.
2) To be published.
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EN 60601-2-35, Medical electrical equipment - Particular requirements for the safety of blankets, pads and
mattresses, intended for heating in medical use
EN 60695-11-10, Fire hazard testing – Part 11-10: Test flames – 50 W horizontal and vertical flame test
methods
EN 60950-1, Information technology equipment – Safety – Part 1: General requirements
EN 61000-3-2, Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions
(equipment input current ≤ 16 A per phase)
EN 61000-3-3, Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage
fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤16 A per phase
and not subject to conditional connection
EN 61000-4-3, Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques -
Radiated, radio-frequency, electromagnetic field immunity test
EN 61000-4-8, Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques – Power
frequency magnetic field immunity test
EN 62304, Medical device software -- Software life-cycle processes
IEC 60730-1, Automatic electrical controls for household and similar use – Part 1: General requirements
CISPR 11, Industrial, scientific and medical (ISM) radio-frequency equipment - Electromagnetic disturbance
characteristics - Limits and methods of measurement
NOTE Standards which are referred to in the text as informative material are listed in Bibliography.
3 Terms and definitions
For the purposes of this European Standard, the following terms and definitions apply.
3.1
assistant
person who is helping a person with disability in using the assistive product
NOTE Examples of the ways in which assistants helps persons with disabilities are: Pushing wheelchairs, operating
hoists, assisting with entering and leaving seats, beds and wheelchairs.
3.2
assistive product(s)
instrument, equipment or technical system intended by the manufacturer to be used for the prevention,
treatment or alleviation of, or compensation for injury, impairment, disability or handicap of a person with
disability
NOTE The definition is not identical with the definition in EN ISO 9999 because EN 12182 is restricted to medical
devices.
3.3
bedding
items normally placed on a mattress
NOTE Bedding includes: Mattress covers, underlays, incontinence sheets and pads, sheets, blankets, electric
blankets, quilts (duvets) and their covers, pillows and bolsters, pillow cases.
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3.4
class I
term referring to electrical equipment in which protection against electric shock does not rely on basic
insulation only, but which includes an additional safety precaution in that means are provided for accessible
parts of metal or internal parts of metal to be protectively earthed
3.5
class II
term referring to electrical equipment in which protection against electric shock does not rely on basic
insulation only, but in which additional safety precautions such as double insulation or reinforced insulation are
provided, there being no provision for protective earthing or reliance upon installation conditions
3.6
clinical evaluation
means for confirming that an assistive product conforms to the requirements of EU Directive 93/42/EEC as
amended by 2007/47/EC when used as intended by the manufacturer.
NOTE It may include a compilation of clinical data, any scientific literature and the results of any clinical
investigations, taking into account any relevant harmonized standards.
3.7
clinical investigation
any systematic study in human subjects, undertaken to verify the safety and performance of a specific medical
device, under the manufacturer’s intended conditions of use
3.8
disability
umbrella term for impairments, activity limitations and participation restrictions denoting the negative aspects
of the interaction between an individual (with a health condition) and that individual's contextual factors
(environmental and personal factors)
3.9
hand held assistive products
equipment intended to be supported by the hand during normal use
3.10
impairments
problems in body function or structure, such as a significant deviation or loss
3.11
intended use
use of a product, process or service in accordance with the specifications, instructions and information
provided by the manufacturer
3.12
maximum rated load
greatest permissible load as specified by the manufacturer
NOTE Includes user mass and the mass and loading of the accessories (mattresses, baskets etc.).
3.13
medical electrical system
combination, as specified by its manufacturer, of items of equipment, at least one of which is a medical
equipment to be inter-connected by functional connection or by use of a multiple socket-outlet
3.14
mobile assistive products
equipment intended to be moved from one location to another while supported by its own wheels or equivalent
means
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3.15
normal use
operation. including routine inspection and adjustments by any operator, and stand-by, according to the
instructions for use
NOTE Normal use is not to be confused with intended use. While both include the concept of use as intended by the
manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical purposes,
but maintenance, service, transport, etc. as well.
3.16
operator
person handling the assistive product
NOTE The operator can either be the user or the assistant.
3.17
person with disability
person with one or more impairments, one or more activity limitations, one or more participation restrictions or
a combination thereof
3.18
portable assistive products
equipment intended to be moved from one location to another while being carried by one or more persons
3.19
single fault condition
condition in which a single means for reducing a risk is defective or a single abnormal condition is present
3.20
technical documentation
manufacturer’s data that shows that an assistive product conforms to the requirements of this standard and
which may be used as part of the technical documentation required by EU Directive 93/42/EEC as amended
by 2007/47/EC for conformity assessment procedures
3.21
user
person with a disability for whom the assistive product is intended
4 General requirements
4.1 Risk management
The safety of an assistive product shall be assessed by identifying hazards and estimating the risks
associated with them using the procedure specified in EN ISO 14971.
NOTE 1 In the case of certain disabilities there may be a need for higher levels of safety for equipment used to offset
the effects of that disability.
NOTE 2 Conformity with the requirements of this standard may be used to claim compliance with the requirements of
EN ISO 14971 for those hazards and risks identified in this standard.
NOTE 3 When using an assistive product in combination with a device that is not a medical device the device shall
behave in a safe way regarding the MDD as a system.
4.2 Intended performance and technical documentation
a) An assistive product shall have sufficient strength and durability to sustain all loads expected during
intended use. This shall be confirmed by using, as appropriate, references to relevant clinical and
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scientific literature in addition to requirements in this standard, strength and/or durability calculations,
appropriate test standards and their test results.
b) The intended performance including, if appropriate, strength, durability and tipping stability of an assistive
product shall be described in technical documentation which sets out its functional characteristics, its
application(s) and conditions of use.
c) The technical documentation shall include, if appropriate, references to relevant clinical and scientific
literature, any strength and/or life calculations, conformity with appropriate test standards and their test
results.
4.3 Clinical evaluation and investigation
A clinical evaluation shall be done for all assistive products.
If, as part of the product conformity assessment, the clinical evaluation requires a clinical investigation, the
clinical investigation shall conform to the requirements of EN ISO 14155-1:2003 and EN ISO 14155-2:2003. A
clinical evaluation shall always be done before performing a clinical investigation. Evaluation of clinical data
should be done using MEDDEV 2.7.1
4.4 Assistive products that can be dismantled
If it is intended that an assistive product can be dismantled for storage or transportation, it shall not be
possible to reassemble the assistive product in a manner that presents a hazard.
4.5 Fasteners
If it is intended that an assistive product can be dismantled for storage or transportation, the fasteners which
are loosened or removed to allow this dismantling shall not be single use fasteners.
EXAMPLE Single use fasteners include wood screws and self-tapping screws.
4.6 Mass limits
The user mass limit and maximum rated load shall be declared by the manufacturer.
4.7 Immobilising means
If the movement of an asisitive product or of any of its parts costitutes a risk for the user or a nearby person,
there shall be immobilising means that provide control of the speed and/or prevent any un-desired movement.
5 Materials
5.1 General
Manufacturers should, wherever possible, use materials that can be recycled for further use.
For guidance see EN 60601-1-9, Medical electrical equipment – Part 1-9: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for environmentally conscious for
guidance.
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5.2 Flammability
5.2.1 General
Manufacturers shall consider the environments and methods of use to which an assistive product or any
materials that are usually used in combination with this assistive product, will be exposed and take appropriate
steps to minimize any fire hazard.
The manufacturer shall include a warning in the user instruction about safe combinations of flame resistant
and non flame resistant materials.
If an assistive product is not flame resistant, the manufacturer's information shall describe the precautions
necessary to ensure the safety of the user and/or assistant and the assistive product shall be labelled to show
that it is not flame resistant.
Every effort should be made to use products which meet the flammability requirements as it is of particular
importance to persons with disabilities who may not be able to escape from a fire. The use of non-flame
retardant materials should be reviewed regularly as there is continuous development in this field.
Special attention shall be paid to assistive products were the main purpose is protection from fire.
NOTE For guidance see Annex B, B.5.2.
5.2.2 Upholstered parts, mattresses, bed bases and bedding
Upholstered parts, mattresses and bed bases and bedding shall comply with the requirements of 5.2.2 a) or
5.2.2 b).
a) if the manufacturer claims that an assistive product is resistant to smoker´s materials it shall comply with
the appropriate requirements in
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