SIST EN 12182:2012

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

• Status: Withdrawn
• Public Enquiry End Date: 14-Oct-2009
• Publication Date: 01-Aug-2012
• Withdrawal Date: 15-Aug-2022
• ICS: 11.180.01 - Aids for disabled and handicapped persons in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 04-Aug-2022
• Due Date: 27-Aug-2022
• Completion Date: 16-Aug-2022
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 12182:2012 - Assistive products for persons with disability - General requirements and test methods

Relations

• Replaced By: SIST EN ISO 21856:2022 - Assistive products - General requirements and test methods (ISO 21856:2022)
• Effective Date: 01-Sep-2022
• Replaces: SIST EN 12182:2000 - Technical aids for disabled persons - General requirements and test methods
• Effective Date: 01-Sep-2012

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

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