1、July 2012 Translation by DIN-Sprachendienst.English price group 23No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 1
2、1.180.01!$=x“1902685www.din.deDDIN EN 12182Assistive products for persons with disability General requirements and test methods;English version EN 12182:2012,English translation of DIN EN 12182:2012-07Technische Hilfen fr behinderte Menschen Allgemeine Anforderungen und Prfverfahren;Englische Fassun
3、g EN 12182:2012,Englische bersetzung von DIN EN 12182:2012-07Produits dassistance pour personnes en situation de handicap Exigences gnrales et mthodes dessai;Version anglaise EN 12182:2012,Traduction anglaise de DIN EN 12182:2012-07SupersedesDIN EN 12182:1999-11www.beuth.deDocument comprises pagesIn
4、 case of doubt, the German-language original shall be considered authoritative.6406.12 DIN EN 12182:2012-07 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee CEN/TC 293 “Assistive products for persons with a disability” (Secretariat: SI
5、S, Sweden). The responsible German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Working Committee NA 063-01-06 AA Rollsthle. Amendments This standard differs from DIN EN 12182:1999-11 as follows: a) the st
6、andard has been updated and brought in line with the current state of the art; b) Annex B (informative) “General recommendations” has been included; c) Annex C (informative) “Cognitive impairment” has been included; d) Annex D (informative) “Environmental and consumer related requirements” has been
7、included; e) Annex ZA (informative) “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices” has been included. Previous editions DIN 12182: 1999-11 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12182 May 2012 ICS 11.180.01 Supe
8、rsedes EN 12182:1999English Version Assistive products for persons with disability - General requirements and test methods Produits dassistance pour personnes en situation de handicap - Exigences gnrales et mthodes dessai Technische Hilfen fr behinderte Menschen - Allgemeine Anforderungen und Prfver
9、fahren 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
10、 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
11、 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, Hungar
12、y, 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 COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management
13、 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: EEN 12182:2012 (E) 2 Contents Page Foreword 51 Scope 72 Normative references 73 Terms and definitions .94 General requireme
14、nts . 114.1 Risk analysis . 114.2 Intended performance and technical documentation . 114.3 Clinical evaluation and investigation 124.4 Assistive products that can be dismantled . 124.5 Fasteners . 124.6 Mass limits . 124.7 Immobilising means . 124.8 Design requirements in relation to persons with co
15、gnitive impairment. 125 Materials 135.1 General . 135.2 Flammability 135.2.1 General . 135.2.2 Upholstered parts, mattresses, bed bases and bedding 135.2.3 Upholstered parts . 135.2.4 Mattresses and bed bases . 135.2.5 Bedding 145.2.6 Moulded parts . 145.3 Biocompatibility and toxicity . 145.4 Conta
16、minants and residues . 145.4.1 General . 145.4.2 Substances which may leak from an assistive product in intended use and in fault conditions 145.5 Infection and microbiological contamination 155.5.1 Cleaning and disinfection 155.5.2 Animal tissue . 155.6 Resistance to corrosion . 156 Emitted sound a
17、nd vibration . 156.1 Noise and vibration. 156.2 Sound levels and frequencies of audible warning devices 156.3 Feedback . 167 Electromagnetic compatibility . 167.1 General . 167.2 Emissions 167.3 Immunity 167.4 Power frequency magnetic field immunity 168 Electrical safety. 178.1 General . 178.2 Elect
18、rical systems. 178.3 Continuity of power supply . 178.4 Battery powered assistive products . 188.4.1 Battery housings. 188.4.2 Connection 188.4.3 Charge level indicator 188.5 Circuit protection 198.6 Electronic programmable systems . 208.7 Electrically heated blankets, pads and similar flexible heat
19、ing appliances . 20DIN EN 12182:2012-07 EN 12182:2012 (E) 3 8.8 Assistive products with skin contact electrodes . 208.9 Ingress of liquids . 209 Overflow, spillage, leakage, and ingress of liquids . 219.1 Overflow . 219.1.1 Requirements . 219.1.2 Test method . 219.2 Spillage . 219.2.1 Requirements .
20、 219.2.2 Test method . 219.3 Leakage 219.4 Ingress of liquids . 219.4.1 Requirements . 219.4.2 Test method . 2210 Surface temperature 2211 Sterility 2211.1 Sterility requirements 2211.2 Sterilization processes . 2211.3 Maintenance of sterility in transit 2312 Safety of moving parts 2312.1 Squeezing
21、. 2312.2 Mechanical wear 2312.3 Emergency stopping functions 2413 Prevention of traps for parts of the human body . 2413.1 Holes and clearances 2413.2 V-shaped openings . 2514 Folding and adjusting mechanisms 2514.1 General . 2514.2 Locking mechanisms 2514.3 Guards 2515 Carrying handles . 2515.1 Gen
22、eral . 2515.2 Requirement . 2615.3 Test method . 2616 Assistive products which support or suspend users . 2616.1 General . 2616.2 Static forces . 2716.3 Dynamic forces 2716.4 Requirements and test method for tips 2716.4.1 General . 2716.4.2 Friction of tips 2716.4.3 Durability of tips 2717 Portable
23、and mobile assistive products . 2718 Surfaces, corners, edges and protruding parts . 2919 Hand held assistive products. 2920 Small parts . 2921 Stability . 2922 Forces in soft tissues of the human body 2923 Ergonomic principles 2924 Requirements for information supplied by the manufacturer 3024.1 Ge
24、neral . 3024.2 Instructions for use . 3124.2.1 Pre-sale information 3124.2.2 User information 31DIN EN 12182:2012-07 EN 12182:2012 (E) 4 24.2.3 Service information 3224.3 Labelling 3225 Packaging 3326 Test report . 33Annex A (informative) European standards for assistive products for persons with a
25、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
26、 the Essential Requirements of EU Directive 93/42/EEC on Medical Devices 56Bibliography . 61DIN EN 12182:2012-07 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
27、 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 poss
28、ibility 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
29、 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 person
30、s 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 S
31、tandards 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 assisti
32、ve 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 produc
33、ts 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 as
34、sistive 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 s
35、hould 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 o
36、ther 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
37、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. DIN EN 12182:2012-07 EN 12182:2012 (E) 6 NOTE 1 Special care is required in applying this general standard to assistive products for whic
38、h 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 product
39、s 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 s
40、o 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,
41、 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
42、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. DIN EN 12182:2012-07 EN 12182:2012 (E)
43、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 achi
44、eve 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
45、 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 r
46、eferences 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) applie
47、s. 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 b
