EN 12182-2012 en Assistive products for persons with disability - General requirements and test methods《残疾人技术辅助器具 一般要求和试验方法》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 12182:2012Assistive products for persons with disability General r e q u i r e m e n t s a n d t e s t m e t h o d sBS EN 12182:2012 BRITISH STANDARDNational forewordThis B

2、ritish Standard is the UK implementation of EN 12182:2012. Itsupersedes BS EN 12182:1999 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/173, Assistive products for persons with disability.A list of organizations represented on this committee can beo

3、btained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 67489 1ICS 11.180.01Compliance wi

4、th a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2012.Amendments issued since publicationDate Text affectedBS EN 12182:2012EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE N

5、ORM 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 dassistance pour personnes en situation de handicap - Exigences gnrales et mthodes dessai Technische Hilfen fr behinderte Mensch

6、en - Allgemeine Anforderungen und Prfverfahren 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 alterati

7、on. 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

8、 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,

9、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 COMIT EUROPEN DE NORMALISATION E

10、UROPISCHES KOMITEE FR 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: EBS EN 12182:2012EN 12182:2012 (E) 2 Contents Page Foreword 51 Scope 72 Normative r

11、eferences 73 Terms and definitions .94 General requirements . 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 .

12、124.8 Design requirements in relation to persons with cognitive 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 p

13、arts . 145.3 Biocompatibility and toxicity . 145.4 Contaminants 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 tiss

14、ue . 155.6 Resistance to corrosion . 156 Emitted sound and 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 imm

15、unity 168 Electrical safety. 178.1 General . 178.2 Electrical 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 Elec

16、trically heated blankets, pads and similar flexible heating appliances . 20BS EN 12182:2012EN 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 Te

17、st method . 219.2 Spillage . 219.2.1 Requirements . 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 tr

18、ansit 2312 Safety of moving parts 2312.1 Squeezing . 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 mechanis

19、ms 2514.3 Guards 2515 Carrying handles . 2515.1 General . 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

20、 of tips 2716.4.3 Durability of tips 2717 Portable 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

21、 information supplied by the manufacturer 3024.1 General . 3024.2 Instructions for use . 3124.2.1 Pre-sale information 3124.2.2 User information 31BS EN 12182:2012EN 12182:2012 (E) 4 24.2.3 Service information 3224.3 Labelling 3225 Packaging 3326 Test report . 33Annex A (informative) European standa

22、rds 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) R

23、elationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices 56Bibliography . 61BS EN 12182:2012EN 12182:2012 (E) 5 Foreword This document (EN 12182:2012) has been prepared by Technical Committee CEN/TC 293 “Assistive products for persons wit

24、h 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 Nove

25、mber 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 und

26、er 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 demon

27、strate 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 direct

28、ive. 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: S

29、pecific 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

30、 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

31、 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 exis

32、t (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. E

33、uropean 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

34、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. BS EN 12182:2012EN 12182:2012 (E) 6 NOTE 1 Special care is required in applying this general sta

35、ndard 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.

36、 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

37、 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 app

38、ly 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, Belgiu

39、m, 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. BS

40、EN 12182:2012EN 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 t

41、o 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

42、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 Dir

43、ective 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 (i

44、ncluding 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: I

45、gnition 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 us

46、e 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, Inform

47、ation 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 e

48、lectronic 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) BS EN 12182:2012EN 12182:2012 (