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Nederlandse norm
NEN-EN 12182 (en)
Assistive products for persons with disability - General requirements and test methods
Vervangt NEN-EN 12182:1999; NEN-EN 12182:2009 Ontw.
ICS 11.180.01
mei 2012
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NEN-EN 12182
Als Nederlandse norm is aanvaard: - EN 12182:2012,IDT
Normcommissie 303072 "Classificatie en terminologie van hulpmiddelen voor gehandicapten"
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NEN-EN 12182
Nederlands voorwoord
Voor de in deze norm vermelde normatieve verwijzingen bestaan in Nederland de volgende equivalenten: vermelde norm Nederlandse norm titel EN 556-1 NEN-EN 556-1 Sterilisatie van medische hulpmiddelen - Eisen voor
medische hulpmiddelen die als "steriel" moeten worden gemerkt - Deel 1: Eisen voor de eindverpakking van medische hulpmiddelen
EN 597-1 NEN-EN 597-1 Meubelen - Bepaling van de ontvlambaarheid van matrassen en bedbodems - Deel 1: Ontstekingsbron: smeulende sigaret
EN 597-2 NEN-EN 597-2 Meubelen - Bepaling van de ontvlambaarheid van matrassen en beklede bedbodems - Deel 2: Ontstekingsbron: equivalent van de lucifervlam
EN 614-1 NEN-EN 614-1+A1 Veiligheid van machines - Ergonomische ontwerpprincipes - Deel 1: Terminologie en algemene principes
EN 980 NEN-EN 980 Symbolen voor gebruik bij het etiketteren van medische hulpmiddelen
EN 1021-1 NEN-EN 1021-1 Meubelen - Bepaling van de ontvlambaarheid van beklede meubelen - Deel 1: Smeulende sigaret als ontstekingsbron
EN 1021-2 NEN-EN 1021-2 Meubelen - Bepaling van de ontvlambaarheid van beklede meubelen - Deel 2: Equivalent van de lucifervlam als onstekingsbron
EN 1041 NEN-EN 1041 Informatie die door de fabrikant bij medische hulpmiddelen wordt geleverd
EN ISO 25424 NEN-EN-ISO 25424 Sterilisatie van medische hulpmiddelen - Lage temperatuurstoom en formaldehyde - Eisen voor ontwikkeling, validatie en routine controle van een sterilisatieproces voor medische hulpmiddelen
EN 60065 NEN-EN-IEC 60065/A11 Audio-, video- en soortgelijke elektronische toestellen - Veiligheidseisen
EN 60335-1 NEN-EN-IEC 60335-1 Huishoudelijke en soortgelijke elektrische toestellen - Veiligheid - Deel 1: Algemene eisen
EN 60529 NEN 10529 Beschermingsgraden van omhulsels van elektrisch materieel (IP-codering)
EN 60601-1:2006 NEN-EN-IEC 60601-1:2006 Medische elektrische toestellen - Deel 1: Algemene eisen voor basisveiligheid en essentiële prestaties
EN 60601-1-2:2007 NEN-EN-IEC 60601-1-2:2007
Medische elektrische toestellen - Deel 1-2: Algemene eisen voor de veiligheid en essentiële prestatie - Secundaire norm: Elektromagnetische compatibiliteit - Eisen en beproevingen
EN 60695-11-10 NEN-EN-IEC 60695-11-10 Brandbaarheid van elektrotechnische producten - Deel 11-10: Beproevingsvlammen - Beproevingsmethoden voor horizontale en verticale 50 W-vlammen
EN 60730-1 NEN-EN-IEC 60730-1 Automatische elektrische regelaars voor huishoudelijk en soortgelijk gebruik - Deel 1: Algemene eisen
EN 60950-1 NEN-EN-IEC 60950-1 Apparatuur voor informatietechniek - Veiligheid - Deel 1: Algemene eisen
EN 61000-3-2 NEN-EN-IEC 61000-3-2 Elektromagnetische compatibiliteit (EMC) - Deel 3-2: Limietwaarden - Limietwaarden voor de emissie van harmonische stromen (ingangsstroom van de toestellen ≤ 16 A per fase)
EN 61000-3-3 NEN-EN-IEC 61000-3-3 Elektromagnetische compatibiliteit (EMC) - Deel 3-3: Limietwaarden voor spanningswisselingen, spanningsschommelingen en flikkering in openbare laagspanningsnetten voor apparatuur met een ingangsstroom ≤ 16 A per fase en zonder voorwaardelijke aansluiting
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NEN-EN 12182
EN 61000-4-3 NEN-EN-IEC 61000-4-3 Elektromagnetische compatibiliteit (EMC) - Deel 4-3: Beproevingen en meettechnieken - Uitgestraalde, radiofrequente, elektromagnetische velden - Immuniteitsproef
EN 61000-4-8 NEN-EN-IEC 61000-4-8 Elektromagnetische compatibiliteit (EMC) - Deel 4-8: Beproevingen en meettechnieken - Magnetische immuniteitsproef bij netfrequentie
EN 62304 NEN-EN-IEC 62304 Software voor medische hulpmiddelen - Processen in levenscyclus van programmatuur
EN 80601-2-35 NEN-EN-IEC 80601-2-35 Medische elektrische toestellen - Deel 2-35: Speciale eisen voor basisveiligheid en essentiële prestaties van verwarmingstoestellen gebruikt in dekens, kussens en matrassen en bedoeld voor verwarming in medisch gebruik
EN ISO 3746 NEN-EN-ISO 3746 Akoestiek - Bepaling van geluidvermogenniveaus en geluidenergieniveaus van geluidbronnen met behulp van geluiddrukmetingen - Globale methode met behulp van een omhullend meetoppervlak boven een reflecterend oppervlak
EN ISO 10993-1 NEN-EN-ISO 10993-1 Biologische evaluatie van medische hulpmiddelen - Deel 1: Evaluatie en beproeving met binnen risicomanagement proces
EN ISO 11135-1 NEN-EN-ISO 11135-1 Sterilisatie van producten voor de gezondheidszorg - Ethyleenoxide - Deel 1: Eisen voor de ontwikkeling, validatie en routine controle van een sterilisatieproces voor medische hulpmiddelen
EN ISO 11137-1 NEN-EN-ISO 11137-1 Sterilisatie van producten voor de gezondheidszorg - Radiatie - Deel 1: Eisen voor de ontwikkeling, validatie en routine controle van een sterilisatieproces voor medische hulpmiddelen
EN ISO 11137-2 NEN-EN-ISO 11137-2 Sterilisatie van producten voor de gezondheidszorg - Radiatie - Deel 2: Vaststellen van de sterilisatiedosering
EN ISO 11607-1 NEN-EN-ISO 11607-1 Verpakkingsmateriaal ten behoeve van steriele medische hulpmiddelen die gesteriliseerd worden in de verpakking - Deel 1: Materiaaleisen, steriele barriëresystemen en verpakkingssystemen
EN ISO 12952-1 NEN-EN-ISO 12952-1 Textiel - Beoordeling van de ontvlambaareid van beddengoed - Deel 1: Ontstekingsbron: smeulende sigaret
EN ISO 12952-2 NEN-EN-ISO 12952-2 Textiel - Bepaling van de ontvlambaarheid van beddengoed - Deel 2: Equivalent van de lucifervlam als onstekingsbron
EN ISO 13732-1 NEN-EN-ISO 13732-1 Klimaatomstandigheden - Methoden voor het bepalen van menselijke reacties bij het aanraken van oppervlaken - Deel 1: Warme oppervlakken
EN ISO 13850 NEN-EN-ISO 13850 Veiligheid van machines - Noodstop - Ontwerpbeginselen
EN ISO 14155 EN ISO 14155 Klinisch onderzoek van medische hulpmiddelen voor gebruik bij mensen - Goede klinische praktijkrichtlijnen (GCP)
EN ISO 14971 NEN-EN-ISO 14971 Medische hulpmiddelen - Toepassing van risicomanagement voor medische hulpmiddelen (ISO 14971:2007, gecorrigeerde versie 2007-10-01)
EN ISO 22442-1 NEN-EN-ISO 22442-1 Medische hulpmiddelen waarin dierlijke weefsels en daarvan afgeleide producten zijn gebruikt - Deel 1: Toepassing van risicomanagement
EN ISO 24415-1 NEN-EN-ISO 24415-1 Tips voor loophulpmidddelen - Eisen en beproevingsmethoden - Deel 1: Frictie van tips
ISO 24415-2 NEN-ISO 24415-2 Tips voor loophulpmiddelen - Eisen en beproevingsmethoden - Deel 2: Sterkte van doppen voor krukken
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NEN-EN 12182
CISPR 11 NEN-EN 55011 HF-apparatuur voor industriële, wetenschappelijke en medische doeleinden (zgn. ISM-apparatuur) - Radiostoringskenmerken - Grenswaarden en meetmethoden
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EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
EN 12182
May 2012
ICS 11.180.01 Supersedes EN 12182:1999
English 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 C O M I T É E U R O P É E N D E N O R M A LI S A T I O N EUR OP ÄIS C HES KOM ITEE FÜR NOR M UNG
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: E
NEN-EN 12182:2012
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EN 12182:2012 (E)
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Contents Page
Foreword ..............................................................................................................................................................5
1 Scope ......................................................................................................................................................7
2 Normative references ............................................................................................................................7
3 Terms and definitions ...........................................................................................................................9
4 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 ........................................................................................................................... 124.8 Design requirements in relation to persons with cognitive impairment....................................... 12
5 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 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 tissue ....................................................................................................................................... 155.6 Resistance to corrosion ..................................................................................................................... 15
6 Emitted sound and vibration ............................................................................................................. 156.1 Noise and vibration............................................................................................................................. 156.2 Sound levels and frequencies of audible warning devices ............................................................ 156.3 Feedback ............................................................................................................................................. 16
7 Electromagnetic compatibility ........................................................................................................... 167.1 General ................................................................................................................................................. 167.2 Emissions ............................................................................................................................................ 167.3 Immunity .............................................................................................................................................. 167.4 Power frequency magnetic field immunity ...................................................................................... 16
8 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 Electrically heated blankets, pads and similar flexible heating appliances ................................. 20
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8.8 Assistive products with skin contact electrodes ............................................................................. 208.9 Ingress of liquids ................................................................................................................................. 20
9 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 ....................................................................................................................................... 219.2.2 Test method ......................................................................................................................................... 219.3 Leakage ................................................................................................................................................ 219.4 Ingress of liquids ................................................................................................................................. 219.4.1 Requirements ....................................................................................................................................... 219.4.2 Test method ......................................................................................................................................... 22
10 Surface temperature ............................................................................................................................ 22
11 Sterility.................................................................................................................................................. 2211.1 Sterility requirements .......................................................................................................................... 2211.2 Sterilization processes ....................................................................................................................... 2211.3 Maintenance of sterility in transit ...................................................................................................... 23
12 Safety of moving parts ........................................................................................................................ 2312.1 Squeezing ............................................................................................................................................. 2312.2 Mechanical wear .................................................................................................................................. 2312.3 Emergency stopping functions .......................................................................................................... 24
13 Prevention of traps for parts of the human body ............................................................................. 2413.1 Holes and clearances .......................................................................................................................... 2413.2 V-shaped openings ............................................................................................................................. 25
14 Folding and adjusting mechanisms .................................................................................................. 2514.1 General ................................................................................................................................................. 2514.2 Locking mechanisms .......................................................................................................................... 2514.3 Guards .................................................................................................................................................. 25
15 Carrying handles ................................................................................................................................. 2515.1 General ................................................................................................................................................. 2515.2 Requirement ......................................................................................................................................... 2615.3 Test method ......................................................................................................................................... 26
16 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 .................................................................................................................................. 27
17 Portable and mobile assistive products ........................................................................................... 27
18 Surfaces, corners, edges and protruding parts ............................................................................... 29
19 Hand held assistive products............................................................................................................. 29
20 Small parts ........................................................................................................................................... 29
21 Stability ................................................................................................................................................. 29
22 Forces in soft tissues of the human body ........................................................................................ 29
23 Ergonomic principles .......................................................................................................................... 29
24 Requirements for information supplied by the manufacturer ........................................................ 3024.1 General ................................................................................................................................................. 3024.2 Instructions for use ............................................................................................................................. 3124.2.1 Pre-sale information ............................................................................................................................ 3124.2.2 User information .................................................................................................................................. 31
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24.2.3 Service information ............................................................................................................................ 3224.3 Labelling .............................................................................................................................................. 32
25 Packaging ............................................................................................................................................ 33
26 Test report ........................................................................................................................................... 33
Annex A (informative) European standards for assistive products for persons with a disability produced or currently being developed by CEN/TC 293 ................................................................ 34
Annex B (informative) General recommendations ........................................................................................ 36
Annex C (informative) Cognitive impairment ................................................................................................ 43
Annex D (informative) Environmental and consumer related requirements.............................................. 50
Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices ...................................................... 56
Bibliography ..................................................................................................................................................... 61
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EN 12182:2012 (E)
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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.
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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.
NEN-EN 12182:2012
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