MEDICAL ELECTRICAL EQUIPMENT --

Transcription

1 IRISH STANDARD I.S. EN :2006 ICS National Standards Authority of Ireland Glasnevin, Dublin 9 Ireland MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL Tel: Fax: Sales PERFORMANCE (IEC :2005 (EQV)) NSAI 2006 Údarás um Chaighdeáin Náisiúnta na héireann This Irish Standard was published under the authority of the National Standards Authority of Ireland and comes into effect on: 15 November 2006 NO COPYING WITHOUT NSAI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Price Code XX

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3 EUROPEAN STANDARD EN NORME EUROPÉENNE EUROPÄISCHE NORM October 2006 ICS Supersedes EN : amendments English version Medical electrical equipment for basic safety and essential performance (IEC :2005) Appareils électromédicaux Partie 1: Exigences générales pour la sécurité de base et les performances essentielles (CEI :2005) Medizinische elektrische Geräte Teil 1: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale (IEC :2005) This European Standard was approved by CENELEC on CENELEC 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. Uptodate lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC 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 CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B 1050 Brussels 2006 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN :2006 E

4 EN : Foreword The text of document 62A/505A//FDIS, future edition 3 of IEC , prepared by SC 62A, Common aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IECCENELEC parallel vote and was approved by CENELEC as EN on The following date was fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) This European Standard supersedes EN :1990 and its amendments. However, EN :1990 remains valid until all the parts 2 that are used in conjunction with it have been withdrawn. No date of withdrawal of conflicting national standards (dow) has therefore been fixed. However, when Part 1 is used for appliances not covered by a part 2, EN :1990 is not to be used after This EN :2006 has been significantly restructured compared to EN :1990. Requirements in the electrical section have been further aligned with those for information technology equipment covered by EN and a requirement for including a RISK MANAGEMENT PROCESS has been added. For an expanded description of this revision, see Clause A.3. This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directives 90/385/EEC and 93/42/EEC. See Annex ZZ. In this standard the following print types are used: requirements and definitions: in roman type; test specifications: in italic type; informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type; TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3 AND ALSO GIVEN IN THE INDEX: IN SMALL CAPITALS. In referring to the structure of this standard, the term clause means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); subclause means a numbered subdivision of a clause (e.g. 7.1, 7.2 and are all subclauses of Clause 7). References to clauses within this standard are preceded by the term Clause followed by the clause number. References to subclauses within this standard are by number only. In this standard, the conjunctive or is used as an inclusive or so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex G of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: shall means that compliance with a requirement or a test is mandatory for compliance with this standard; should means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; may is used to describe a permissible way to achieve compliance with a requirement or test.

5 3 EN :2006 An asterisk (* ) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A. Annexes ZA and ZZ have been added by CENELEC. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC NOTE Harmonized as EN 60073:2002 (not modified). IEC NOTE Harmonized as EN :2001 (not modified). IEC NOTE Harmonized as EN :1994 (not modified). IEC NOTE Harmonized as EN :1999 (not modified). IEC NOTE Harmonized as EN : (not modified). IEC NOTE Harmonized as EN :2001 (not modified). IEC NOTE Harmonized as EN : :1999 (not modified). IEC NOTE Harmonized as EN :2001 (not modified). IEC NOTE Harmonized as EN :2000 (not modified). IEC series NOTE Harmonized in EN series (not modified). IEC NOTE Harmonized as EN 60990:1999 (not modified). IEC NOTE Harmonized as EN : (not modified). IEC NOTE Harmonized as EN :2001 (not modified). IEC NOTE Harmonized as EN 61140:2002 (not modified). IEC NOTE Harmonized as EN 62079:2001 (not modified). IEC NOTE Harmonized as EN 62304:2006 (not modified). ISO 407 NOTE Harmonized as EN ISO 13407: (not modified). ISO 8041 NOTE Harmonized as EN ISO 8041:2005 (not modified). ISO NOTE Harmonized as EN ISO 13485:2003 (not modified). Endorsement notice The text of the International Standard IEC :2005 was approved by CENELEC as a European Standard without any modification.

6 EN : Annex ZA (normative) Normative references to international publications with their corresponding European publications The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Publication Year Title EN/HD Year IEC (mod) 2001 Audio, video and similar electronic EN apparatus Safety requirements + corr. March 2006 IEC Environmental testing Part 2: Tests Tests B: Dry heat EN ) IEC (mod) 2) Electrical apparatus for explosive gas atmospheres Part 0: General requirements EN ) IEC ) Electrical apparatus for explosive gas atmospheres Part 2: Pressurized enclosures "p" IEC ) Electrical apparatus for explosive gas atmospheres Part 5: Powder filling 'q' EN corr. April 3) 2006 IEC ) Electrical apparatus for explosive gas atmospheres Part 6: Oilimmersion "o" IEC ) Plugs and socketoutlets for domestic and similar general use standardized in member countries of IEC IEC ) Electrical insulation Thermal classification EN ) IEC ) Primary batteries Part 4: Safety of lithium batteries EN ) IEC ) Method for the determination of the proof EN ) and the comparative tracking indices of solid insulating materials 1) 2) 3) EN includes supplement A:1976 to IEC Undated reference. Valid edition at date of issue.

7 5 EN :2006 Publication Year Title EN/HD Year IEC Miniature fuses Part 1: Definitions for miniature fuses and general requirements for miniature fuselinks EN IEC ) Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V IEC ) 2003 Rubber insulated cables Rated voltages up to and including 450/750 V IEC ) AC motor capacitors Part 1: General Performance, testing and rating Safety requirements Guide for installation and operation IEC ) Appliance couplers for household and similar general purposes EN ) EN ) IEC (mod) 2001 Household and similar electrical appliances Safety EN corr. July IEC (mod) 2005 Lowvoltage electrical installations Part 441: Protection for safety Protection against electric shock HD IEC Fixed capacitors for use in electronic equipment Part 14: Sectional specification Fixed capacitors for electromagnetic interference suppression and connection to the supply mains EN IEC Data base Graphical symbols for use on equipment IEC ) Basic and safety principles for manmachine interface, marking and identification Identification of equipment terminals and of terminations of certain designated conductors, including general rules for an alphanumeric system IEC ) Basic and safety principles for manmachine interface, marking and identification Actuating principles EN ) EN ) 4) HD 21.1 S4:2002, Cables of rated voltages up to and including 450/750 V and having thermoplastic insulation, which is related to, but not directly equivalent with, IEC , applies instead. 5) HD 22.1 S4:2002, Cables of rated voltages up to and including 450/750 V and having crosslinked insulation Part 1: General requirements, which is related to, but not directly equivalent with, IEC , applies instead.

8 EN : Publication Year Title EN/HD Year IEC Degrees of protection provided by enclosures (IP Code) 1999 EN corr. May IEC ) Medical electrical equipment Part 12: General requirements for safety Collateral standard: Electromagnetic compatibility Requirements and tests IEC ) Medical electrical equipment for safety 3. Collateral standard: General requirements for radiation protection in diagnostic Xray equipment IEC ) Medical electrical equipment Part 16: General requirements for safety Collateral standard: Usability EN ) EN ) EN ) IEC ) Medical electrical equipment Part 18: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EN corr. October 3) 2006 IEC (mod) Insulation coordination for equipment within lowvoltage systems Part 1: Principles, requirements and tests EN IEC ) Fire hazard testing Part 1110: Test flames 50 W horizontal and vertical flame test methods EN ) IEC (mod) (mod) Automatic electrical controls for household and similar use EN IEC IEC IEC IEC Safety of laser products Part 1: Equipment classification, requirements and user's guide Winding wires Test methods Part 3: Mechanical properties Winding wires Test methods Part 5: Electrical properties Winding wires Test methods Part 6: Thermal properties IEC/TR Graphical symbols for electrical equipment in medical practice EN corr. February + corr. April EN EN EN

9 7 EN :2006 Publication Year Title EN/HD Year IEC ) Plugs and socketoutlets for household and similar purposes IEC (mod) 2001 Information technology equipment Safety EN ) + corr. April IEC (mod) Switches for appliances EN IEC (mod) 1998 Safety of power transformers, power supply units and similar and tests EN ) + corr. April IEC ) Safety of power transformers, power supply units and similar Part 21: Particular requirements for separating transformers for general use IEC ) Electroacoustics Sound level meters Part 1: Specifications IEC ) Electroacoustics Sound level meters Part 2: Pattern evaluation tests EN ) EN ) EN ) IEC ) Mechanical safety of cathode ray tubes EN ) ISO 31 Series Quantities and units of space and time ISO 780 2) Packaging Pictorial marking for handling of goods ISO ) SI units and recommendations for the use of their multiples and of certain other units EN ISO ISO ) Conducting and dissipative rubbers, vulcanized or thermoplastic Measurement of resistivity ISO ) Rubber, vulcanized Antistatic and conductive products Determination of electrical resistance ISO ) Rubber, vulcanized Antistatic and conductive products for hospital use Electrical resistance limits 6) 7) EN is superseded by EN :2006, which is based on IEC :2005, mod. EN is superseded by EN :2005, which is based on IEC :2005.

10 EN : Publication Year Title EN/HD Year ISO ) Acoustics Determination of sound power levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane EN ISO ISO Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs in workplaces and public areas Annex ZZ (informative) Coverage of Essential Requirements of EC Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directives 90/385/EEC and 93/42/EEC. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directives concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard.

11 NORME INTERNATIONALE INTERNATIONAL STANDARD CEI IEC Troisième édition Third edition Appareils électromédicaux Partie 1: Exigences générales pour la sécurité de base et les performances essentielles Medical electrical equipment Part 1: General requirements for basic safety and essential performance Numéro de référence Reference number CEI/IEC :2005

12 Numérotation des publications Depuis le 1er janvier, les publications de la CEI sont numérotées à partir de Ainsi, la CEI 341 devient la CEI Publication numbering As from 1 January all IEC publications are issued with a designation in the series. For example, IEC 341 is now referred to as IEC Editions consolidées Les versions consolidées de certaines publications de la CEI incorporant les amendements sont disponibles. Par exemple, les numéros d édition 1.0, 1.1 et 1.2 indiquent respectivement la publication de base, la publication de base incorporant l amendement 1, et la publication de base incorporant les amendements 1 et 2. Consolidated editions The IEC is now publishing consolidated versions of its publications. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the base publication incorporating amendment 1 and the base publication incorporating amendments 1 and 2. Informations supplémentaires sur les publications de la CEI Le contenu technique des publications de la CEI est constamment revu par la CEI afin qu'il reflète l'état actuel de la technique. Des renseignements relatifs à cette publication, y compris sa validité, sont disponibles dans le Catalogue des publications de la CEI (voir cidessous) en plus des nouvelles éditions, amendements et corrigenda. Des informations sur les sujets à l étude et l avancement des travaux entrepris par le comité d études qui a élaboré cette publication, ainsi que la liste des publications parues, sont également disponibles par l intermédiaire de: Site web de la CEI ( Catalogue des publications de la CEI Le catalogue en ligne sur le site web de la CEI ( vous permet de faire des recherches en utilisant de nombreux critères, comprenant des recherches textuelles, par comité d études ou date de publication. Des informations en ligne sont également disponibles sur les nouvelles publications, les publications remplacées ou retirées, ainsi que sur les corrigenda. IEC Just Published Ce résumé des dernières publications parues ( est aussi disponible par courrier électronique. Veuillez prendre contact avec le Service client (voir cidessous) pour plus d informations. Service clients Si vous avez des questions au sujet de cette publication ou avez besoin de renseignements supplémentaires, prenez contact avec le Service clients: custserv@iec.ch Tél: Fax: Further information on IEC publications The technical content of IEC publications is kept under constant review by the IEC, thus ensuring that the content reflects current technology. Information relating to this publication, including its validity, is available in the IEC Catalogue of publications (see below) in addition to new editions, amendments and corrigenda. Information on the subjects under consideration and work in progress undertaken by the technical committee which has prepared this publication, as well as the list of publications issued, is also available from the following: IEC Web Site ( Catalogue of IEC publications The online catalogue on the IEC web site ( enables you to search by a variety of criteria including text searches, technical committees and date of publication. Online information is also available on recently issued publications, withdrawn and replaced publications, as well as corrigenda. IEC Just Published This summary of recently issued publications ( is also available by . Please contact the Customer Service Centre (see below) for further information. Customer Service Centre. If you have any questions regarding this publication or need further assistance, please contact the Customer Service Centre: custserv@iec.ch Tel: Fax:

13 I.S. EN :2006 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance The remainder of this document is available for purchase online at SAI Global also carries a wide range of publications from a wide variety of Standards Publishers: Click on the logos to search the database online.