EN 60601-2-2-2009 en Medical electrical equipment - Part 2-2 Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high fr.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationB S E N 6 0 6 0 1 - 2 - 2 : 2 0 0 9 + A 1 1 : 2 0 1 1M e d i c a l e l e c t r i c a l e q u i p m e n tP a r t 2 - 2 : P a r t i c u l a r r e q u i r e m e n t s f o r t h e b

2、a s i c s a f e t ya n d e s s e n t i a l p e r f o r m a n c e o f h i g h f r e q u e n c y s u r g i c a le q u i p m e n t a n d h i g h f r e q u e n c y s u r g i c a l a c c e s s o r i e sBS EN 60601-2-2:2009+A11:2011National forewordThis British Standard is the UK implementation of EN 6060

3、1-2-2:2009+A11:2011. It is identical to IEC 60601-2-2:2009.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/4, Electromedical equipment.A list of organizations represented on this subcommittee can be o

4、btained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012. Published by BSI Standards Limited 2012.ISBN 978 0 580 77240 5 ICS 11.040.30 Complia

5、nce with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2009.Amendments/corrigenda issued since publicationDate Text affectedA11:2011: Annex ZZ replacedBRITISH STANDARD

6、1 October 2014. It supersedes BS EN 60601-2-2:2009, which will be withdrawn on 31 March 2012 Implementation of CENELEC amendment EUROPEAN STANDARD EN 60601-2-2:2009+A11NORME EUROPENNE EUROPISCHE NORMCENELEC European Committee forElectrotechnicalStandardization Comit Europen de Normalisation Electrot

7、echniqueEuropisches Komitee fr Elektrotechnische NormungCentral Secretariat:Avenue Marnix 17, B - 1000 Brussels 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELECmembers.Ref. No. EN 60601-2-2:2009 EICS 11.040.30 Supersedes EN 60601-2-2:2009English v

8、ersionMedical electricalequipment - Part 2-2: Particularrequirementsfor the basic safetyand essential performanceof high frequencysurgical equipment and high frequencysurgical accessories(IEC 60601-2-2:2009)A ppareils lectromdicaux -Partie 2-2: Exigences particulires pour la scurit de base et les pe

9、rformances essentielles des appareils dlectrochirurgiecourant haute frquenceet des accessoires dlectrochirurgiecourant haute frquence (CEI 60601-2-2:2009)Medizinische elektrische Gerte -Teil 2-2: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Hochfreque

10、nz-Chirurgiegerten und HF-chirurgischem Zubehr(IEC 60601-2-2:2009)This European Standard was approved by CENELEC on 2009-04-01. CENELEC members are bound to complywith the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national stand

11、ard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained onapplication 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

12、language made by translation under the responsibility of a CENELEC member into its own language and notifiedto the Central Secretariat has the same status as the official versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, theCzech Republic, D

13、enmark, 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.October 2011Foreword The text of document 62D/726/FDIS,

14、future edition 5 of IEC 60601-2-2, prepared bySC 62D,Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to theIEC-CENELEC parallel vote and was approved by CENELEC asEN 60601-2-2 on 2009-04-01.This European Standard supersedes EN 60601-2-2:2007.Revisions

15、in EN 60601-2-2:2009 include new language for preconditioning accessories prior to insulation testing, refining the requirements for electromagnetic compatibilitytesting and correcting some of the equations used in deriving the thermal test for NEUTRAL ELECTRODES . The following dates were fixed: la

16、test date by which the EN has to be implemented at national level by publication of an identicalnational standard or by endorsement (dop) 2010-01-01 latest date by which the national standards conflictingwith the EN have to be withdrawn (dow) 2012-04-01This European Standardhas been prepared under a

17、 mandate given to CENELEC by the EuropeanCommission and the European Free Trade Association and covers essential requirements of EC Directive MDD (93/42/EEC). See Annex ZZ.In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type

18、. Informative material appearing outside of tables,such as notes, examples and references: in smaller type. Normative text oftables is also in a smaller type. T ERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD , IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS.In referring to the structure of

19、 this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents,inclusive of allsubdivisions (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 7.2.1 are all subclauses ofClause 7).R

20、eferences to clauses within this standard are preceded by the term “Clause” followed by the clausenumber. References to subclauses within this particular standard are by number only.In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combinationof the co

21、nditions is true.The verbal forms used in this standard conform to usage described in Annex H 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 thisstandard; “should” me

22、ans that compliance with a requirement or a test is recommended but is not mandatory forcompliance with this standard; “may”is used to describe a permissible way to achieve compliance with a requirement or test. BS EN 60601-2-2:2009+A11:2011 EN 60601-2-2:2009+A11:2011 (E) 2 An asterisk(*) as the fir

23、st character of a title or at the beginning of a paragraph or table title indicates thatthere is guidance or rationale related to that item in Annex AA.Annexes ZA and ZZ have been added by CENELEC._Endorsement noticeThe text of the International Standard IEC 60601-2-2:2009 was approved by CENELEC as

24、 a European Standard without any modification.In the official version, for Bibliography, the following note has to be added for the standard indicated:IEC 60601-2-18 + A1 NOTE Harmonized as EN 60601-2-18:1996 + A1:2000 (not modified)._Foreword to amendment A11This document (EN 60601-2-2:2009/A11:201

25、1) has been prepared by CLC/TC 62 “Electrical equipment in medical practice”. The following dates are fixed: latest date by which this document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2012-10-01 latest date by which the nationa

26、l standards conflicting with this document have to be withdrawn (dow) 2014-10-01 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. BS EN

27、 60601-2-2:2009+A11:2011 EN 60601-2-2:2009+A11:2011 (E) 3 A nnex ZA(normative)Normative references to international publicationswith their corresponding European publicationsThe following referenced documents are indispensable for the application of this document. For dated references, only the edit

28、ion cited applies . For undated references, the latest edition of the r eferenceddocument (including any amendments) applies.NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HDapplies.Annex ZA of EN 60601-1:2006 applies, except as

29、follows: Publication Year Title EN/HD YearReplace the references to IEC 60601-1-2 and IEC 60601-1-8 by:IEC 60601-1-2(mod)2007 Medical electrical equipment -Part 1-2: General requirements for basicsafety and essential performance - Collateral Standard: Electromagnetic compatibility -Requirements and

30、testsEN 60601-1-22007IEC 60601-1-82006 Medical electrical equipment -Part 1-8: General requirements for basicsafety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medicalelectrical equipment and medical electricalsystemsEN 60601-1-82007

31、Addition: IEC 61000-4-32006 Electromagnetic compatibility (EMC) -Part 4-3: Testing and measurement techniques - Radiated, radio-frequency,electromagnetic field immunity testEN 61000-4-3+ IS120062009IEC 61000-4-62003 Electromagnetic compatibility (EMC) -Part 4-6: Testing and measurement techniques -

32、Immunityto conducted disturbances, induced by radio-frequencyfieldsEN 61000-4-6 1)+ corr. August + IS1200720072009CISPR 11 (mod) 2003 Industrial scientific and medical (ISM)radio-frequency equipment -Electromagneticdisturbance characteristics- Limits and methods ofmeasurement EN 55011 2) 20071) EN 6

33、1000-4-6:2007 includes A1:2004 + A2:2006 to IEC 61000-4-6:2003. It is superseded by EN 61000-4-6:2009, which isbased on IEC 61000-4-6:2008.2) EN 55011:2007 includes A1:2004 (mod) to CISPR 11:2003 (mod).BS EN 60601-2-2:2009+A11:2011 EN 60601-2-2:2009+A11:2011 (E) 4 Annex ZZ (informative) Coverage of

34、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 Directive 93

35、/42/EEC except as follows: Essential Requirement 6a Essential Requirement 7.4 Essential Requirement 7.5 paragraph 2 where it is intended that any partof the generalstandardor applicable collateral standard, although possibly relevant, is nottobe applied, a statement to that effect isgiven in this pa

36、rticular standard.201.2 NormativereferencesNOTE Informative references are listed in the bibliography beginning on page 79.Clause 2 ofthe generalstandard applies, except asfollows:Replacement:IEC 60601-1-2:2007, Medical electrical equipment Part 1-2:General requirements forbasic safety and essential

37、 performance Collateral standard: ElectromagneticcompatibilityRequirements and tests BS EN 60601-2-2:2009+A11:2011 EN 60601-2-2:2009+A11:2011 (E) 10 IEC 60601-1-8:2006, Medical electrical equipment Part 1-8:General requirements forbasic safety and essential performance Collateral standard: General r

38、equirements, testsand guidance for alarmsystems in medical electrical equipment and medical electrical systemsAddition:IEC 61000-4-3:2006, Electromagnetic compatibility (EMC) Part4-3: T esting and measurement techniques Radiated, radio-frequency electromagnetic field immunitytestIEC 61000-4-6:2003,

39、Electromagnetic compatibility (EMC) Part4-6: T esting and measurement techniques Immunity to conducted disturbances, induced by radio-frequencyfieldsCISPR 11:2003, Industrial, scientificand medical (ISM) radio-frequency equipmentElectromagnetic disturbance characteristics Limits and methods ofmeasur

40、ement201.3Terms and definitionsForthe purposes of this document, the terms and definitions given in IEC 60601-1:2005,apply, except asfollows:Replace NOTE 1 with the following:NOTE 1 Where the terms “voltage” and “current” are used in this document, they mean the r.m.s. values of analternating, direc

41、t or composite voltage or current averaged over 1 s unless stated otherwise.Addition:201.3.201ACTIVE ACCESSORYHF SURGICAL ACCESSORY intended for manipulationbythe OPERATOR toproduce surgicaleffects at the intended site on the PATIENT ,generally comprising an ACTIVE HANDLE , the cordofan ACTIVE ACCES

42、SORY, ACTIVE CONNECTOR and ACTIVE ELECTRODE201.3.202ACTIVE CONNECTORpart of an ACTIVE ACCESSORY intended for connection to an ACTIVE OUTPUT TERMINAL , which may include additional terminals for connection of a FINGERSWITCH toaSWITCH SENSOR201.3.203ACTIVE ELECTRODEpart of an ACTIVE ACCESSORY extendin

43、g from the ACTIVE HANDLE to the surgical site201.3.204ACTIVE ELECTRODE INSULATIONelectrical insulationmaterial affixed to part of an ACTIVE ELECTRODE intended to preventunintended injury to the OPERATOR oradjacent PATIENT tissue 201.3.205ACTIVE HANDLEpart of an ACTIVE ACCESSORY intended to be held b

44、y the OPERATOR201.3.206ACTIVE OUTPUT TERMINALpart of HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT intended for connection to an ACTIVE ACCESSORY and for delivery of HF current thereto BS EN 60601-2-2:2009+A11:2011 EN 60601-2-2:2009+A11:2011 (E) 11 201.3.207* ASSOCIATED EQUIPMENTequipment other than

45、 HF SURGICAL EQUIPMENT that may be electrically connected tothe PATIENT circuit and not intended for independent use201.3.208* BIPOLARmethod of applying HF output current to a PATIENT via multiple-pole ACTIVE ELECTRODES201.3.209BIPOLAR ELECTRODEassembly oftwo ormore ACTIVE ELECTRODES on the same sup

46、port, so constructed that, when energized, the HF current flows mainlyamongst theseelectrodes201.3.210COAGULATIONuse of HF current to elevate the temperature of tissue, e.g. to reduce or terminate undesiredbleedingNOTE COAGULATION may take the form of contact or non-contact COAGULATION . 201.3.211CO

47、NTACT QUALITY MONITORCQMcircuit in HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT intended for connectiontoa MONITORING NE providing an alarm in the event that NEUTRAL ELECTRODE ( NE)contact with thePATIENT becomes insufficientNOTE A CONTACT QUALITY MONITOR is functional only when used with a MONITOR

48、ING NE. 201.3.212CONTINUITY MONITORcircuit in HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT intended for connection to an NE, except MONITORING NE,providingan alarm inthe eventof electrical disco ntinuityin the NEcable or its connections201.3.213* CREST FACTORdimensionless value equal to the peak ou

49、tput voltage divided bythe r.m.s. voltage asmeasured atthe output of HF SURGICAL EQUIPMENT in an open circuit conditionNOTE Specific information on the correctway to make the measurements needed to calculate this value may be found in Annex AA.201.3.214* CUTTINGresection or dissection of body tissue caused by the passage of HIGH FREQUENCY current ofhigh current densityatthe ACTIVE ELECTRODE ( S ) 201.3.215* EARTH REFERENCED PATIENTCIRCUITPATIENT circuitwhich includes components, such as cap