EN 80601-2-58-2009 en Medical electrical equipment - Part 2-58 Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationM 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 - 5 8 : 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 a s i c s a f e t y a n d e s s e n t i a l p e r f

2、 o r m a n c e o f l e n s r e m o v a l d e v i c e s a n d v i t r e c t o m y d e v i c e s f o r o p h t h a l m i c s u r g e r yB S E N 8 0 6 0 1 - 2 - 5 8 : 2 0 0 9 + A 1 1 : 2 0 1 1National forewordT h e U K p a r t i c i p a t i o n i n i t s p r e p a r a t i o n w a s e n t r u s t e d b

3、y Te c h n i c a l C o m m i t t e eC H / 6 2 , E l e c t r o m e d i c a l E q u i p m e n t i n M e d i c a l P r a c t i c e , t o S u b c o m m i t t e eC H / 6 2 / 4 , E l e c t r o m e d i c a l e q u i p m e n t , w i t h c o n t r i b u t i o n f r o m C H / 1 7 2 ,O p h t h a l m i c o p t

4、i c s .A l i s t o f o r g a n i z a t i o n s r e p r e s e n t e d o n t h i s s u b c o m m i t t e e c a n b e o b t a i n e d o nr e q u e s t t o i t s s e c r e t a r y.T h i s p u b l i c a t i o n d o e s n o t p u r p o r t t o i n c l u d e a l l t h e n e c e s s a r y p r o v i s i o n

5、s o f ac o n t r a c t . U s e r s a r e r e s p o n s i b l e f o r i t s c o r r e c t a p p l i c a t i o n .ISBN 978 0 580 77239 9ICS 11.040.70BRITISH STANDARDB S E N 8 0 6 0 1 - 2 - 5 8 : 2 0 0 9 + A 1 1 : 2 0 1 1Compliance with a British Standard cannot confer immunity from legal obligations.T

6、his British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2009A m e n d m e n t s / c o r r i g e n d a i s s u e d s i n c e p u b l i c a t i o nDate Text affected T h e B r i t i s h S t a n d a r s I n s t i t u t i o n 2 0 1 2P u b l i s h

7、 e d b y B S I S t a n d a r d s L i m i t e d 2 0 1 2T h i s B r i t i s h S t a n d a r d i s t h e U K i m p l e m e n t a t i o n o f1 O c t o b e r 2 0 1 4 .I t s u p e r s e d e s B S E N 8 0 6 0 1 - 2 - 5 8 : 2 0 0 9 ,E N 8 0 6 0 1 - 2 - 5 8 : 2 0 0 9 + A 1 1 : 2 0 1 1 . I t i s d e r i v e d

8、 f r o m I E C 8 0 6 0 1 - 2 - 5 8 : 2 0 0 8 .w h i c h w i l l b e w i t h d r a w n o n2 9 F e b r u a r y 2 0 1 2 I m p l e m e n t a t i o n o f C E N E L E C a m e n d m e n t A 1 1 : 2 0 1 1 :A n n e x Z Z r e p l a c e dEUROPEAN STANDARD EN 80601-2-58:2009+A11NORME EUROPENNE EUROPISCHE NORMCE

9、NELEC European Committee forElectrotechnicalStandardization Comit Europen de Normalisation ElectrotechniqueEuropisches 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

10、 for CENELECmembers.Ref. No. EN 80601-2-58:2009 EICS 11.040.70English versionMedical electricalequipment - Part 2-58: Particular requirements for the basic safetyand essential performance of lens removal devices and vitrectomydevices for ophthalmic surgery(IEC 80601-2-58:2008)A ppareils lectromdicau

11、x -Partie 2-58: Exigences particulires pour la scurit de base et les performances essentielles des dispositifs de retrait du cristallinet des dispositifs de vitrectomie pour la chirurgie ophtalmique(CEI 80601-2-58:2008)Medizinische elektrische Gerte -Teil 2-58: Besondere Festlegungen fr die Sicherhe

12、it einschlielich der wesentlichen Leistungsmerkmale fr Gerte zur Linsenentfernungund Gerte zur Glaskrperentfernungin der Augenchirurgie(IEC 80601-2-58:2008)This European Standard was approved by CENELEC on 2009-02-01. CENELEC members are bound to complywith the CEN/CENELEC Internal Regulations which

13、 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 onapplication to the Central Secretariat or to any CENELEC member. This European St

14、andard exists in three official versions (English, French, German). A version in any otherlanguage 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 nation

15、al electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, theCzech 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, S

16、witzerland and the United Kingdom.October 2011Foreword The text of document 62D/701/FDIS, future edition 1 of IEC 80601-2-58, prepared bySC 62D,Electromedical equipment, of IEC TC 62, Electricalequipment in medical practice, and SC 7, Ophthalmic optics and instruments, of ISO TC 172, Optics and phot

17、onics, was submitted to the IEC-CENELECparallel vote and was approved by CENELEC as EN 80601-2-58 on 2009-02-01.The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identicalnational standard or by endorsement (dop) 2009-11-01 lates

18、t date by which the national standards conflictingwith the EN have to be withdrawn (dow) 2012-02-01This European Standardhas been prepared under a mandate given to CENELEC by the EuropeanCommission and the European Free Trade Association and covers essential requirements of EC Directive MDD (93/42/E

19、EC). See Annex ZZ.In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables,such as notes, examples and references: in smaller type. Normative text oftables is also in a smaller t

20、ype. 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 this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents,inclusive of allsubdivisions (e.g. Clause 7 in

21、cludes 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).References to clauses within this standard are preceded by the term “Clause” followed by the clausenumber. References to subclauses within this particular s

22、tandard 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 conditions 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 st

23、andard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with thisstandard; “should” means that compliance with a requirement or a test is recommended but is not mandatory forcompliance with this standard; “may”is used to describe a permissib

24、le way to achieve compliance with a requirement or test. An asterisk(*) as the first 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.BS EN 80601-2-58:2009+A11:2011 EN 80601-2-58:2009+A11:2011 (E) 2 A

25、nnexes ZA and ZZ have been added by CENELEC._Endorsement noticeThe textofthe International Standard IEC 80601-2-58:2008 was approved by CENELEC asa European Standard without any modification.In the official version, for Bibliography, the following notes have to be added for the standards indicated:I

26、EC 60065 NOTE Harmonized as EN 60065:2002 (modified).IEC 60825-1 NOTE Harmonized as EN 60825-1:2007 (not modified).IEC 60950-1 NOTE Harmonized as EN 60950-1:2006 (modified).ISO 15004-2 NOTE Harmonized as EN ISO 15004-2:2007 (not modified)._Foreword to amendment A11 This document (EN 80601-2-58:2009/

27、A11:2011) 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

28、national 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

29、. BS EN 80601-2-58:2009+A11:2011 EN 80601-2-58:2009+A11:2011 (E) 3 A nnex ZA(normative)Normative references to international publicationswith their corresponding European publicationsThe following referenced documents are indisp ensable for the application of this document. For dated references, onl

30、y the edition cited applies. For undated references, the latest edition of the referenceddocument (including any amendments) applies.NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HDapplies.Publication Year Title EN/HD YearIEC 60

31、601-1-2 (mod)2007 Medical electrical equipment -Part 1-2: General requirements for basicsafety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and testsEN 60601-1-22007IEC 60601-2-2200X Medical electrical equipment -Part 2-2: Particular requirements for b

32、asicsafety and essential performance of high frequency surgical equipment and highfrequency surgical accessoriesEN 60601-2-2200XIEC 60601-2-22 - 1) Medical electrical equipment -Part 2-22: Particular requirements for basicsafety and essential performance of surgical, cosmetic, therapeutic and diagno

33、stic laserequipment - - IEC 618471998 Ultrasonics - Surgical systems -Measurement and declaration of the basicoutput characteristicsEN 618471998ISO 11607-12006 Packaging for terminally sterilized medical devices -Part 1: Requirements for materials, sterile barrier systems and packaging systems EN IS

34、O 11607-12006ISO 11607-22006 Packaging for terminally sterilized medical devices -Part 2: Validation requirements for forming, sealing and assembly processesEN ISO 11607-22006ISO 15752 2000 Ophthalmic instruments - Endoilluminators -Fundamental requirements and test methodsfor optical radiation safe

35、ty- - ISO 17664 2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devicesEN ISO 17664 20041) Undated reference.BS EN 80601-2-58:2009+A11:2011 EN 80601-2-58:2009+A11:2011 (E) 4 Annex ZZ (informative) Coverage of Essenti

36、al 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 93/42/EEC

37、 except as follows: Essential Requirement 6a Essential Requirement 7.4 Essential Requirement 7.5 paragraph 2 where it is intended that any part of the general standardor applicable collateral standard,although possibly relevant, is nottobe applied, astatement to that effect isgiven in this particula

38、r standard.201.2 NormativereferencesNOTE Informative references are listed in the bibliography beginning on page 25.Clause 2 ofthe generalstandard applies, except asfollows:Addition:IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: Generalrequirements for basicsafety and essential performan

39、ce Collateral standard: Electromagnetic compatibility -Requirements and testsBS EN 80601-2-58:2009+A11:2011 EN 80601-2-58:2009+A11:2011 (E) 9 IEC 60601-2-2, Medicalelectrical equipment Part 2-2: Partic ular requirements for the basicsafety and essential performan ce of high frequency surgical equipm

40、ent and highfrequency surgical accessories2)IEC 60601-2-22, Medical electrical equipment Part 2-22: Particularrequirementsfor the basic safetyand essential performance of surgical, cosmetic, therapeuticand diagnosticlaserequipmentIEC 61847:1998, Ultrasonics Surgical systems Measurementand de clarati

41、on of the basicoutput characteristicsISO 11607-1:2006, Packaging for terminally sterilized medical devices Part 1:Requirementsfor materials, sterile barrier systems and packaging systemsISO 11607-2:2006, Packaging for terminallysterilized medical devices Part 2: Validation requirements for forming,

42、sealing andassemblyprocessesISO 15752:2000, Ophthalmic instruments Endoilluminators Fundamental requirementsand test methods for optical radiation safetyISO 17664:2004, Sterilization ofmedicaldevices Inform ation to be provided by themanufacturer for the processing ofresterilizable medical devices 2

43、01.3Terms and definitionsForthe purposes of this document, the terms and definitions given in IEC 60601-1:2005, apply, except asfollows:NOTE An index of defined terms is found beginning on page26.Addition:201.3.201ASPIRATIONdrawingfluid or gas out ofthe eye by use of suc tion 201.3.202DIATHERMYsurgi

44、cal technique using high frequency (HF) electrical currentsused forexample to coagulate blood or bind tissues togetherNOTE The terms “cautery” or “coagulation” have also been used in this context.201.3.203DRAIN CONTAINERsealed container (or bag) in which aspirated fluid is collected201.3.204HANDPIEC

45、EPROBEhandheld APPLIED PART ,an ACCESSORY of LENS REMOVAL DEVICES or VITRECTOMY DEVICES 2) 5th edition, to be published. The title of the fourth edition is IEC 60601-2-2:2006, Medical electrical equipment Part 2-2: Particular requirements for the safety of high frequency surgical equipment. BS EN 80

46、601-2-58:2009+A11:2011 EN 80601-2-58:2009+A11:2011 (E) 10 201.3.205LASERanydevice which can be made to produce or amplifyelectromagnetic radiation in thewavelength range from 180nm to 1mm primarily by the pr ocessof controlled stimulatedemissionIEC 60825-1:2007, definition 3.41201.3.206LASER FRAGMEN

47、TATIONmethod by which the lens is broken into small fragments using LASER energy201.3.207LENS REMOVALremoval of unwanted lens tissue201.3.208LENS REMOVAL DEVICEME EQUIPMENT or ME SYSTEM designed to remove lens material which incorporates anIRRIGATION and ASPIRATION function, and a mechanism for LENS

48、 REMOVAL suchas PHACOEMULSIFICATION , LIQUEFACTION ,or LASER FRAGMENTATIONNOTE These devices may also be used for other ocular surgical purposes.201.3.209LIQUEFACTION FRAGMENTATIONLIQUEFACTIONmethod by which the lens is broken into small fragments bymeans ofpulses of ophthalmicIRRIGATION solution201

49、.3.210OCULAR IRRIGATIONIRRIGATIONintroduction of a liquid into the eyeNOTE The term “infusion” has also been used in this context201.3.211PHACOFRAGMENTATIONmethodbywhich the lens is broken into small fragments using energy such as from ultrasonicdevices NOTE Refer to the definition of LENS REMOVAL DEVICE in 201.3.208.Historically PHACOFRAGMENTATION (term is also identified as phacoemulsification) has been a surgical PROCEDUREthat uses ultrasonic energy to fragment (or emul