BS EN 45502-2-2-2008 Active implantable medical devices - Part 2-2 Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implan.pdf

1、BRITISH STANDARDBS EN 45502-2-2:2008Active implantable medical devices Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)ICS 11.040.40g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g

2、53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58April 2009corrigendumIncorporatingNational forewordThis British Standard is the UK implementation of EN 45502-2-2:2008, incorporating corrigendum April 2009. Together with

3、BS EN 45502-2-1:2003, it supersedes BS 6902-1:1990 and BS 6902-1:Supplement No. 1:1996 which are withdrawn.The start and finish of text introduced or altered by corrigendum is indicated in the text by tags. Text altered by CENELEC corrigendum April 2009 is indicated in the text by .The UK participat

4、ion in its preparation was entrusted by Technical Committee CH/150, Implants for surgery, to Subcommittee CH/150/6, Active surgical implants. A list of organizations represented on this subcommittee can be obtained on request to its secretary. This publication does not purport to include all the nec

5、essary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. BS EN 45502-2-2:2008This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 Octob

6、er 2008 BSI 2010Amendments/corrigenda issued since publicationDate Comments 31 January 2010 Implementation of CENELEC corrigendum April 2009ISBN 978 0 580 68130 1EUROPEAN STANDARD EN 45502-2-2 NORME EUROPENNE EUROPISCHE NORM March 2008 CENELEC European Committee for Electrotechnical Standardization

7、Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 45502-2-2:2008 E ICS

8、11.040.40 Partially supersedes EN 50061:1988 + A1:1995English version Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) Dispositifs mdicaux implantables actifs - Partie

9、 2-2: Exigences particulires pour les dispositifs mdicaux implantables actifs destins au traitement des tachyarythmies (y compris les dfibrillateurs implantables)Aktive implantierbare Medizingerte - Teil 2-2: Besondere Festlegungen fr aktive implantierbare medizinische Produkte zur Behandlung von Ta

10、chyarrhythmie (einschlielich implantierbaren Defibrillatoren) This European Standard was approved by CENELEC on 2007-05-01. 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

11、 without any alteration. Up-to-date 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 l

12、anguage 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, Bulgaria, Cyprus, the Czech Republic,

13、 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. Incorporating corrigendum April 2009- 2 - Foreword T

14、his European Standard was prepared by the CEN/CENELEC Joint Working Group on ACTIVE IMPLANTABLE MEDICAL DEVICES (CEN/CLC JWG AIMD). The text of the draft was submitted to the formal vote and was approved by CENELEC as EN 45502-2-2 on 2007-05-01. This European Standard, together with EN 45502-2-1:200

15、3, supersedes EN 50061:1988 + A1:1995 (+ corrigendum October 1995). The following dates were 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) 2008-10-01 latest date by which the national standards conf

16、licting with the EN have to be withdrawn (dow) 2010-05-01 The requirements of this Particular Standard supplement or modify those of EN 45502-1:1997, active implantable medical devices Part 1: General requirements for safety, marking and information to be provided by the manufacturer. This European

17、Standard has been prepared by the CEN/CENELEC Joint Working Group on Active Implantable Medical Devices (CEN/CLC JWG AIMD). Members of the Joint Working Group were nominated by one of the members of either CEN or CENELEC. This European Standard has been prepared under mandates given to CEN and CENEL

18、EC by the Commission of the European Communities and the European Free Trade Association, and supports the essential requirements of Directive 90/385/EEC Council Directive of June 1990 on the approximation of the laws of the Member states relating to active implantable medical devices. Although both

19、 this Particular Standard and the Directive deal with the same products, the structure and purpose of the two documents are different. Annex AA of this Particular Standard correlates the requirements of the Directive with the subclauses of EN 45502-1:1997 and of this Particular Standard. Annex BB pr

20、ovides references in the other direction, from this European Standard to the Directive. Annex CC is a rationale providing some further explanation of the subclauses of this Particular Standard. _ BS EN 45502-2-2:2008EN 45502-2-2:2008In this standard, the following print types are used: Requirements

21、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 of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD

22、 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 all subdivisions (e.g. Clause 7 includes Subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a

23、clause (e.g. 7.1, 7.2 and 7.2.1 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 collateral standard are by number only. In this standard, the conjunctive “or” is used as

24、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 H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requireme

25、nt 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. - 3 - Contents

26、 1 Scope . 7 2 Normative references . 7 3 Definitions 8 4 Symbols and abbreviations (optional) . 11 5 General requirements for non-implantable parts . 11 6 Measurement of IMPLANTABLE PULSE GENERATOR and LEAD characteristics . 12 7 General arrangement of the packaging . 14 8 General MARKINGS for ACTI

27、VE IMPLANTABLE MEDICAL DEVICES 14 9 MARKINGS on the SALES PACKAGING . 15 10 Construction of the SALES PACKAGING 16 11 MARKINGS on the STERILE PACK 16 12 Construction of the NON-REUSABLE PACK 16 13 MARKINGS on the ACTIVE IMPLANTABLE MEDICAL DEVICE . 17 14 Protection from unintended biological effects

28、 being caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE . 17 15 Protection from HARM to the patient or user caused by external physical features of the ACTIVE IMPLANTABLE MEDICAL DEVICE 18 16 Protection from HARM to the patient caused by electricity 18 17 Protection from HARM to the patient caused by

29、 heat 21 18 Protection from ionizing radiation released or emitted from the ACTIVE IMPLANTABLE MEDICAL DEVICE . 21 19 Protection from unintended effects caused by the device 21 20 Protection of the device from damage caused by external defibrillators 23 21 Protection of the device from changes cause

30、d by high power electrical fields applied directly to the patient 27 22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by miscellaneous medical treatments 28 23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces . 28 24 Protection of the ACTIVE IMPLAN

31、TABLE MEDICAL DEVICE from damage caused by electrostatic discharge 33 25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by atmospheric pressure changes . 33 26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by temperature changes 34 27 Protection of t

32、he ACTIVE IMPLANTABLE MEDICAL DEVICE from electromagnetic non-ionizing radiation 34 28 Accompanying documentation 56 Annex AA (informative) Table of cross-references from 90/385/EEC to EN 45502-2-2 62 Annex BB (informative) Relationship between the subclauses of EN 45502-2-2 and the essential requir

33、ements of 90/385/EEC listed in Annex AA. 70 Annex CC (informative) Notes on EN 45502-2-2 72 Annex DD (informative) Code for describing modes of IMPLANTABLE PULSE GENERATORS . 93 Annex EE (normative) Interface circuits . 95 BS EN 45502-2-2:2008EN 45502-2-2:2008- 4 - Annex FF (informative) Selection o

34、f capacitor Cx. 99 Annex GG (normative) Calibration of injection network (Figure EE.105); Test signal of inhibition generator (Figure GG.101) 100 Annex HH (informative) Defined terms . 102 Bibliography 104 Figure 101 Measurement of CD PULSE characteristics . 12 Figure 102 Measurement of ICD OUTPUT V

35、OLTAGE . 13 Figure 103 Test set-up for measurement of electrical neutrality . 19 Figure 104 Band pass filter for a.c. leakage current measurement . 20 Figure 105 Test set up for measurement of a.c. leakage current 20 Figure 106 Test set-up for checking internal DEFIBRILLATION protection 22 Figure 10

36、7 Damped sinus DEFIBRILLATION waveform . 24 Figure 108 RCL circuit for generating a damped sinus DEFIBRILLATION waveform 24 Figure 109 Timing sequence used for DEFIBRILLATION test 25 Figure 110 Resistor network for Test 1 and Test 2 . 25 Figure 111 Test setup for truncated exponential DEFIBRILLATION

37、 waveform . 26 Figure 112 Biphasic DEFIBRILLATION waveform for Test 2 26 Figure 113 Test set up for proof of protection from high frequency currents caused by surgical equipment 28 Figure 114 Conductor current integrity test fixture 30 Figure 115 Conductor flex test fixture 31 Figure 116 Connector f

38、lex test fixture 32 Figure 117 Test signal 2 35 Figure 118 Test set-up for measurement of induced current flow . 36 Figure 119 - Common mode connection to multichannel bipolar PULSE generators 36 Figure 120 Differential mode connection to multichannel bipolar PULSE generators 37 Figure 121 Common mo

39、de connection for CARDIOVERSION/DEFIBRILLATION TERMINALS . 38 Figure 122 Differential mode connection for CARDIOVERSION/DEFIBRILLATION TERMINALS 38 Figure 123 Test set-up to check for induced malfunction 40 Figure 124 Common mode connection to multichannel bipolar PULSE generators . 41 Figure 125 Di

40、fferential mode connection to multichannel bipolar PULSE generators 41 Figure 126 Test set-up to check for induced malfunction due to voltages induced on CARDIOVERSION/DEFIBRILLATION LEADS . 42 Figure 127 Common mode connection for CARDIOVERSION/DEFIBRILLATION TERMINALS . 42 Figure 128 Differential

41、mode connection for CARDIOVERSION/DEFIBRILLATION TERMINALS 43 Figure 129 Test signal for frequencies between 10 MHz and 450 MHz . 43 Figure 130 Test set-up to check for induced malfunction at high frequency 44 Figure 131 Connection of the PULSE generator . 45 Figure 132 Test set-up to characterize p

42、erformance while subject to interference 46 Figure 133 Modulation 1 48 Figure 134 Modulation 2 (alternative) . 49 Figure 135 Test signal for frequencies between 150 kHz and 10 MHz 51 Figure 136 Test set-up to check for malfunction at high frequency . 53 Figure 137 Connection of the PULSE generator .

43、 54 Figure 138 Loop configuration for varying magnetic field test . 55 Figure CC.101 Safe exposure times for adipose/skeletal muscle tissue at various temperatures . 76 Figure CC.102 Average number of full shocks per year 78 BS EN 45502-2-2:2008EN 45502-2-2:2008- 5 - Figure CC.103 Reference test coi

44、l . 83 Figure CC.104 Amplitude at point D and C of the Tissue Interface in Annex EE (Cxselected for 5 kHz corner frequency) . 87 Figure CC.105 Test signal amplitudes for 27.3 to 27.5.3 88 Figure CC.106 Expected induced current during test according to 27.3 90 Figure EE.101 Tissue equivalent interfac

45、e circuit for current measurements 95 Figure EE.102 Tissue equivalent interface circuit to check for malfunction due to voltage induced on the sense/pace LEADS 96 Figure EE.103 Tissue equivalent interface circuit to check for malfunction due to voltages induced on the CD LEADS 97 Figure EE.104 Low p

46、ass filter used to attenuate the 500 kHz component of test signal 97 Figure EE.105 Injectionnetwork . 98 Figure FF.101 Test to check for spurious low frequency noise and to determine the value of CX99 Figure GG.101 Form of signal from a test signal generator used for determination of SENSITIVITY (SE

47、NSING THRESHOLD) and for inhibition 101 Table 101 Connection sequence 23 Table 102 Component values for resistor network shown in Figure 110 . 25 Table 103 Timing parameters of test signal for Test 2 26 Table 104 Spurious injection current limits for sense/pace TERMINALS 39 Table 105 Spurious inject

48、ion current limits for CARDIOVERSION/DEFIBRILLATION TERMINALS . 39 Table 106 Peak-to-peak amplitudes Vppin the range 16,6 Hz to 10 MHz 39 Table 107 Peak-to-peak amplitudes Vppin the range 16,6 Hz to 150 kHz (Common Mode Test) 48 Table 108 Peak-to-peak amplitudes Vppin the range 150 kHz to 10 MHz . 5

49、0 Table 109 Sinusoidally modulated magnetic field strengths 56 Table DD.101 Basic defibrillator code scheme . 93 Table DD.102 Examples of the defibrillator code 94 Table EE.101 Component values for Figure EE.101 (A) . 95 Table EE.102 Component values for Figure EE.101 (B) . 95 Table EE.103 Component values for Figure EE.102 . 96 Table EE.104 Component values for Figure EE.103 . 97 Table EE.105 Component values