EN 50061-1988可植入的心脏起博器的安全性.pdf

1、EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 50061 May 1988 UDC 615.817:616.12:621.313:614.8 Descriptors: Medical electrical equipment; surgical implants; pacemakers; definitions; marking; tests; performance tests English version Safety of implantable cardiac pacemakers Scurit des stimulateu

2、rs cardiaques implantables Sicherheit implantierbarer Herzschrittmacher This European Standard was ratified by CENELEC on 1 March 1988. CENELEC members are bound to comply with the requirements of the CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the s

3、tatus 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 CENELEC Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, Frenc

4、h, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to CENELEC Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgiu

5、m, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxemburg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and UnitedKingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektr

6、otechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels CENELEC 1988. Copyright reserved to all CENELEC members Ref. No. EN 50061:1988 EEN 50061:1988 2 BSI 09-1999 Brief history The European Standard 50061 was prepared byTC62 of CENELEC; it was submitted to theCENELEC members fo

7、r formal vote and acceptanceas a European Standard (EN) byCENELEC. Technical text The text of the European Standard 50061 was approved by all CENELEC members with the exception of Austria and Norway on 1 March1988. The following dates were fixed: date of announcement (doa):1988-09-01 date of latest

8、publication (dop):1989-01-01 date of withdrawal of conflicting national standards (dow):1989-01-01 Contents Page Brief history 2 0 Introduction 5 1 Scope and field of application 5 2 Terminology 5 3 Definitions 7 4 Packages and markings 9 4.1 Packages, classification 9 4.2 Markings, general requirem

9、ents 9 4.3 Shipping package 9 4.4 Storage package 9 4.5 Sterilized package 10 4.6 Pulse generators, leads and adaptors 10 5 Accompanying documents 10 5.1 General 10 5.2 Manual for the clinician 10 5.3 Registration form 12 5.4 Patients identification card 12 5.5 Explantation form 13 5.6 Individual te

10、chnical information sheet 13 6 Protection against electrical hazards 13 6.1 Effects of the discharge of a cardiac defibrillator 13 6.2 Effects of high frequency electro-surgery equipment 14 6.3 Electromagnetic compatibility 14 7 Service characteristics 14 7.1 Specific requirements 14 7.2 Test method

11、s 14 Page 8 Protection against environmental stress 15 8.1 Vibration test 15 8.2 Shock test 15 8.3 Temperature cycle 15 9 Electrical safety requirements 16 9.1 Pulse rate limit 16 9.2 Electrical neutrality of an implanted pacemaker 16 10 Measurement of pulse generator characteristics 16 10.1 General

12、 16 10.2 Measurement of pulse amplitude, pulse duration, test pulse interval and test pulserate 16 10.3 Measurement of sensitivity (sensingthreshold) 17 10.4 Measurement of input impedance 17 10.5 Measurement of escape interval 18 10.6 Measurement of sensing refractory period 20 10.7 Measurement of

13、pacing refractory period 22 10.8 Measurement of atrial-ventricular interval 23 11 Biocompatibility 23 11.1 Specific requirements 23 11.2 Test methods 23 Annex A (informative) Code for modes of pulse generator 25 Annex B (informative) Symbols 26 Annex C Method of measurement of the pulse characterist

14、ics 27 Annex D (informative) Individual technical information sheet 28 Figure 1 Simplified equivalent circuit for defibrillation test 14 Figure 2 Sequence of voltage pulses for defibrillation test 15 Figure 3 PULSE AMPLITUDE, DURATION,INTERVAL and RATE measurements 17 Figure 4 SENSITIVITY measuremen

15、t 18 Figure 5 INPUT IMPEDANCE measurement 19 Figure 6 ESCAPE INTERVAL and REFRACTORY PERIOD measurement 19 Figure 7 Initial oscilloscope display, when measuring the ESCAPE INTERVAL 20EN50061:1988 BSI 09-1999 3 Page Figure 8 Measurement of ESCAPE INTERVAL(t e ) in inhibited mode 21 Figure 9 Measureme

16、nts of ESCAPE INTERVAL(t e ) in triggered (synchronized) mode 21 Figure 10 Initial oscilloscope display when measuring sensing and pacing REFRACTORY PERIOD 21 Figure 11 Measurement of sensing REFRACTORY PERIOD in inhibited mode 22 Figure 12 Measurement of sensing REFRACTORY PERIOD in triggered (sync

17、hronous)mode 22 Figure 13 Measurement of pacing REFRACTORY PERIOD in inhibited mode 23 Figure 14 Oscilloscope display when measuringA-V interval 24 Figure C.1 Measurement of PULSE DURATION 27 Figure C.2 Measurement of PULSE AMPLITUDE 27 Figure C.3 Form of signal from a test signal generator used for

18、 the exact determination of SENSING THRESHOLD. The signal may be eitherpositive or negative 27 Table 1 16 Table 2 Basic code scheme 25 Table 3 Examples of code 254 blankEN50061:1988 BSI 09-1999 5 0 Introduction This standard was prepared by a working group of CENELEC/TC 62 “Electroradiological and E

19、lectromedical Equipment”. In preparing this standard for cardiac pacemakers, the working group was faced with a variety of problems. Pacemakers which are used nowadays differ considerably in their mode of operation and longevity. These medical devices are also subject to frequent and rapid technical

20、 development. Because of this, the standard cannot state all the necessary requirements for pacemakers. In addition, a standard for pacemakers which specifies certain constructional requirements would hamper future medical and technical development. Thus, when stipulating safety requirements for pac

21、emakers, the working group set as its objectives: It is not the purpose of this standard to specify the level of quality and reliability of individual products because the working group acknowledged the central role of clinical experience in setting required levels of reliability and performance. NO

22、TEThis standard covers besides others the mechanical safety and among the electrical hazards the safety during defibrillation. It does not cover safety aspects of electro-magnetic compatibility and high frequency electro-surgery. These aspects are under consideration at the present time. 1 Scope and

23、 field of application This standard specifies safety and other requirements exclusively for all types of wholly implantable cardiac PACEMAKERS. This standard also establishes basic terminology and definitions and includes requirements for the marking of PACEMAKERS and their packaging. In addition, m

24、inimum requirements are specified for the ability of PACEMAKERS to withstand environmental stress conditions. Appropriate test methods are given. This standard specifies the requirements for the reliable operation of PACEMAKERS only insofar as they affect safety. It does not cover the antitachyarryt

25、hmia and defibrillation functions of PACEMAKERS, nor PACEMAKERS operated by isotopic cells. 2 Terminology The following terms given in this Clause have been established to encourage common usage. Sub-clause2.4 presents the terminology particular to the modes of PULSE GENERATORS and uses the coding s

26、ystem described inAnnex A. 2.1 A-V interval (atrio-ventricular interval) the delay between an atrial PULSE or the sensing of an atrial depolarization and the subsequent ventricular PULSE or the sensing of a ventricular depolarization 2.2 V-A interval (ventricular-atrial interval) the delay between a

27、 ventricular PULSE or the sensing of a ventricular depolarization and the subsequent atrial PULSE or the sensing of an atrial depolarization 2.3 blanking period period during which a sensing function of a PULSE GENERATOR is disabled 2.4 Modes of pulse generators The definitions that follow describe

28、the mode of operation of PULSE GENERATORS. A system of coding modes is described inAnnex A. 2.4.1 atrial asynchronous mode (AOO) mode in which an atrial PULSE is provided independent of the activity of the heart. Ventricular functions and atrial sensing are disabled or absent 2.4.2 atrial inhibited

29、mode (AAI) mode where if during the ESCAPE INTERVAL the atrial sensing function detects a BEAT, then the PULSE GENERATOR suppresses atrial pacing. If the sensed atrial BEAT occurs after the ESCAPE INTERVAL, then the PULSE GENERATOR provides atrial pacing at the BASIC RATE. Ventricular functions are

30、disabled or absent 2.4.3 atrial triggered mode (AAT) mode where if during the ESCAPE INTERVAL the atrial sensing function detects a BEAT, then an atrial PULSE is produced in synchrony with the atrial BEAT (provided that the MAXIMUM TRACKING RATE is not exceeded). If the sensed atrial BEAT occurs aft

31、er the ESCAPE INTERVAL, then the PULSE GENERATOR provides atrial pacing at the BASIC RATE. Ventricular functions are disabled or absent * to improve communication between manufacturers and users, as well as among theusers themselves, by providing appropriate terminology and documentation, which woul

32、d lead to easier comparability of different pacemaker makes and models; * to increase the protection of patients against hazards caused by malfunction or by exogenous influences.EN 50061:1988 6 BSI 09-1999 2.4.4 A-V sequential, asynchronous mode(DOO) mode in which the PULSE GENERATOR provides atrial

33、 pacing at the BASIC RATE. At the specified A-V interval after each atrial PULSE, a ventricular PULSE is provided independent of the activity of the heart. Atrial and ventricular sensing functions are disabled or absent 2.4.5 A-V sequential mode with ventricular sense (inhibition) (DVI) mode in whic

34、h the atrial sensing function is disabled or absent, and the PULSE GENERATOR provides atrial pacing at the BASIC RATE. If a spontaneous ventricular BEAT is not sensed during the specified A-V interval after each atrial PULSE, a ventricular PULSE is provided 2.4.6 A-V sequential, ventricular synchron

35、ized(triggered) mode (DVT) mode in which the PULSE GENERATOR provides atrial pacing at the BASIC RATE. After each atrial PULSE, during a period equal to the set A-V interval, a ventricular PULSE is provided in synchrony with a spontaneous ventricular BEAT. If no ventricular BEAT is sensed in that pe

36、riod, then a ventricular PULSE is immediately provided. The atrial sensing function is disabled or absent 2.4.7 A-V sequential mode, with sensing and pacing in both chambers The following four modes can be distinguished: 2.4.7.1 inhibition in both channels (DDI) mode in which a spontaneous atrial BE

37、AT interrupts the PULSE GENERATORs V-A interval and starts an A-V interval without release of an atrial PULSE. A spontaneous ventricular BEAT interrupts either an A-V or V-A interval and startsanew V-A interval without release of a ventricularPULSE 2.4.7.2 triggering in the atrial channel and inhibi

38、tion in the ventricular channel (DDD) mode in which a spontaneous atrial BEAT interrupts the PULSE GENERATORs V-A interval and starts an A-V interval with release of an atrial output. A spontaneous ventricular BEAT interrupts either an A-V or V-A interval and starts a new V-A interval without releas

39、e of a ventricular PULSE 2.4.7.3 inhibition in the atrial channel and triggering in the ventricular channel (DDD) mode in which a spontaneous atrial BEAT interrupts the PULSE GENERATORs V-A interval and starts an A-V interval without release of an atrial PULSE. A spontaneous ventricular BEAT interru

40、pts the A-V interval and starts a new V-A interval with release of a ventricular PULSE 2.4.7.4 triggering in both channels (DDT) mode in which a spontaneous atrial BEAT interrupts the PULSE GENERATORs V-A interval and starts an A-V interval with release of an atrial PULSE. A spontaneous ventricular

41、BEAT interrupts that A-V interval and starts a new interval with release of a ventricular PULSE NOTEIf the A-V interval cannot be interrupted by a ventricular BEAT with a release of a ventricular PULSE as consequence, the system is said to be “committed”. 2.4.8 ventricular asynchronous mode (VOO) mo

42、de in which a ventricular PULSE is provided at the BASIC RATE, independent of the activity of the heart. Atrial functions and ventricular sensing are disabled or absent 2.4.9 ventricular inhibited mode (VVI) mode where if the ventricular sensing function detects a BEAT interval shorter than the ESCA

43、PE INTERVAL, then the PULSE GENERATOR suppresses ventricular pacing. If the sensed ventricular BEAT interval exceeds the ESCAPE INTERVAL, then the PULSE generator provides ventricular pacing at the BASIC RATE. Atrial functions are disabled or absent 2.4.10 atrial synchronized mode (VAT) mode in whic

44、h, when a spontaneous atrial BEAT is sensed, the set A-V interval commences and a ventricular PULSE is provided at the end of that interval. If the sensed atrial BEAT interval exceeds the ESCAPE INTERVAL, then the PULSE GENERATOR provides ventricular pacing at the BASIC RATE. Ventricular sensing and

45、 atrial pacing functions are disabled or absentEN50061:1988 BSI 09-1999 7 2.4.11 atrial synchronized, ventricular inhibited mode (VDD) mode in which both ventricular and atrial sensing are provided. The set A-V interval commences when a spontaneous atrial BEAT is sensed and a ventricular PULSE is pr

46、ovided at the end of that interval. If either the sensed atrial or ventricular BEAT intervals exceed the ESCAPE INTERVAL, then the PULSE GENERATOR provides ventricular pacing at the BASIC RATE. Atrial pacing is disabled or absent 2.4.12 ventricular triggered mode (VVT) mode where if the sensed ventr

47、icular BEAT interval is shorter than the ESCAPE INTERVAL, then a ventricular PULSE is provided synchronously with the spontaneous ventricular BEAT. If the sensed ventricular BEAT interval exceeds the ESCAPE INTERVAL, then ventricular pacing is provided at the BASIC RATE. Atrial functions are disable

48、d or absent NOTEThis terminology may be amended if the codes for PULSE GENERATORS are revised (seeAnnex A). 3 Definitions For the purposes of this standard the definitions given in clause3 apply. Terms used throughout this standard which have been defined in clause 3 are printed in CAPITALS. 3.1 ada

49、ptor special connector used between an otherwise incompatible PULSE GENERATOR and a LEAD 3.2 basic pulse interval the PULSE INTERVAL in absence of sensed cardiac or other electrical influence 3.3 basic rate the PULSE RATE of a PULSE GENERATOR, either atrial or ventricular, unmodified by sensed cardiac or other electrical influence 3.4 battery depletion indicator means of indicating the quantity of electricity that has been drawn from a battery during the PULSE GENERATORs service life 3.5 beat ordered spontaneous activity of