EN 50061-1988可植入的心脏起博器的安全性.pdf
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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
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