BS-6902-1-1990 EN-50061-1988.pdf
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1、BRITISH STANDARD BS 6902-1: 1990 EN 50061: 1988 Cardiac pacemakers Part 1: Specification for implantable cardiac pacemakers This European Standard EN 50061 has the status of a British Standard. UDC 615.817:616.12:621.313:614.8 BS 6902-1:1990 This British Standard was published under the authority of
2、 the Board of BSI and comes into effect on 31 May 1990 BSI 09-1999 The following BSI references relate to the work on this standard: Committee reference HCC/92 Draft for comment 86/52271 DC ISBN 0 580 18608 3 Cooperating organizations The European Committee for Electrotechnical Standardization (CENE
3、LEC), under whose supervision this European Standard was prepared, comprises the National Committees of the following countries. AustriaItaly BelgiumLuxemburg DenmarkNetherlands FinlandNorway FrancePortugal GermanySpain GreeceSweden IcelandSwitzerland IrelandUnited Kingdom Amendments issued since pu
4、blication Amd. No.Date of issueComments BS 6902-1:1990 BSI 09-1999i Contents Page Cooperating organizationsInside front cover National forewordii Brief history2 Text of EN 500615 National appendix YInside back cover National appendix ZInside back cover BS 6902-1:1990 ii BSI 09-1999 National foreword
5、 This Part of BS 6902 has been prepared under the direction of the Health Care Standards Policy Committee and is the English language version of EN 50061 “Safety of implantable cardiac pacemakers”, published by the European Committee for Electrotechnical Standardization (CENELEC). BS 6902 is intende
6、d to cover the various aspects of cardiac pacemakers, including pulse generators and connecting devices (see Additional Information below), and is published in a number of Parts. BS 6902-2 “Method of reporting the clinical performance of populations of pulse generators” was first published in 1987;
7、other Parts are in preparation. This Part of BS 6902 is closely related to the second edition of ISO 5841-1 “Implants for surgery Cardiac pacemakers Part 1: Implantable pacemakers” on which EN 50061 was based. This second edition of ISO 5841-1 was published by ISO in 1990 but, because it is not iden
8、tical to EN 50061, it cannot be implemented as a dual-numbered part of this British Standard. It has been assumed in the drafting of this British Standard that it will be used and applied by those who are appropriately qualified. Cross-references. Details of international publications/standards that
9、 are quoted in this standard and for which there is an identical or technically equivalent British Standard are given in National appendix Z. Textual errors. When adopting the text of the European Standard, the textual errors listed below were noted. They have been reported to CENELEC in a proposal
10、to amend the text of the European Standard. These amendments have been incorporated in the second edition of ISO 5841-1. In 2.4.2, the definition of the term should read: “Atrial inhibited mode (AAI): Mode in which the ventricular functions are disabled or absent. If an atrial BEAT is sensed during
11、the ESCAPE INTERVAL, then the PULSE GENERATOR suppresses atrial pacing. If no atrial BEAT is sensed during the ESCAPE INTERVAL, then the PULSE GENERATOR provides atrial pacing at the BASIC RATE.” In 2.4.3, the definition of the term should read: “Atrial triggered mode (AAT): Mode in which the ventri
12、cular functions are disabled or absent. If an atrial BEAT is sensed during the ESCAPE INTERVAL, then an atrial PULSE is provided immediately in synchrony with the atrial BEAT. If no atrial BEAT is sensed during the ESCAPE INTERVAL, then the PULSE GENERATOR provides atrial pacing at the BASIC RATE.”
13、In 2.4.5, the definition of the term should read: “A-V sequential mode with ventricular sense (inhibition) (DVI): Mode in which the atrial sensing function is disabled or absent and the PULSE GENERATOR provides atrial pacing at the BASIC RATE if no ventricular BEAT is sensed before the end of the V-
14、A interval. If no ventricular BEAT is sensed during the set A-V interval, a ventricular PULSE is provided at the end of the A-V interval. If at any time a ventricular BEAT is sensed, it starts a new V-A interval. NOTEIf the A-V interval cannot be interrupted by a ventricular beat with a consequent r
15、elease of a ventricular pulse, the system is said to be “committed”.” In 2.4.6, the definition of the term should read: “A-V sequential, ventricular synchronized (triggered) mode (DVT): Mode in which the atrial sensing function is disabled or absent and the PULSE GENERATOR provides atrial pacing at
16、the BASIC RATE if no ventricular BEAT is sensed before the end of the V-A interval. If no ventricular BEAT is sensed during the set A-V interval, a ventricular PULSE is provided at the end of the A-V interval. If at any time a ventricular BEAT is sensed, a ventricular PULSE is provided immediately a
17、nd starts a new V-A interval.” BS 6902-1:1990 BSI 09-1999iii In 2.4.7.1, the definition of the term should read: “Inhibition in both channels (DDI): Mode in which an atrial BEAT interrupts the PULSE GENERATORs atrial ESCAPE INTERVAL and starts a new atrial ESCAPE INTERVAL without release of an atria
18、l PULSE; a ventricular BEAT interrupts a ventricular ESCAPE INTERVAL and starts a new ventricular ESCAPE INTERVAL without release of a ventricular PULSE.” Additional information. It should be noted that 4.6.1 requires pulse generators to be marked with certain information. Although not stated in 4.6
19、.1, the pulse generator should also be marked with the symbol for the appropriate connector assembly. For example, this symbol could be “IS-1” together with “UNI” or “BI” to indicate respectively, whether the pulse generator requires a monopolar or bipolar connector assembly. The “IS-1” connector as
20、sembly has been proposed internationally and is the subject of draft specifications being prepared as Part 3 of ISO 5841 and as an addendum to EN 50061. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their cor
21、rect application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i to iv, the EN title page, pages 2 to 28, an inside back cover and a back cover. This standard has bee
22、n updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. iv blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 50061 May 1988 UDC 615.817:616.12:621.313:614.8 Descriptors: Medical electrical equipment; s
23、urgical implants; pacemakers; definitions; marking; tests; performance tests English version Safety of implantable cardiac pacemakers Scurit des stimulateurs cardiaques implantables Sicherheit implantierbarer Herzschrittmacher This European Standard was ratified by CENELEC on 1 March 1988. CENELEC m
24、embers are bound to comply with the requirements of the CENELEC Internal Regulations which 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 ob
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