BS-7778-1994 ISO-11318-1993.pdf
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1、BRITISH STANDARD BS 7778:1994 ISO 11318: 1993 Specification for Connector assembly DF-1 for implantable cardiac defibrillators UDC 615.672:615.817:621.315.684 Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS
2、7778:1994 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 15 August 1994 BSI 11-1999 The following BSI references relate to the work on this standard: Comm
3、ittee reference HCC/92 Draft for comment 92/54286 DC ISBN 0 580 23405 3 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/92, upon which the following bodies were re
4、presented: Association of British Health-care Industries Biological Engineering Society British Cardiac Society British Pacing and Electrophysiology Group British Surgical Trades Association Department of Health Electricity Association Institute of Physical Sciences in Medicine (IPSM) Institution of
5、 Electrical Engineers Medical Research Council Ministry of Defence National Heart and Lung Institute National Radiological Protection Board Royal College of Physicians of London Society of Cardiothoracic Surgeons of Great Britain and Ireland Amendments issued since publication Amd. No.DateComments L
6、icensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7778:1994 BSI 11-1999i Contents Page Committees responsibleInside front cover National forewordii 1Scope1 2Normative reference1 3Definitions1 4Requirements2 Ann
7、ex A (normative) Lead connector electrical isolation test7 Annex B (normative) Connector cavity current-carrying test11 Annex C (informative) Rationale for lead connector electrical isolation test13 Annex D (informative) Rationale for connector cavity current-carrying test14 Annex E (informative) Ra
8、tionale for requirements of Standard14 Figure 1 DF-1 lead connector3 Figure 2 DF-1 lead connector GO gauge4 Figure 3 Marking4 Figure 4 DF-1 connector cavity5 Figure 5 DF-1 connector cavity GO gauge6 Figure A.1 Electrical isolation test arrangement8 Figure A.2 Test signal9 Figure A.3 Test cavity10 Fi
9、gure A.4 Impedance test pin10 Figure A.5 Current leakage waveform11 Figure B.1 Current-carrying test pin12 Figure B.2 Current-carrying test arrangement12 Figure B.3 Current-carrying test waveform13 List of referencesInside back cover Licensed Copy: London South Bank University, London South Bank Uni
10、versity, Fri Dec 08 10:29:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7778:1994 ii BSI 11-1999 National foreword This British Standard has been prepared under the direction of the Health Care Standards Policy Committee. It is identical with ISO 11318:1993 Cardiac defibrillators Connector assemb
11、ly for implantable defibrillators Dimensional and test requirements, published by the International Organization for Standardization (ISO). The connector assembly, DF-1, has been specified in order to provide interchangeability between implantable defibrillator leads and defibrillator pulse generato
12、rs from different manufacturers. The safety, reliability and function of a particular connector part are the responsibility of the manufacturer. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct app
13、lication. Compliance with a British Standard does not of itself confer immunity from legal obligations. Cross-references International StandardCorresponding British Standard ISO 7436:1983BS EN 27436:1992 Slotted set screws with cup point (Identical) Summary of pages This document comprises a front c
14、over, an inside front cover, pages i and ii, pages 1 to 16, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: London South Bank U
15、niversity, London South Bank University, Fri Dec 08 10:29:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7778:1994 BSI 11-19991 1 Scope This International Standard specifies a unipolar connector assembly, DF-1, intended for use in connecting implantable defibrillator leads to implantable defibrill
16、ator generators which do not produce more than 1 kV/50 A peak output. Essential dimensions and performance requirements are specified along with test methods. This International Standard does not specify other connector features such as fastening means and material. Nor does it address all aspects o
17、f functional compatibility or reliability of different implantable defibrillator leads and implantable defibrillator generators assembled into an implantable defibrillator system. NOTE 1Defibrillator connector systems not conforming to this International Standard may be safe and reliable, and may ha
18、ve clinical advantages. 2 Normative reference The following standard contains provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the edition indicated was valid. All standards are subject to revision, and parties to agr
19、eements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the standard indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 7436:1983, Slotted set screws with cup point. 3 De
20、finitions For the purposes of this International Standard, the following definitions apply. 3.1 connector assembly assembly, consisting of a lead connector and a connector cavity, for the electrical and mechanical connection to a defibrillator generator 3.2 lead connector that part of the connector
21、assembly which is inserted into the connector cavity 3.3 connector cavity that part of the connector assembly which is part of the defibrillator generator 3.4 sealing mechanism circumferential barrier intended to maintain the electrical insulation between electrically isolated parts of the connector
22、 assembly 3.5 seal zone surface in the connector cavity and on the lead connector on which one or more seals are intended to bear 3.6 sealing mechanism zone portion of the lead connector (and optionally the connector cavity) in which the sealing mechanism is permitted 3.7 connector cavity GO gauge t
23、ool for assessing the ability of a connector cavity to accept a lead connector of maximum size 3.8 lead connector GO gauge tool for assessing the ability of a lead connector to be inserted into a connector cavity of minimum size 3.9 lead connector pin conductive element of the lead connector intende
24、d to contact the connector cavity conductive element 3.10 defibrillator system assembly consisting of defibrillator generator and a defibrillator lead(s) 3.11 defibrillator lead means of electrically connecting a defibrillator generator to the patient 3.12 defibrillator generator portion of the defi
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