1、BRITISH STANDARD BS ISO 11318:2002 Cardiac defibrillators Connector assembly DF-1 for implantable defibrillators Dimensions and test requirements ICS 11.040.40 BS ISO 11318:2002 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy C
2、ommittee, was published under the authority of the Standards Policy and Strategy Committee on 29 November 2002 BSI 29 November 2002 ISBN 0 580 40847 7 National foreword This British Standard reproduces verbatim ISO 11318:2002 and implements it as the UK national standard. It supersedes BS 7778:1994
3、which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/150, Implants for surgery, to Subcommittee CH/150/6, Active implants, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secret
4、ary. Cross-references The British Standards which implement international publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of Bri
5、tish Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; prese
6、nt to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an i
7、nside front cover, the ISO title page, pages ii to v, a blank page, pages 1 to 21 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsINTERNATIONAL STANDARD ISO 11318 Second edition
8、 2002-08-01 Reference number ISO 11318:2002(E) Cardiac defibrillators Connector assembly DF-1 for implantable defibrillators Dimensions and test requirements Dfibrillateurs cardiaques Ensemble connecteur DF-1 pour dfibrillateurs implantables Dimensions et exigences dessaiBSISO11318:2002BSISO11318:20
9、02iiISO 13112002:8)E( ISO 2002 r llAithgs reservde iii Contents Page 1 Scope . 1 2 Normative reference . 1 3 Terms and definitions 1 4 Requirements . 2 Annexes A Lead connector electrical isolation test. 8 B Connector cavity current-carrying test 13 C Rationale for lead connector electrical isolatio
10、n test. 16 D Rationale for connector cavity current-carrying test 18 E Rationale for requirements of this International Standard. 19 BSISO11318:2002iiiISO :81311(2002)E vi ISO 2002 Ar llithgr seresvde Foreword ISO (the International Organization for Standardization) is a worldwide federation of nati
11、onal standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. Internat
12、ional organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the ru
13、les given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the po
14、ssibility that some of the elements of this International Standard may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO11318 was prepared by Technical Committee ISO/TC150, Implants for surgery, Subcommittee S
15、C 6, Active implants. This second edition cancels and replaces the first edition (ISO 11318:1993), which has been technically revised. Annexes A and B form a normative part of this International Standard. Annexes C, D and E are for information only. BSISO11318:2002ivISO 13112002:8)E( ISO 2002 r llAi
16、thgs reservde v Introduction The purpose of this International Standard is to specify a standard connector assembly, DF-1, to provide interchangeability between implantable defibrillator leads and defibrillator pulse generators from different manufacturers. The safety, reliability and function of a
17、particular connector part are the responsibility of the manufacturer. Defibrillator connector systems not conforming to this International Standard may be safe and reliable, and may have clinical advantages. BSISO11318:2002vANRETNIITOTS LANDNADRA ISO 13112002:8)E( ISO 2002 r llAithgs reservde 1 Card
18、iac defibrillators Connector assembly DF-1 for implantable defibrillators Dimensions and test requirements 1 Scope This International Standard specifies a unipolar connector assembly, DF-1, intended for use in connecting implantable defibrillator leads to implantable defibrillator generators that do
19、 not produce more than peak output. Essential dimensions and performance requirements related to connector fit are specified, along with test methods. This International Standard does not specify other connector features such as fastening means and material. This International Standard is applicable
20、 to the form and fit of the connector assembly, and does not address all aspects of functional compatibility, system performance, or reliability of different implantable defibrillator leads and implantable defibrillator generator assemblies. 2 Normative reference The following normative document con
21、tains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, this publication do not apply. However, parties to agreements based on this International Standard are encouraged to investig
22、ate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 7436:1983, Slotted se
23、t screws with cup point 3 Terms and definitions For the purposes of this International Standard, the following terms and 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 generato
24、r 3.2 lead connector that part of the connector assembly that is inserted into the connector cavity 3.3 connector cavity that part of the connector assembly that is part of the defibrillator generator 3.4 sealing mechanism circumferential barrier intended to maintain the electrical insulation betwee
25、n electrically isolated parts of the connector 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 1 kV/50 A BSISO11318:20021ISO :81311(2002)E 2 ISO 2002 Ar llithgr seresvde 3.6 sealing mechanism zone portion of the lead co
26、nnector (and optionally the connector cavity) in which the sealing mechanism is permitted 3.7 connector cavity GO gauge tool 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
27、 inserted into a connector cavity of minimum size 3.9 lead connector pin conductive element of the lead connector intended 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 m
28、eans of electrically connecting a defibrillator generator to the patient 3.12 defibrillator generator portion of the defibrillator system that includes the power supply and electronic circuits 3.13 grip zone area of lead connector that is provided for grasping the lead connector during insertion and
29、 withdrawal 3.14 connector contact current-carrying interface between the connector cavity and the lead connector 4 Requirements 4.1 General The test methods provided for the requirements that follow are type (qualification) tests. Equivalent test methods may be used. However, in the event of a disp
30、ute, the test methods described in this International Standard shall be used. The tests shall be conducted at room temperature unless otherwise specified. 4.2 Defibrillator lead connector 4.2.1 Design requirements 4.2.1.1 Sealing mechanism At least one seal shall be provided on the lead connector an
31、d shall be located as specified in Figure 1. BSISO11318:20022ISO 13112002:8)E( ISO 2002 r llAithgs reservde 3 4.2.1.2 Dimensions The lead connector shall have the dimensions specified in Figure 1. 4.2.2 Other requirements 4.2.2.1 Insertion and withdrawal forces As shipped, the lead connector shall f
32、it completely into the lead connector GO gauge specified in Figure 2. Neither the insertion force nor the withdrawal force shall exceed . After insertion and withdrawal, the lead connector shall comply with Figure 1. Dimensions in millimetres Key 1 Sealing mechanism zone 2S e a l z o n e 3G r i p z
33、o n e a Sealing rings as shown are for illustration only and are not restricted as to shape, size or number. b The two diameters according to zone 1 and 2 shall be concentric within to datum A. c For optional seal mechanism in connector cavity; applies to this zone. d Maximum length of rigid area. e
34、 Minimum length of rigid area. f applies to this zone only. g Length at the manufacturers discretion, max. diameter . h The diameters of the soft sections of the lead may be determined as the mean value of three measurements taken at locations oriented approximately apart around the principal axis o
35、f the lead connector. Figure 1 DF-1 lead connector 0,13 mm 3,23 0,1 3,23 +0,1 0,2 4,1 mm 120 14 N BSISO11318:20023ISO :81311(2002)E 4 ISO 2002 Ar llithgr seresvde 4.2.2.2 Deformation due to set-screw and grip zone forces When tested as described below, the forces imposed by the securing mechanism sh
36、all not cause the lead connector to be deformed to the extent that it does not comply with 4.2.2.1. Compliance shall be determined as follows. Insert the lead connector into a lead connector GO gauge complying with Figure 2. Fasten the lead connector in the centre of zone 1 (see Figure 2) with an M2
37、 setscrew with cup point complying with ISO 7436, applying a torque of . Apply an axial withdrawal force of for to the grip zone and then retract the set-screw. Check that the lead connector still complies with 4.2.2.1. 4.2.2.3 Electrical isolation requirement The lead connector shall provide electr
38、ical isolation between the lead connector pin and the surrounding fluid. Compliance shall be determined as described in annex A. Dimensions in millimetres Surface roughness in micrometres Key 1 Vent hole 2 Set-screw contact zone 3 Epoxy material a Break sharp corners. Figure 2 DF-1 lead connector GO
39、 gauge (0,15 0,01) Nm (15 1) N (60 10) s BSISO11318:20024ISO 13112002:8)E( ISO 2002 r llAithgs reservde 5 4.2.3 Marking Marking shall be permanent and legible. The lead connector shall be marked with the symbol “DF-1” as depicted in Figure 3. 4.3 Defibrillator connector cavity 4.3.1 Design requireme
40、nts 4.3.1.1 Optional seal mechanism If provided, seal(s) shall be located at the zone specified in Figure 4 and shall provide electrical isolation. Compliance shall be determined as described in annex A. 4.3.1.2 Dimensions The connector cavity dimensions shall be as specified in Figure 4. 4.3.2 Othe
41、r requirements 4.3.2.1 Insertion and withdrawal forces As shipped, the connector cavity shall accept the GO gauge specified in Figure 5. Neither the insertion force nor the withdrawal force shall exceed . After insertion and withdrawal, the connector cavity shall comply with Figure 4. 4.3.2.2 Curren
42、t-carrying requirement The connector contact shall be capable of carrying current. Compliance shall be determined as described in annex B. 4.3.3 Marking The defibrillator generator shall be marked with the symbol “DF-1” as depicted in Figure 3. Figure 3 Marking for defibrillator lead connector and g
43、enerator 9N BSISO11318:20025ISO :81311(2002)E 6 ISO 2002 Ar llithgr seresvde Dimensions in millimetres unless otherwise indicated Key 1 Optional sealing mechanism zone 2S e a l z o n e 3 Lead connector pin contact zone a The diameter of this area shall meet the requirements of 4.3.2.1. b Specified d
44、iameter applies to this zone only. c applies to this zone only. d applies to this zone only. e allowed in this zone. f The bore centreline shall be from the defibrillator generator at any point beyond the open end of the connector cavity. Figure 4 DF-1 connector cavity 1,31 +0,1 0 1,31 min. 3,43 min
45、. 2,05 mm BSISO11318:20026ISO 13112002:8)E( ISO 2002 r llAithgs reservde 7 Dimensions in millimetres Surface roughness in micrometers Key 1 Knurled handle Figure 5 DF-1 connector cavity GO gauge BSISO11318:20027ISO :81311(2002)E 8 ISO 2002 Ar llithgr seresvde Annex A (normative) Lead connector elect
46、rical isolation test A.1 General This is a type (qualification) test and is not intended to be used as a routine production test. The manufacturer may use equivalent test methods; however in a dispute, this test method shall be used. A.2 Apparatus A.2.1 Electrical isolation test arrangement, shown i
47、n Figure A.1. The test arrangement shall conform to the following criteria. a) The test signal shall have a truncated exponential waveform (as an example, see Figure A.2). b) The test signal shall have a rise time from to of the peak voltage and the shall be . c) The test signal shall have a duratio
48、n of , and there shall be a interval between pulses. d) The test pulse shall be in peak amplitude, and shall be at after the peak amplitude. e) The reference electrode with an area of shall be immersed in a saline solution at a distance not less than , and not more than , from the lead connector und
49、er test. A.3 Test samples The samples intended for test shall be in the condition as shipped to the customer. A.4 Procedure A.4.1 For lead connectors Assemble the lead connector and test cavity (see Figure A.3) while they are submerged in a saline solution, ensuring that the lead connector axis is offset by and that no bubbles of air are trapped. Allow the assembly to remain immersed in the saline sol
