BS EN 50077-1993 Specification for low profile connectors (IS-1) for implantable pacemakers《心脏起搏器 第3部分 可植入式起搏器用薄断面连接器》.pdf

1、BRITISH STANDARD BS EN 50077:1993 Specification for Low profile connectors(IS-1) for implantable pacemakers The European Standard EN50077:1993 has the status of a British Standard UDC 615.817:621.315.683BSEN50077:1993 This British Standard, having been prepared under the directionof the Health Care

2、Standards Policy Committee, waspublished under the authorityof the Standards Boardand comes into effect on 15December1993 BSI 12-1999 The following BSI references relate to the work on this standard: Committee reference HCC/92 Draft for comment 89/53309 DC ISBN 0 580 21857 0 Cooperating organization

3、s The European Committee for Electrotechnical Standardization(CENELEC), under whose supervision this European Standard was prepared, comprises the national committees of the following countries: Austria Italy Belgium Luxembourg Denmark Netherlands Finland Norway France Portugal Germany Spain Greece

4、Sweden Iceland Switzerland Ireland United Kingdom Amendments issued since publication Amd. No. Date CommentsBSEN50077:1993 BSI 12-1999 i Contents Page Cooperating organizations Inside front cover National foreword ii Foreword 2 Text of EN50077 3 National annex NA (informative) Committees responsible

5、 Inside back cover National annex NB (informative) Cross-references Inside back coverBSEN50077:1993 ii BSI 12-1999 National foreword This BritishStandard has been prepared under the direction of the Health Care Standards Policy Committee. It is the English language version of EN50077:1993 incorporat

6、ing corrigendum November1993 Low profile connector for implantable cardiac pacemakers, published by the European Committee for Electrotechnical Standardization(CENELEC). This standard is technically equivalent to ISO5841-3:1992 Cardiac pacemakers Part3: Low profile connectors(IS-1) for implantable p

7、acemakers which was published by the International Organization for Standardization(ISO). NOTEISO5841-2 has been implemented in the United Kingdom as BS6902-2. Textual error. When adopting the text of the European Standard, the textual error given below was discovered. It has been marked in the text

8、 and has been reported to CENELEC in a proposal to amend the text of the European Standard. In the foreword the references to EN46003-1 should be read as EN45502-1 (inpreparation). Typographical error. InB.3.2 the reference to subclause4.1.2.1 and4.2.2.2 should be read as4.1.2.1 and4.2.2.1. A Britis

9、h Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front

10、cover, an inside front cover, pagesi andii, theEN title page, pages2 to10, 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.EUROPEAN STANDARD NO

11、RME EUROPENNE EUROPISCHE NORM EN50077 June1993 UDC 615.817:621.315.683 Incorporates corrigendum November1993. Descriptors: Medical electrical equipment, surgical implants, cardiac pacemakers, leads, low-profile connectors, definitions, design, performances, markings, requirements, tests English vers

12、ion Low-profile connector for implantable cardiac pacemakers Connecteur bas profil pour stimulateurs cardiaques implantables Kleiner Profilstecker fr implantierbare Herzschrittmacher This European Standard was approved by CENELEC on24 March1992. CENELEC members are bound to comply with the CEN/CENEL

13、EC 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 obtained on application to the Central Secretariat or to any CE

14、NELEC member. This European Standard exists in three official versions(English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions

15、 CENELEC members are the national electrotechnical committees of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardiz

16、ation Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1993 Copyright reserved to CENELEC members Ref.No.EN50077:1993EEN50077:1993 BSI 12-1999 2 Foreword This standard was prepared by CENELEC TC6

17、2 WG “Active Implants” in parallel with the Joint IEC/ISO International Pacemaker Standards Working Group (ISO/TC150/SC2/WG2 and IEC/SC62D/WG6). The document was submitted to the CENELEC members for formal vote in June1991 and was approved by CENELEC as EN50077 on24 March1992. The following dates we

18、re fixed: This European Standard is identical to ISO5841-3 except for minor editorial corrections. The scope of ISO5841-3 warns that the standard does not provide a complete specification for a safe working connector pair. In particular, no minimum disconnecting force is specified for the mated conn

19、ector pair. This, and other essential requirements, are under consideration by the CEN/CENELEC JWG “Active Implantable Medical Devices” and will be covered by clauses of EN46003-1 1) (in preparation), a harmonized standard relating to the European Council Directive relating to active implantable med

20、ical devices of20June1990(90/385/EEC). Annex A gives a test method for determining the electrical separation provided by the mated lead connector, and is an integral part of this standard. Annex B provides an explanatory rationale for therequirements of this standard, and is an informative annex. It

21、 is recommended that this annex be read before using the standard, so that the user may be informed about the limitations in the provisions of this standard. Contents Page Foreword 2 0 Introduction 3 1 Scope 3 2 Normative references 3 3 Definitions 3 4 Requirements 4 4.1 Lead connector 4 4.1.1 Desig

22、n requirements 4 4.1.2 Performance requirements 5 4.1.3 Marking 6 4.2 Connector cavity 7 4.2.1 Design requirements 7 4.2.2 Performance requirements 7 4.2.3 Marking 7 Annex A (normative) Lead connector electricalseparation test method 8 A.1 Specimen preparation 8 A.2 Equipment 8 A.3 Procedure 8 Annex

23、 B (informative) Rationale 9 B.1 Need for a connector standard 9 B.2 Selection of the basic design concept and approach to the standard 9 B.3 Specific clauses of the standard 9 B.3.1 Clause1 (Scope) 9 B.3.2 Clause4 (Requirements) 9 Figure 1 Lead connector 4 Figure 2 Lead connector go-gauge 5 Figure

24、3 Symbols for designating connectorassembly parts 6 Figure 4 Connector cavity 6 Figure 5 Connector cavity go-gauge 7 Figure A.1 Lead connector electricalseparationtest cavity 8 latest date of publication ofan identical national standard (dop) 1993-12-01 latest date of withdrawal ofconflicting nation

25、al standards (dow) 1993-12-01 1) Seenational foreword for details of textual error.EN50077:1993 BSI 12-1999 3 0 Introduction The development of this standard was prompted by the concern of clinicians over the variety of apparently similar but incompatible pacing leads of the low-profile in-line type

26、Because the major diameter of these lead connectors is3,2mm, they are generally referred to as“3,2mm” leads.) The purpose of this European Standard is to specify a standard connector assembly, IS-1, to allow leads and pulse generators from different manufacturers to be interchangeable. The overall

27、 safety, reliability and function of particular connector parts remain the responsibility of the manufacturers. 1 Scope This European standard specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pulse generators. Essential dimensions and performance requir

28、ements are specified, together with appropriate test methods. However, this standard does not address all aspects of the functional compatibility and reliability of different leads and pulse generators assembled into a pacemaker system: in particular, this standard does not specify certain essential

29、 features, such as the means of fastening the connector assembly, or the materials of construction. WARNING. The connector cavity specified in this standard is not to be used with an implantable device if that device is capable of introducing dangerous non-pacing signals(e.g.defibrillation signals)

30、through an IS-1 connector. This European standard supplements EN50061 only for those pacemaker components which are claimed by their labelling to be fitted with an IS-1 connector assembly part. It does not replace any requirement in EN50061 regarding leads. 2 Normative references This European stand

31、ard incorporates, by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of these publications apply to this E

32、uropean standard only when incorporated in it by amendment or revision. For undated references, the latest edition of the publication referred to applies. EN50061, Safety of implantable cardiac pacemakers. NOTEEN50061 is technically equivalent to ISO5841-1: Cardiac Pacemakers Part1: Implantable pace

33、makers. 3 Definitions For the purposes of this standard, the definitions of EN50061 and the following definitions apply. 3.1 connector assembly assembly consisting of a lead connector and a connector cavity for the electrical and mechanical connection of a lead to a pulse generator 3.2 lead connecto

34、r that part of the connector assembly attached to the lead(SeeFigure 1.) 3.3 connector cavity that part of the connector assembly attached to the pulse generator(SeeFigure 4.) 3.4 sealing ring circumferential barrier intended to maintain the electrical separation between electrically isolated parts

35、of the connector assembly 3.5 seal zone surface in the connector cavity on which one or more sealing rings on the lead connector are intended to bear 3.6 connector cavity go-gauge tool for assessing the ability of a connector cavity to accept a lead connector of maximum size (SeeFigure 5.) 3.7 lead

36、connector go-gauge tool for assessing the ability of a lead connector to be inserted into a connector cavity of minimum size (SeeFigure 2.) 3.8 lead connector ring for a bipolar lead, the outermost conductive element of the lead connector intended to contact the outermost conductive element of the c

37、onnector cavity 3.9 lead connector pin 1) For a bipolar lead, the innermost conductive element of the lead connector intended to make electrical contact with the innermost conductive element of the connector cavity.EN50077:1993 4 BSI 12-1999 2) For a unipolar lead, the conductive element of the lead

38、 connector intended to contact the innermost(or only) connector cavity conductive element. 3.10 ring set-screw set-screw in a bipolar connector cavity which is intended to contact the lead connector ring 4 Requirements The test methods provided for the performance requirements are type(qualification

39、) tests. Equivalent test methods may be used. However, in the event of a dispute, the test methods described in this standard shall be used. 4.1 Lead connector 4.1.1 Design requirements 4.1.1.1 Sealing rings At least one sealing ring shall be provided in each of two sealing ring zones on the lead co

40、nnector and be located as specified in Figure 1. 4.1.1.2 Dimensions The lead connector shall have the dimensions specified in Figure 1. Figure 1 Lead connectorEN50077:1993 BSI 12-1999 5 4.1.1.3 Lead connector/electrode continuity and function The lead connector pin shall be in electrical continuity

41、with the stimulating electrode of the lead. The lead connector ring, if utilized, shall be in electrical continuity with an electrode capable of pacing and electrogram-sensing functions other than the electrode which is in electrical continuity with the lead connector pin. 4.1.2 Performance requirem

42、ents 4.1.2.1 Maximum insertion and withdrawal force of lead connector go-gauge As shipped, the lead connector shall fit completely into the lead connector go-gauge specified in Figure 2 with a maximum insertion and withdrawal force of14N. 4.1.2.2 Electrical separation between conducting parts The mi

43、nimum electrical impedance between conductive elements intended to be electrically separated by the sealing rings shall be50k7. Compliance shall be determined by the test method described in Annex A. 4.1.2.3 Deformation due to set-screw A securing set-screw shall not deform the lead connector to the

44、 extent that insertion and withdrawal forces become excessive. Compliance shall be determined as follows. The lead connector is inserted into a test cavity which conforms to Figure 4. The lead connector is fastened in the centre of zones designated as6 and7 (seeFigure 4) by two M2 set-screws, with c

45、up points, to a torque of0,15Nm 0,01Nm. The set-screws are then retracted. The lead connector withdrawal force shall not exceed14N and the lead connector shall subsequently comply with the insertion and withdrawal force requirement as specified in4.1.2.1. 4.1.2.4 Effect on a unipolar lead connector

46、of the ring set-screw of a bipolar connector cavity The ring set-screw shall not affect the function of a unipolar lead. Compliance shall be determined as follows. Apply the test described in4.1.2.3 and then check that the electrical function of the lead has been unaffected. NOTESurface roughness, R

47、 a , on all bore diameters shall be. Material: Polymethylmethacrylate. Dimensions in millimetres Figure 2 Lead connector go-gaugeEN50077:1993 6 BSI 12-1999 4.1.3 Marking Marking shall be permanent and legible. The lead connector shall be marked with the symbol “IS-1” as shown in Figure 3, with the s

48、ize appropriate for the connector assembly part being marked. For unipolar lead connectors, each connector shall be marked with the symbol “UNI”; for bipolar lead connectors, each connector shall be marked with the symbol “BI”, as shown in Figure 3. An optional index mark may be provided as an align

49、ment aid. If such a mark is provided, it shall be located at the zone designated as3 in Figure 1. Figure 3 Symbols for designating connectorassembly parts Figure 4 Connector cavityEN50077:1993 BSI 12-1999 7 4.2 Connector cavity 4.2.1 Design requirements The connector cavity dimensions shall be asspecified in Figure 4. 4.2.2 Performance requirements 4.2.2.1 Insertion: connector go-gauge The connector cavity shall accept the go-gauge specified in Figure 5. 4.2.2.2 Maximum insertion force: gauge pin In the zone designated as5 in Figure 4,