BS ISO 11318:2002
$142.49
Cardiac defibrillators. Connector assembly DF-1 for implantable defibrillators. Dimensions and test requirements
| Published By | Publication Date | Number of Pages |
| BSI | 2002 | 30 |
This International Standard specifies a unipolar connector assembly, DF-1, intended for use in connecting implantable defibrillator leads to implantable defibrillator generators that do not produce more than 1 kV/50 A 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 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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 3 | TitlePage – Cardiac defibrillators�— Connector assembly DF-1 for implantable defibrillators�— Dim… |
| 5 | TableofContent – Contents Page |
| 6 | Foreword – Foreword |
| 7 | Introduction – Introduction |
| 9 | Scope – 1��� Scope NormativeReference – 2��� Normative reference |
| 10 | Clause1 – 4��� Requirements Subclause2 – 4.1��� General Subclause2 – 4.2��� Defibrillator lead connector Subclause3 – 4.2.1��� Design requirements Subclause4 – 4.2.1.1��� Sealing mechanism |
| 11 | Subclause4 – 4.2.1.2��� Dimensions Subclause3 – 4.2.2��� Other requirements Subclause4 – 4.2.2.1��� Insertion and withdrawal forces |
| 12 | Subclause4 – 4.2.2.2��� Deformation due to set-screw and grip zone forces Subclause4 – 4.2.2.3��� Electrical isolation requirement |
| 13 | Subclause3 – 4.2.3��� Marking Subclause2 – 4.3��� Defibrillator connector cavity Subclause3 – 4.3.1��� Design requirements Subclause4 – 4.3.1.1��� Optional seal mechanism Subclause4 – 4.3.1.2��� Dimensions Subclause3 – 4.3.2��� Other requirements Subclause4 – 4.3.2.1��� Insertion and withdrawal forces Subclause4 – 4.3.2.2��� Current-carrying requirement Subclause3 – 4.3.3��� Marking |
| 16 | AnnexNormative – Lead connector electrical isolation test Clause1 – A.1��� General Clause1 – A.2��� Apparatus UntitledSubclause2 – A.2.1��� Electrical isolation test arrangement Clause1 – A.3��� Test samples Clause1 – A.4��� Procedure Subclause2 – A.4.1��� For lead connectors Subclause2 – A.4.2��� For connector cavities if optional seals are used Subclause2 – A.4.3��� Test cycles |
| 17 | Clause1 – A.5��� Test results |
| 21 | AnnexNormative – Connector cavity current-carrying test Clause1 – B.1��� General Clause1 – B.2��� Apparatus UntitledSubclause2 – B.2.1��� Current-carrying test pin UntitledSubclause2 – B.2.2��� Current-carrying test arrangement Clause1 – B.3��� Specimen preparation |
| 23 | Clause1 – B.4��� Procedure Clause1 – B.5��� Test results |
| 24 | AnnexInformative – Rationale for lead connector electrical isolation test Clause1 – C.1��� Need for electrical isolation test Clause1 – C.2��� Duration of test Clause1 – C.3��� Test signal Clause1 – C.4��� Leakage criteria |
| 26 | AnnexInformative – Rationale for connector cavity current-carrying test Clause1 – D.1��� Need for current-carrying test Clause1 – D.2��� Duration of test Clause1 – D.3��� Test configuration Clause1 – D.4��� Peak voltage criterion Clause1 – D.5��� Withdrawal force |
| 27 | AnnexInformative – Rationale for requirements of this International Standard Clause1 – E.1��� Need for a connector standard Clause1 – E.2��� Selection of basic design concept and approach to this International Standard Clause1 – E.3��� Guidance to this second edition |
| 28 | Clause1 – E.4��� Specific requirement elements of this International Standard Subclause2 – E.4.1��� Dimensions Subclause2 – E.4.2��� Performance |
| 29 | Subclause2 – E.4.3��� Electrical |
