ISO 11318:2002
Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements
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.
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TitlePage - Cardiac defibrillators— Connector assembly DF-1 for implantable defibrillators— Dim...
TableofContent - Contents Page
Foreword - Foreword
Introduction - Introduction
Scope - 1 Scope
NormativeReference - 2 Normative reference
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
Subclause4 - 4.2.1.2 Dimensions
Subclause3 - 4.2.2 Other requirements
Subclause4 - 4.2.2.1 Insertion and withdrawal forces
Subclause4 - 4.2.2.2 Deformation due to set-screw and grip zone forces
Subclause4 - 4.2.2.3 Electrical isolation requirement
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
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
Clause1 - A.5 Test results
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
Clause1 - B.4 Procedure
Clause1 - B.5 Test results
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
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
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
Clause1 - E.4 Specific requirement elements of this International Standard
Subclause2 - E.4.1 Dimensions
Subclause2 - E.4.2 Performance
Subclause2 - E.4.3 Electrical
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TitlePage - Cardiac defibrillators— Connector assembly DF-1 for implantable defibrillators— Dim...
TableofContent - Contents Page
Foreword - Foreword
Introduction - Introduction
Scope - 1 Scope
NormativeReference - 2 Normative reference
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
Subclause4 - 4.2.1.2 Dimensions
Subclause3 - 4.2.2 Other requirements
Subclause4 - 4.2.2.1 Insertion and withdrawal forces
Subclause4 - 4.2.2.2 Deformation due to set-screw and grip zone forces
Subclause4 - 4.2.2.3 Electrical isolation requirement
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
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
Clause1 - A.5 Test results
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
Clause1 - B.4 Procedure
Clause1 - B.5 Test results
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
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
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
Clause1 - E.4 Specific requirement elements of this International Standard
Subclause2 - E.4.1 Dimensions
Subclause2 - E.4.2 Performance
Subclause2 - E.4.3 Electrical