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.<\/p>\n
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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 3<\/td>\n | TitlePage – Cardiac defibrillators\ufffd\u2014 Connector assembly DF-1 for implantable defibrillators\ufffd\u2014 Dim… <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | TableofContent – Contents Page <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Foreword – Foreword <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Introduction – Introduction <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Scope – 1\ufffd\ufffd\ufffd Scope NormativeReference – 2\ufffd\ufffd\ufffd Normative reference <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Clause1 – 4\ufffd\ufffd\ufffd Requirements Subclause2 – 4.1\ufffd\ufffd\ufffd General Subclause2 – 4.2\ufffd\ufffd\ufffd Defibrillator lead connector Subclause3 – 4.2.1\ufffd\ufffd\ufffd Design requirements Subclause4 – 4.2.1.1\ufffd\ufffd\ufffd Sealing mechanism <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | Subclause4 – 4.2.1.2\ufffd\ufffd\ufffd Dimensions Subclause3 – 4.2.2\ufffd\ufffd\ufffd Other requirements Subclause4 – 4.2.2.1\ufffd\ufffd\ufffd Insertion and withdrawal forces <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | Subclause4 – 4.2.2.2\ufffd\ufffd\ufffd Deformation due to set-screw and grip zone forces Subclause4 – 4.2.2.3\ufffd\ufffd\ufffd Electrical isolation requirement <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | Subclause3 – 4.2.3\ufffd\ufffd\ufffd Marking Subclause2 – 4.3\ufffd\ufffd\ufffd Defibrillator connector cavity Subclause3 – 4.3.1\ufffd\ufffd\ufffd Design requirements Subclause4 – 4.3.1.1\ufffd\ufffd\ufffd Optional seal mechanism Subclause4 – 4.3.1.2\ufffd\ufffd\ufffd Dimensions Subclause3 – 4.3.2\ufffd\ufffd\ufffd Other requirements Subclause4 – 4.3.2.1\ufffd\ufffd\ufffd Insertion and withdrawal forces Subclause4 – 4.3.2.2\ufffd\ufffd\ufffd Current-carrying requirement Subclause3 – 4.3.3\ufffd\ufffd\ufffd Marking <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | AnnexNormative – Lead connector electrical isolation test Clause1 – A.1\ufffd\ufffd\ufffd General Clause1 – A.2\ufffd\ufffd\ufffd Apparatus UntitledSubclause2 – A.2.1\ufffd\ufffd\ufffd Electrical isolation test arrangement Clause1 – A.3\ufffd\ufffd\ufffd Test samples Clause1 – A.4\ufffd\ufffd\ufffd Procedure Subclause2 – A.4.1\ufffd\ufffd\ufffd For lead connectors Subclause2 – A.4.2\ufffd\ufffd\ufffd For connector cavities if optional seals are used Subclause2 – A.4.3\ufffd\ufffd\ufffd Test cycles <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | Clause1 – A.5\ufffd\ufffd\ufffd Test results <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | AnnexNormative – Connector cavity current-carrying test Clause1 – B.1\ufffd\ufffd\ufffd General Clause1 – B.2\ufffd\ufffd\ufffd Apparatus UntitledSubclause2 – B.2.1\ufffd\ufffd\ufffd Current-carrying test pin UntitledSubclause2 – B.2.2\ufffd\ufffd\ufffd Current-carrying test arrangement Clause1 – B.3\ufffd\ufffd\ufffd Specimen preparation <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | Clause1 – B.4\ufffd\ufffd\ufffd Procedure Clause1 – B.5\ufffd\ufffd\ufffd Test results <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | AnnexInformative – Rationale for lead connector electrical isolation test Clause1 – C.1\ufffd\ufffd\ufffd Need for electrical isolation test Clause1 – C.2\ufffd\ufffd\ufffd Duration of test Clause1 – C.3\ufffd\ufffd\ufffd Test signal Clause1 – C.4\ufffd\ufffd\ufffd Leakage criteria <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | AnnexInformative – Rationale for connector cavity current-carrying test Clause1 – D.1\ufffd\ufffd\ufffd Need for current-carrying test Clause1 – D.2\ufffd\ufffd\ufffd Duration of test Clause1 – D.3\ufffd\ufffd\ufffd Test configuration Clause1 – D.4\ufffd\ufffd\ufffd Peak voltage criterion Clause1 – D.5\ufffd\ufffd\ufffd Withdrawal force <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | AnnexInformative – Rationale for requirements of this International Standard Clause1 – E.1\ufffd\ufffd\ufffd Need for a connector standard Clause1 – E.2\ufffd\ufffd\ufffd Selection of basic design concept and approach to this International Standard Clause1 – E.3\ufffd\ufffd\ufffd Guidance to this second edition <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | Clause1 – E.4\ufffd\ufffd\ufffd Specific requirement elements of this International Standard Subclause2 – E.4.1\ufffd\ufffd\ufffd Dimensions Subclause2 – E.4.2\ufffd\ufffd\ufffd Performance <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | Subclause2 – E.4.3\ufffd\ufffd\ufffd Electrical <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Cardiac defibrillators. Connector assembly DF-1 for implantable defibrillators. Dimensions and test requirements<\/b><\/p>\n |