AAMI 27186 2010
$162.84
ANSI/AAMI/ISO 27186:2010 – Active implantable medical devices-Four-pole connector system for implantable cardiac rhythm management devices-Dimensional and test requirements
| Published By | Publication Date | Number of Pages |
| AAMI | 2010 | 99 |
This includes all essential design and performance requirements for two types of four-pole electrical connectors, low voltage and high/low voltage, intended for use on implantable cardiac pacemakers and implantable defibrillators.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 27186:2010, Active implantable medical devices – Four-pole connector system for implantable cardiac rhythm management devices – Dimensional and test requirements |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 9 | Background of ANSI/AAMI adoption of ISO 27186:2010 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions |
| 17 | 4 Requirements 4.1 General |
| 18 | 4.2 Lead connector physical requirements 4.2.1 Dimensions 4.2.1.1 General 4.2.1.2 Total axial pin movement, M 4.2.1.3 Pristine contact zones 4.2.1.4 Pristine seal zones 4.2.1.5 Lead connector body |
| 19 | 4.2.1.6 Strain relief zone 4.2.1.7 Grip zone 4.2.1.8 Chamfer zone 4.2.1.9 Transition zone 4.2.1.10 Insertion indicator zone |
| 20 | 4.2.1.11 Pin pristine contact zone |
| 22 | 4.2.2 Materials 4.2.2.1 Contact materials 4.2.2.2 Seal surface material 4.2.3 Lead connector electrical connections 4.2.4 Lead marking 4.2.4.1 Marking symbol 4.2.4.2 Marking location 4.2.4.3 Marking orientation |
| 24 | 4.2.5 Lead package labels and literature 4.3 Lead connector functional requirements 4.3.1 Functional check 4.3.1.1 Test method |
| 25 | 4.3.1.2 Requirement 4.3.2 Tensile loads 4.3.2.1 Test method 4.3.2.2 Requirement 4.3.3 Deformation due to pin contact forces 4.3.3.1 Test method 4.3.3.2 Requirement |
| 26 | 4.3.4 Deformation due to ring contact forces 4.3.4.1 Test method 4.3.4.2 Requirement |
| 27 | 4.3.5 Seal zone requirement 4.3.6 Electrical isolation requirement 4.3.7 Dielectric strength requirement 4.3.8 Current-carrying requirement 4.3.9 Corrosion/environmental 4.4 Connector cavity physical requirements 4.4.1 Dimensions 4.4.1.1 General 4.4.1.2 Functional contact zones 4.4.1.3 Functional seal zones 4.4.1.4 Material |
| 30 | 4.4.2 Connector cavity electrical connections 4.4.3 Connector cavity/pulse generator marking |
| 31 | 4.4.4 Pulse generator labels and literature 4.5 Connector cavity functional requirements 4.5.1 Insertion force 4.5.1.1 Test method 4.5.1.2 Requirement |
| 32 | 4.5.2 Retention force 4.5.2.1 Test method |
| 33 | 4.5.2.2 Requirement 4.5.3 Withdrawal force 4.5.3.1 Test method 4.5.3.2 Requirement 4.5.4 Ring contact load 4.5.4.1 Applicability |
| 34 | 4.5.4.2 Test method 4.5.4.3 Requirement 4.5.5 Seal zone requirement 4.5.6 Electrical isolation requirement 4.5.7 Dielectric strength requirement 4.5.8 Current-carrying requirement (high voltage connector cavity) 4.5.9 Contact resistance/stability |
| 35 | Annex A Electrical isolation test A.1 General A.1.1 Purpose A.1.2 Specimen preparation A.1.3 Saline solution A.1.4 Reference electrode A.1.5 Test signal A.2 Lead connector test A.2.1 Purpose A.2.2 Preconditioning |
| 36 | A.2.3 Test method A.2.4 Acceptance criteria |
| 37 | A.3 Connector cavity test A.3.1 Purpose A.3.2 Test pin |
| 39 | A.3.3 Preconditioning A.3.4 Test method A.3.5 Acceptance criteria |
| 40 | Annex B Rationale for Annex A B.1 Isolation impedance B.2 Mechanical load |
| 41 | B.3 Test combinations B.4 Connector cavity isolation test pin |
| 42 | Annex C Dielectric strength test C.1 General C.1.1 Purpose C.1.2 Specimen preparation C.1.3 Reagent and materials C.1.4 Dielectric strength test set-up C.1.5 Test signal |
| 44 | C.2 Lead connector test C.2.1 Preconditioning C.2.2 Test method |
| 45 | C.2.3 Acceptance criteria |
| 46 | C.3 Connector cavity test C.3.1 Test pin C.3.2 Preconditioning C.3.3 Test method |
| 47 | C.3.4 Acceptance criteria |
| 48 | Annex D Rationale for Annex C D.1 Rationale for performing a high voltage electrical isolation test D.2 Rationale for test method D.2.1 Test signal |
| 49 | D.2.2 Mechanical load D.2.3 Test duration and combinations D.2.4 Test combinations D.3 Rationale for acceptance criteria D.3.1 Maximum allowed leakage current D.3.2 Measurement D.3.3 Frequency of monitoring |
| 50 | D.4 Informative test combinations for connector cavities and lead connectors D.4.1 General D.4.2 High voltage (DF4) connector cavities D.4.3 Low voltage only (IS4) connector cavities used in high voltage devices D.4.4 Low voltage only lead connectors D.4.5 Induced voltages on four-pole connectors |
| 52 | Annex E Current-carrying test high voltage types E.1 General E.2 Specimen preparation E.3 Test signal E.4 Equipment E.5 Lead connector testing E.5.1 General |
| 53 | E.5.2 Lead connector current-carrying capacity test method |
| 54 | E.5.3 Acceptance criteria |
| 56 | E.6 Connector cavity testing E.6.1 General E.6.2 Connector cavity current-carrying capacity test method E.6.3 Acceptance criteria |
| 57 | Annex F Rationale for Annex E F.1 Rationale for performing a current-carrying test F.2 Test parameters |
| 58 | F.3 Voltage drop across contact for the connector cavity F.4 Post-test requirements for the lead connector F.5 Connector cavity post-test withdrawal force |
| 59 | Annex G Lead connector fatigue strength test G.1 General G.2 Rationale for flex fatigue strength testing |
| 61 | Annex H Lead connector seal zone materials H.1 General H.2 Annealing H.3 Hardness H.4 Rationale for hardness H.5 Use of silicone rubber compounds |
| 62 | H.6 Rationale for recommendation against using silicone rubber compounds/composites |
| 63 | Annex I Seal zone creep I.1 General I.2 Summary of efforts to develop creep requirements I.2.1 General |
| 64 | I.2.2 Interchangeability testing I.2.3 Design limit testing |
| 66 | I.3 Limits on lead connector creep |
| 67 | I.4 Limits on connector cavity seal pressure I.5 Rationale for rejecting proposed requirements for lead connector creep performance and connector cavity seal pressure |
| 69 | Annex J Contact resistance stability J.1 General J.2 Limits for contact resistance J.3 Set-up J.3.1 Specimens J.3.2 Test pin J.3.3 Current-carrying test equipment |
| 70 | J.3.4 Contact resistance test equipment J.4 Procedure J.4.1 General |
| 71 | J.4.2 Preconditioning J.4.3 Static no-load contact resistance J.4.3.1 Objective J.4.3.2 Method J.4.3.3 Acceptance criterion J.4.4 Dynamic contact resistance stability J.4.4.1 Objective J.4.4.2 Method |
| 72 | J.4.4.3 Acceptance criteria |
| 73 | Annex K Rationale for Annex J K.1 General K.2 Limits for contact resistance K.3 Rationale for method K.3.1 Preconditioning K.3.2 Static no-load contact resistance |
| 74 | K.3.3 Short-term dynamic contact resistance stability K.3.3.1 General K.3.3.2 Minimum applied load K.3.3.3 Maximum applied voltage K.3.3.4 Maximum applied current K.3.3.5 Sampling resolution K.3.3.6 Equipment |
| 76 | Annex L Selection of contact materials L.1 General L.2 Potential system level considerations |
| 77 | L.3 Additional considerations |
| 78 | Annex M Lead connector contact material requirements M.1 General M.2 Contact resistance M.2.1 Requirement |
| 79 | M.2.2 Test samples and preconditioning M.2.3 Test method |
| 80 | M.3 Corrosion M.3.1 General M.3.2 Corrosion resistance to localized or crevice corrosion M.3.2.1 General |
| 81 | M.3.2.2 Acceptance criterion 1 M.3.2.3 Acceptance criterion 2 M.3.3 General corrosion M.4 Material hardness |
| 82 | Annex N Rationale for Annex M N.1 Materials N.2 Surface contact resistance |
| 85 | N.3 Preconditioning |
| 86 | N.4 Test method N.5 Fretting sensitivity numbering N.6 Corrosion N.6.1 General |
| 87 | N.6.2 Corrosion resistance to localized or crevice corrosion N.6.3 General corrosion |
| 89 | Annex O Rationale for requirements in this International Standard O.1 Need for a connector standard O.2 Selection of basic design concept and approach to standardization |
| 90 | O.3 Selection of basic design concept O.4 Rationale and explanation for requirement elements — Lead connector O.4.1 General O.4.2 Functional contact zones (connector cavity) O.4.3 Functional seal zones (connector cavity) |
| 91 | O.4.4 Pristine contact zones (lead connector) O.4.5 Pristine seal zones (lead connector) O.4.6 Areas between pristine contact zones and pristine seal zones (lead connector) |
| 92 | O.5 Rationale for requirement elements — Lead connector O.5.1 Lead connector pin dimensions O.5.2 Lead connector functional check O.5.3 Tensile loads O.5.4 Deformation due to pin contact forces O.5.5 Deformation due to ring contact forces |
| 93 | O.6 Rationale for requirement elements — Connector cavity O.6.1 Dimensions O.6.2 Insertion and withdrawal force |
| 94 | O.6.3 Retention force O.6.4 Contact load O.7 Connector types and combinations O.7.1 High voltage and low voltage only versions O.7.2 Permitted configurations |
| 95 | O.7.3 Integrated bipolar O.7.4 System compatibility |
| 96 | O.8 Inadvertent use with IS-1 and DF-1 |
| 97 | Annex P Connector products (e.g. adaptors, extenders, patient cables, etc.) P.1 General P.2 Special considerations for implantable adaptors and extenders P.3 Special considerations for non-implantable connector products |
| 99 | Bibliography |
