ISO 27186:2010
Space systems - Programme management - Quality assurance requirements

Standard No.
ISO 27186:2010
Release Date
2010
Published By
International Organization for Standardization (ISO)
Status
Replace By
ISO 27186:2020
Latest
ISO 27186:2020
Scope
This International Standard specifies a four-pole connector system for implantable cardiac rhythm management devices which have pacing, electrogram sensing and/or defibrillation functions. This International Standard includes requirements for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods.

ISO 27186:2010 Referenced Document

  • ASTM A276 Standard Specification for Stainless Steel Bars and Shapes
  • ASTM B348 Standard Specification for Titanium and Titanium Alloy Bars and Billets*2024-04-19 Update
  • ASTM B896 Standard Test Methods for Evaluating Connectability Characteristics of Electrical Conductor Materials
  • ASTM F562 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)*2022-01-01 Update
  • ASTM F746-04 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials*2024-04-19 Update
  • ISO 7436 Slotted set screws with cup point

ISO 27186:2010 history

  • 2020 ISO 27186:2020 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
  • 2010 ISO 27186:2010 Space systems - Programme management - Quality assurance requirements



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