YY/T 0972-2016Active implantable medical devices-Four-pole connector system for implantable cardiac rhythm management devices-Dimensional and test requirements (English PDF)

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

This standard uses the re-drafting method to modify the use of ISO 27186.:2010 (first edition) "active implantation of medical devices implantable cardiac rhythm Device quadrupole connector system size and test requirements ".

The main differences between this standard and ISO 27186.:2010 (first edition) are as follows.

--- For the standard cited in the standard, if China has been converted into domestic standards, then refer to our standards;

--- According to the Chinese version of the requirements, page number, font and font size, etc. have been modified, does not affect the degree of consistency;

1 Scope

This standard applies to quadrupole connector systems for implantable pacemaker devices with pacing, ECG perception and/or defibrillation. This standard Specifies the requirements for the part of the implantable electrode lead connector and the requirements for the inner cavity of the connector attached to the enclosed implanted pulse generator.

Set the basic dimensions and performance requirements and their adaptation test methods.

This standard is not intended to replace existing unipolar or bipolar connector standards (eg ISO 11318 and YY/T 0491). This standard does not Suitable for systems that can output high voltages above 1000V and/or 50A. This standard does not apply to those who do not support traditional pacing, ECG Knowledge and/or defibrillation function of the sensor or special electrode system.

This standard does not specify all connector characteristics. The standard is not clear functional compatibility, electrode wire safety and reliability and pulse generator with System adaptation requirements.

WARNING - If the implantable pulse generator is able to conduct a dangerous non-pacing stimulus signal through the contact portion of the lumen (eg, Defibrillation), it is not possible to use the connector cavity for low voltage only specified in this standard. Likewise, this standard provides for High voltage electrode connectors can not be used in electrode lines for low voltage therapy.

Note. Electrode conductors and pulse generator connectors that do not meet this standard may be safe, reliable, and may have clinical advantages.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 74. 1985 Slotted terminal set screws (ISO 7436. 1983, MOD)

ASTMA276 stainless steel bar and profile standard (StandardSpecification forStainlessSteelBarsand Shapes Standard Specification for Titanium and Titanium Alloy Rods and Billets (StandardSpecification for Titaniumand TitaniumAloyUGISanobilets)

ASTM F562 Standard Specification for Forged Cobalt-Chromium-Molybdenum Alloy for Surgical Implantation (StandardSpecification forWught)

35Cobalt-35Nickel-20Chromium-10MolybdenumAloyforSurgicalImplantApplications ASTM F746-04 Standard Test Method for Dent or Fissure Corrosion of Metallic Surgical Implants (StandardTestMethod forPittingorCreviceCorrosionofMetalicSurgicalImplantMaterials)

Standard Test Method for Evaluation of Connection Properties of Electrical Conductor Materials by ASTMB896 (StandardTestMethods forEvaluating ConnectabilityCharacteristicsofElectricalConductorMaterials)

3 Terms and definitions

The following terms and definitions apply to this document.