神经刺激器铅测试

Neurostimulation is a fast-growing field with many recent technological advancements.FDA-approved neurostimulation systems include spinal cord, 脑深部, 骶神经,迷走神经刺激, while emerging technologies such as hypoglossal, 胃,and carotid artery stimulation systems are under development.

The neurostimulation devices market was estimated at $3.2015年为60亿美元，预计将达到50亿美元.到2020年达到80亿美元^1,2.

The recently-updated standard ISO 14708-3:2017 Implants for surgery – Active implantable medical devices – Part 3:Implantable neurostimulators specifies the requirements for active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system to provide basic assurance of safety for patients and users.

im体育APP has extensive experience testing neurostimulation devices per ISO 14708-3, ISO 14708 - 1, IEC 60601-1和IEC 62353^3,4. Below, we have outlined examples of tests that we routinely perform.

身体弯曲测试

The goal of this test is to demonstrate structural integrity by simulating the in vivo mechanical conditions that the device will be subject to. The body flex test is a pass/fail test performed at the center of the electrode using a custom-designed fixture for a predetermined number of cycles, flexing degrees and test frequency mimicking normal conditions of use using a TA ElectroForce 3300 axial/torsion test system.

样品在测试前和测试后进行检查 under an optical microscope for any axial or longitudinal cracks or other anomalies. Electrical functionality testing is also performed pre- and post-testing.

插管试验

The objective of the cannula insertion test is to meet the customer-defined device durability requirements. A custom-designed fixture is positioned at a pre-specified angle, and the cannula is inserted and withdrawn for a predetermined number of times in ambient air conditions.

The insertion flex angle of the cannula insertion fixture used is verified withimage analysis software. Pre- and post-testing optical microscope inspections and current amplitude values for each electrode are also performed.

耐久性试验

耐久性试验, samples are typically subject to a static tensile load in ambient air conditions without preconditioning using a TA ElectroForce 3300 axial/torsion test system. Test parameters are selected such that they emulate device use.

Custom-designed fixturing is used to grip the samples and the following measurements and inspections are performed pre- and post-testing: sample length, 电功能, and optical microscopy to identify any sample anomalies or defects.

扭力测试

The neurostimulator torsion test uses custom-designed adapters (shown on the right) on a TA ElectroForce 3300 axial/torsion test system. Samples are torqued to customer-provided test parameters that emulate device use. Stimulator lead inspections under an optical microscope and 电功能 tests are performed pre- and post-torsional testing.

漏电试验

Current leakage testing is performed per IEC 60601-1 using an LCR (inductance (L), 电容(C)和电阻(R)表. Optical microscopy inspection is performed pre- and post-current leakage testing.

样式插入和取出测试

The lead stylet is inserted into and withdrawn from the stimulator body while attached to a force gauge so that peak insertion and withdrawal forces can be measured. Number of cycles and acceptable peak forces are determined by the device manufacturer. 在测试前和测试后对样品进行检查.

去颤暴露

Neurostimulators are subject to defibrillation exposure testing in a custom-designed defibrillation exposure box designed to prescribed capacitance, inductance and impedances of the inductor and the defibrillation pulse generator specifications. 时间顺序在ISO 14708 - 1中有描述. 在测试前和测试后对样品进行检查 for any anomalies or defects.

介电强度试验

This test measures the dielectric strength of the insulation between the electrode circuits of the stimulator after sample preconditioning (consult IEC 60601-1和IEC 62353). A custom-designed high potential fixture is used for this test with a Hipot dielectric analyzer. 样品在测试前和测试后进行检查.

压力暴露试验

Neurostimulators are expected to withstand changes in pressure that can occur during transit or normal conditions of use. ISO 14708 - 1 specifies that the effects of deformation due to absolute pressures at 70 kP ± 3,5kp和150kp±7,5 kP applied for not less than 1 h should be investigated to check compliance.

极限拉伸试验

The receiver’s ultimate tensile strength is measured using our Instron 5944 tensile tester.Preconditioned samples were inspected prior to testing, attached to the tester with clamp-style grips and pulled to failure in load control at a pre-determined rate and inspected post testing.

参考文献

1 http://www.grandviewresearch.com/industry-analysis/neurostimulation-devices-industry

2 http://www.strategyr.com/MarketResearch/Neurostimulation_Market_Trends.asp

3 http://www.iso.org

4 http://www.iec.ch/