YY/T 0987.2-2016 in English
VALIDMagnetic resonance compatibility for surgical implant - Part 2: Test method for magnetostrictive displacement
- Issued on:2016-03-23
- Implemented on:2017-01-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$127.00
本标准适用于可用线悬挂的器械(比如支架)。
本标准规定了医疗器械由于静态梯度磁场所产生的磁致位移力的试验方法及磁致位移力与器械重量的比较。
Scope
This part of YY/T 0987 includes test methods for the magnetic displacement force generated by medical devices due to static gradient magnetic fields and the comparison of the magnetic displacement force and the weight of the device. This section does not address other possible safety issues, including but not limited to magnetic torque, radiofrequency heating and heating, noise, interaction between devices, and functionality of the device and magnetic resonance system. This section applies to instruments that can be suspended by wires. Instruments that cannot be suspended by wires are not suitable. During the test, the weight of the thread used to suspend the instrument should be less than 1% of the weight of the test instrument. The tests in this section shall be carried out on a system in which the direction of the magnetically induced displacement force is horizontal. This section uses the values in the International System of Units as the standard, and the values in parentheses are for reference only. This section does not attempt to address all safety issues covered, even those related to its use. It is the responsibility of the users of this standard to establish appropriate safety and health practices and to clarify the applicability of regulatory limitations prior to application.

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