YY/T 0987.2-2016: Implants for Surgery - Magnetic Resonance Compatibility - Part 2: Magnetically Induced Displacement Force Test Method

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Scope

This Part of YY/T 0987 includes test method for magnetically induced displacement
force generated by medical devices as a result of static gradient magnetic field; a
comparison of magnetically induced displacement force and the weight of medical
devices.
This Part does not involve other possible safety questions. These safety questions
include, but are not limited to, magnetically induced torque, radio frequency heating
and radio frequency induced heating, noise, interaction among medical devices,
functions of medical devices and magnetic resonance system.
This Part is applicable to devices that can be hanged through wires. This Part is not
applicable to devices that cannot be hanged through wires. During the test, the weight
of wires used to hang devices shall be less than 1% of the weight of devices being
tested.
The test in this Part shall be conducted in a system, in which, the direction of
magnetically induced displacement force is horizontal.
This Part adopts numerical value under international system of units as the standard;
numerical value in the brackets shall merely be considered as reference.
This Part does not attempt to elaborate all the involved safety questions, even though
those safety questions are related with the usage. Determining appropriate safety and
health specifications and clarifying the applicability of management limit before
application is the responsibility on the users of this Standard.

Basic Data

Standard ID	YY/T 0987.2-2016 (YY/T0987.2-2016)
Description (Translated English)	Implants for Surgery - Magnetic Resonance Compatibility - Part 2: Magnetically Induced Displacement Force Test Method
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C35
Classification of International Standard	11.040.40
Word Count Estimation	11,151
Date of Issue	2016-03-23
Date of Implementation	2017-01-01
Regulation (derived from)	Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies)	State Food and Drug Administration