YY/T 0987.1-2016 PDF in English
YY/T 0987.1-2016 (YY/T0987.1-2016, YYT 0987.1-2016, YYT0987.1-2016)
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Implants for surgery. Magnetic resonance compatibility. Part 1: Safety marking
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Standards related to (historical): YY/T 0987.1-2016
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YY/T 0987.1-2016: PDF in English (YYT 0987.1-2016) YY/T 0987.1-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
Implants for Surgery - Magnetic Resonance
Compatibility - Part 1. Safety Marking
外科植入物 磁共振兼容性
ISSUED ON. MARCH 23, 2016
IMPLEMENTED ON. JANUARY 1, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 6
4 Significance and Application ... 8
5 Marking Method ... 9
6 Necessary Information ... 9
7 Information Contained in MR Marking ... 9
Appendix A (Informative) Principle ... 18
Implants for Surgery - Magnetic Resonance
Compatibility - Part 1. Safety Marking
1 Scope
This Part of YY/T 0987 specifies safety marking of medical devices and other items in
the magnetic resonance (MR) environment, so as to provide prompt message on safety.
NOTE 1. other than implants for surgery, other medical devices or items that enter the
magnetic resonance environment can also refer to this Part for safety marking.
NOTE 2. If this Part conflicts with relevant laws and regulations, the laws and regulations
shall prevail.
This Part has the following purposes.
(1) Suggest that an item, that might enter MR environment, should be permanently
marked, so as to indicate whether this item is safe in MR environment;
(2) Suggest the information that shall be included in the marking.
Sometimes it is not realistic to directly mark on implants and certain medical devices.
When it is impossible to directly mark on them, it is suggested to mark on labels and
patients’ information cards.
This Part does not include the content of image artifact, because artifact does not
belong to the issue of safety.
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.
2 Normative References
The following documents are indispensable to the application of this Standard. In terms
of references with a specified date, only versions with a specified date are applicable
to this Standard. The latest version (including all the modifications) of references
without a specified date is also applicable to this Standard.
GB/T 2893.1-2004 Graphical Symbols - Safety Colors and Safety Signs - Part 1.
boldface (for example, B).
3.6 Magnetic Resonance; MR
Magnetic resonance refers to atomic particle swarm’s resonance absorption of
electromagnetic field energy in the magnetic field.
3.7 Magnetic Resonance (MR) Environment
Magnetic resonance environment refers to the space within 0.5 mT (5G) line in MR
system, including the whole three-dimensional space around MR scanner. When 0.5
mT line is included in Faraday cage, the whole space shall be deemed as magnetic
resonance (MR) environment.
3.8 Magnetic Resonance System
MR System
Magnetic resonance system refers to the combination of magnetic resonance
equipment, accessories (including display, control and energy supply devices) and
controlled entry zone (if provided).
3.9 MR Conditional
MR conditional refers to items that do not generate already known hazards under
specific MR environment and specific working conditions. In magnetic field, the specific
MR environment includes magnetic field strength, magnetic field spatial gradient,
magnetic field time variation rate (dB/dt), radio frequency (RF) field and specific
absorption rate (SAR). Other than these, it also might include items’ special
configuration.
3.10 MR Safe
MR safe refers to items that do not generate already known hazards in all MR
environments.
NOTE. MR safe items include non-conductive and non-magnetic items, for example,
plastic petri dish. Whether items are MR safe can be determined in accordance
with scientific theories, not experimental data.
3.11 MR Unsafe
MR unsafe refers to items that generate hazards in all MR environments.
NOTE. MR unsafe items include magnetic items, for example, ferromagnetic scissors.
3.12 Medical Device
Manufacturer’s expected purposes for medical devices used on human beings, either
5 Marking Method
Marking shall not influence the performance or functions of items being marked. In
addition, within the expected service life, marking shall maintain its readability.
6 Necessary Information
Through experiments, obtain items’ behavior attributes in MR environment, especially
items’ magnetically induced displacement force (refer to YY/T 0987.2), magnetically
induced torque (refer to YY/T 0987.5) and radio frequency induced heating (refer to
YY/T 0987.4) in MR environment.
NOTE. other possible safety questions, include, but are not limited to, thermal damage,
induced current/voltage, electromagnetic compatibility, nerve stimulation, noise
and interaction among devices, functional safety of devices and safe operation of
MR system.
Any parameters that might influence items’ safety performance shall be listed out;
conditions that generate hazards shall be described.
7 Information Contained in MR Marking
Since medical devices and other items have various dimensions, the content contained
in practical marking also differs. In terms of implants, MR marking shall be added on
package’s label (including instruction on usage and package inserts) and patients’
information cards. In terms of non-implants applied in MR environment, marking shall
be added on a conspicuous location and label. Certain items (for example, extremely
small or extremely thin items) don’t have sufficient surface for marking; when it is
impossible for direct marking, marking shall be added on the label.
Information that shall at least be provided---in accordance with the test mentioned in
Chapter 6, use the markings in Table 1 and Table 2 to mark items as MR safe, MR
conditional and MR unsafe.
The marking of MR safe is constituted of a green block with the letter “MR” (refer to
Table 1). There are two optional modes. when colorful marking is not applicable, use
black and white printing (refer to Table 2). In order to enhance the degree of
recognizability and the amount of information, it is strongly suggested that colorful
marking shall be adopted. In terms of the colorful marking and black and white marking
in Table 1 and Table 2, choose the marking that would the most easily be recognized
by individuals.
The marking of MR conditional is constituted of a yellow equilateral triangle with the
letter “MR”, and black peripheral frame (refer to Table 1). The bottom line of the triangle
Appendix A
(Informative)
Principle
A.1 This Part aims at using a group of easily recognizable markings and terms to
indicate items’ safety in or near MR scanner. In 1997, in the guidance draft of
Interactive Influence of Medical Devices and Magnetic Resonance Imaging System,
FDA defined two terms for the first time. MR safe and MR compatible, so as to describe
the safety in MR system and peripheral devices. The definitions previously used are
as follows.
MR safe. after being proved by experiments, devices that do not generate hazards to
patients or other individuals in MR environment but might have influence on the
diagnostic information. When MR safe or MR compatible is being marked, test
conditions shall be clarified, because a device’s safety or compatibility in a certain
environment does not signify that it is also safe in magnetic resonance environment,
which is extremer.
MR compatible. devices that are safe in magnetic resonance environment; have no
obvious influence on diagnostic information and can be normally operated. When MR
safe or MR compatible is being marked, test conditions shall be clarified, because a
device’s safety or compatibility in a certain environment does not signify that it is also
safe in magnetic resonance environment, which is extremer.
However, this kind of definition would easily lead to utmost confusions and often lead
to misunderstandings. Users often wrongly assume that items with the marking of MR
safe or MR compatible are safe or compatible in any MR environment. The differences
of MR environment mainly reflect in magnetic field strength and radio frequency
conditions. Therefore, the influence on items under a certain condition might differ from
the influence on items under another condition. In addition, some devices which are
marked MR safe or MR compatible in accordance with the old terms are requested to
be attached with the restriction of Gaussian line or the restriction of radio frequency
pulse sequence, so as to guarantee the devices’ safe application in MR environment.
In brief, if test conditions are not clearly pointed out, it is impossible to determine
whether a device is MR safe or MR compatible.
A.2 This Part proposes new terms (MR safe, MR unsafe and MR conditional), which
aims at eliminating these confusions. This Part amends the definition of the term MR
safe. In the new definition in 3.10, MR safe refers to items that do not generate hazards
in any MR environment, which signifies that the items would not generate any hazards
when they are brought to MR environment or are applied to any MR environment. MR
unsafe refers to items that would generate hazards in any MR environment, hence,
they are not allowed to be applied to any MR environment. MR conditional refers to
or in vivo of patients’ body are ferromagnetic materials or non-ferromagnetic materials
before they enter MR environment. These devices and items include fire extinguisher,
oxygen cylinder, intravascular wire, wrench and other instruments, etc. The following
criteria are general rules of determining which items shall be marked before entering
MR environment.
a) All electric (AC or DC) instruments in MR environment. Generally speaking, this
type of items contains magnetic materials; shall receive corresponding
evaluation and marking;
b) Items that are already known to contain metal material components or metal
subcomponents, or devices that are already known to contain magnetic
materials or conductive materials. Please be noted that some items contain
metal material components, but in an extremely inconspicuous way (for
example, certain items on sandbag, pillow, battery and clothes, etc.).
Meanwhile, some non-metal materials (for example, composite carbon fiber)
are also conductors, which would generate radio frequency induced heating
hazard;
c) All items that are about to be placed in MR imaging cavity.
Some items would not bring hazards in MR environment, such as most glass and
plastic products, and wooden products (non-metal nails or metal screws). Thus, they
do not need to receive MR safe marking in usage. However, in terms of undetermined
items, they shall be rigorously distinguished before entering MR environment. These
non-compatible materials shall be screened as meticulously as treating patients.
Generally speaking, if devices or items that are marked in accordance with the
stipulation in this Part can avoid potential hazards and even delays in scanning, then
it shall be deemed that the marking is appropriate.
A.4 Image artifact
Since image artifact is not an issue of safety, it does not belong to the category in this
Part. In order to provide clinicians with additional information to help them determine
whether it is appropriate for patients with implants or other items (for example, external
fixing brackets or splints) to enter MR scanning cavity for scanning, the artifact
condition of the items shall be described on the label. In terms of devices that need
patients’ information cards, artifact information shall be indicated on patients’
information cards. YY/T 0987.3 provides the evaluation method for image artifact of
passive implants. In terms of other devices and items, other methods might be needed
to acquire information regarding image artifact.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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