Skip to product information
1 of 12

PayPal, credit cards. Download editable-PDF & invoice in 1 second!

YY/T 0987.1-2016 English PDF (YYT0987.1-2016)

YY/T 0987.1-2016 English PDF (YYT0987.1-2016)

Regular price $135.00 USD
Regular price Sale price $135.00 USD
Sale Sold out
Shipping calculated at checkout.
Quotation: In 1-minute, 24-hr self-service. Click here YY/T 0987.1-2016 to get it for Purchase Approval, Bank TT...

YY/T 0987.1-2016: Implants for surgery. Magnetic resonance compatibility. Part 1: Safety marking

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.
YY/T 0987.1-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.40
C 35
Implants for Surgery - Magnetic Resonance
Compatibility - Part 1. Safety Marking
??????????????? ????????????????€?
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.

View full details