YY/T 0987.4-2016Magnetic resonance compatibility for surgical implant - Part 4: Test method for radio-frequency heat (English PDF)

Foreword

YY/T 0987 "Surgical Implants Magnetic Resonance Compatibility" is divided into the following sections.

- Part 1. Safety markings;

- Part 2. Magnetic flux force test method; Part 3. Image artifact evaluation method;

- Part 4. Radiofrequency test method;

- Part 5. Magneto - induced torque test method. This part is part 4 of YY/T 0987.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

This section uses the re-drafting method for reference to ASTM F2182-2011a "Magnetic Resonance Environment in Passive Implants and Surrounding Tissues Radio Frequency Heat test method "preparation.

The technical differences between this section and ASTM CF2182-2011a are as follows.

--- on the normative reference documents, this part has made a technical differences in the adjustment to meet China's technical conditions, adjust the situation The situation is reflected in Chapter 2, "Normative references", as follows.

- Replacement with ASTM Y2503-08 with YY/T 0987.1;

YY/T 0987.2 instead of ASTM F2052-06;

YY/T 0987.3 instead of ASTM F2119-07;

- Replacement with ASTM Y2213-06 with YY/T 0987.5; Replace Y 601-2-33..2002 with YY 0319-2008;

--- remove the content of polyacrylic acid partial sodium salt and hydroxyethyl cellulose brand;

- Remove Chapter 11, Chapter 12 and Appendix X1.10 of ASTM F2182-11a.

1 Scope

This part of YY/T 0987 specifies tests for radiofrequency (RF) heating on passive implants or surrounding tissue by magnetic resonance imaging (MRI) method.

This part of the test method is to determine whether the presence of medical devices in the MR imaging process will lead to injury to the patient one of the test methods.

Other safety issues that need to be addressed include magnetic flux and torque and the functional realization of various configurations of medical devices in the MR environment.

At a given specific absorptivity (SAR), the temperature rise caused by radio frequency depends on the frequency of the radio frequency, which in turn depends on the Magnetic field strength. The test methods in this section focus on the 1.5T or 3T cylindrical MR system, the MR system for other static magnetic field strengths Or magnet design, this part of the test method can be modified to evaluate the RF caused by the temperature rise.

This part of the test hypothesis is carried out when the implant is completely in the body. For other implant conditions (such as external fixation equipment, puncture needle, guide Tube or tethered equipment such as ablation probe), the need to modify the test method.

This part of the test method is applicable to a whole body magnetic resonance device with a whole body radio frequency transmitting coil, which is defined in YY 0319-2008 2.2.103, the definition of the whole body radio frequency transmitter coil see 2.2.100. Assume that the RF coil is an orthogonal excitation coil.

This part uses the international unit value as the standard, this part does not contain other units of measurement.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

Medical electrical equipment - Part 2-33. Particular requirements for the safety of magnetic resonance devices for medical diagnostics (IEC 60601-2 - 33..2002, IDT)

YY/T 0987.1 Surgical implants - Magnetic resonance compatibility - Part 1. Safety signs

YY/T 0987.2 Magnetic resonance compatibility of surgical implants - Part 2. Magnetic susceptibility test method

YY/T 0987.3 Magnetic resonance compatibility of surgical implants - Part 3. Image artifact evaluation method

YY/T 0987.5 Surgical implants - Magnetic resonance compatibility - Part 5. Magnetic torques test method NEMAMS8-2008 magnetic resonance imaging system specific absorption rate characteristics (Characterizationofthespecificabsorp-tionrate

3 Terms and definitions

The following terms and definitions apply to this document.