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YY/T 1933-2024: Particular specification for MR injector
YY/T 1933-2024
YY
MEDICAL INDUSTRY STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.50
CCS C 39
Particular specification for MR injector
ISSUED ON. JULY 08, 2024
IMPLEMENTED ON. JULY 20, 2025
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Terms and definitions... 4
4 Composition and classification... 7
5 Requirements... 7
6 Test methods... 10
Bibliography... 20
Particular specification for MR injector
1 Scope
This document specifies the requirements for magnetic resonance (MR) injector
(hereinafter referred to as injectors) and describes the corresponding test methods.
This document applies to injectors.
This document does not apply to single-use high-pressure contrast syringes and their
accessories dedicated to injectors.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB 9706.224, Medical electrical equipment -- Part 2-24.Particular requirements
for the basic safety and essential performance of infusion pumps and controllers
YY/T 0482, Medical Magnetic Resonance Imaging Equipment -- Determination of
Main Image Quality Parameters
YY/T 0935, Particular specifications for CT injector
3 Terms and definitions
For the purposes of this document, the terms and definitions defined in GB 9706.224,
YY/T 0935, YY/T 0482 as well as the followings apply.
3.1 MR injector
A device that in the diagnosis of magnetic resonance imaging, in order to obtain the
required medical images, the contrast agent is injected into the human body according
to the set flow rate and injection dose in conjunction with the magnetic resonance
equipment.
3.2 injector head
An interface component for injection push mechanism and installation of matching
syringe.
3.10 keep-vein-open rate; KVO
Under specified conditions, the injector returns to a predetermined low speed state
while keeping the patient line open.
NOTE. The abbreviation KOR (keep open rate) is often used as a synonym for KVO.
[Source. GB 9706.224-2021, 201.3.209, modified]
3.11 signal to noise ration; SNR
The quotient of the signal value divided by the noise value.
[Source. YY/T 0482-2022, 3.1.26]
3.12 signal-to-noise ratio change
Changes in the signal-to-noise ratio of the reference image when the instrument is
working and when the instrument is not working.
3.13 magnetically induced displacement force
The force exerted on a magnetic object exposed to the spatial gradient of a static
magnetic field.
NOTE. This force is expected to cause objects to move in the spatial gradient of the static magnetic
field.
[Source. ASTM F2503-20, 3.1.4]
3.14 magnetically induced displacement
A magnetic object in a spatial gradient magnetic field moves toward a magnetic
resonance device due to the magnetically induced displacement force.
3.15 artifact
What is visible in the image neither reflects the structure of the corresponding position
in the object nor can it be explained by noise.
[Source. YY/T 0482-2022, 3.1.2]
3.16 immunity (to a disturbance)
The ability of me equipment or me system to operate without degradation in the
presence of electromagnetic disturbances.
[Source. YY 9706.102-2021, 3.13]
3.17 region of interest
safety distance, the injector shall not produce magnetically induced displacement.
If the injector has casters, verify that the casters are unlocked.
NOTE. The magnetic induction value is generally regarded as the field strength value of the
magnetic field, with the unit of T. Bo is the static magnetic field generated by the magnetic resonance
device and its accessories. Scalars are generally represented by ordinary fonts (such as B). Bold
fonts represent vectors (such as B).
5.8.2 Immunity
The injector shall be able to operate normally at the applicable magnetic field strength
and the safety distance claimed by the manufacturer. The basic performance of the flow
rate shall not be reduced.
The flow rate shall meet the requirements of 5.1.
5.8.3 Signal-to-noise ratio change amount
At the applicable magnetic field strength and the claimed safety distance claimed by
the manufacturer, the variation in the signal-to-noise ratio of the reference image when
the injector is injecting and when there is no injector shall be less than ±10%.
5.8.4 Image artifact variation
At the applicable magnetic field strength and the safety distance claimed by the
manufacturer, the change in the ratio of the artifact signal value to the signal average
value in the magnetic resonance imaging reference image when the injector is injecting
and when there is no injector shall meet the requirements specified by the manufacturer.
NOTE. The change limit is determined by the manufacturer based on the applicable magnetic field
strength and the adapted magnetic resonance equipment.
5.9 Injector head rotation angle
If applicable, when the injector head is pointing upwards, ensure that all air in the
syringe is exhausted. When it is pointing downwards, the angle between it and the
horizontal plane shall be no less than 10°.
5.10 KVO features
The manufacturer shall specify the KVO interval, KVO dose per injection and deviation,
if applicable.
5.11 Functions
The injector shall have the following functions.
a) Injection time display, injection dosage display, flow rate setting or display;
b) When the injection pressure exceeds the pressure limit, a prompt shall be given
and the injection shall be stopped;
c) It shall have the function of controlling injection and stop outside the scanning
room;
d) The injection shall be able to be stopped at any time during the injection process.
5.12 Appearance
It shall meet the following requirements.
a) The surface shall be clean, uniform in color, free of sharp edges, burrs, scratches,
cracks and other defects;
b) The control device shall be firmly fixed and the control shall be reliable.
5.13 Marks and accompanying documents
5.13.1 Injector marks
The injector mark shall meet the following requirements.
a) Each part of the injector is provided with magnetic resonance environment safety
mark;
NOTE. Magnetic resonance environment safety marks shall comply with ASTM F2503-20
requirements.
b) The additional mark of magnetic resonance condition-safe products shall at least
indicate the applicable magnetic field strength and safety distance.
5.13.2 Accompanying documents
Injectors shall be accompanied by documentation including at least instructions for use
and technical specifications.
The accompanying documents shall contain at least the following information.
a) The strength of the magnetic field suitable for the injector;
b) The safety distance of injector;
c) The list of MRI devices compatible with the injector.
6 Test methods
6.1 Flow rate
The test medium is distilled water or deionized water. The injection dose is set to the
maximum value. The flow rate is set to the minimum value, 50% of the maximum value,
and the maximum value. Use a timer (such as a synchronized stopwatch) to record the
time from the start of injection to the end of injection. Use a balance to weigh the
distilled water or deionized water. Convert it to volume. Calcu...