YY/T 1469-2016 PDF in English
YY/T 1469-2016 (YY/T1469-2016, YYT 1469-2016, YYT1469-2016)
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Electrical infusion pump for ambulatory use
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Standards related to (historical): YY/T 1469-2016
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YY/T 1469-2016: PDF in English (YYT 1469-2016) YY/T 1469-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Electrical infusion pump for ambulatory use
ISSUED ON: JANUARY 26, 2016
IMPLEMENTED ON: JANUARY 01, 2017
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Technical requirements ... 6
5 Test method ... 11
Appendix A (Informative) Guidelines and compilation instructions ... 20
Electrical infusion pump for ambulatory use
1 Scope
This Standard specifies the definition, basic requirements and corresponding
test methods of electrical infusion pump for ambulatory use (hereinafter referred
to as infusion pump for ambulatory use).
This Standard applies to electrical infusion pump for ambulatory use which are
used in medical monitoring environments; the intended use of this product is for
intravenous or epidural analgesic administration.
The infusion pump for ambulatory use is mainly composed of a drive unit, a
restoration set and an infusion line; the restoration set and the infusion line are
single-use components.
This Standard does not apply to the following equipment:
-- equipment which is specially used for diagnostics or similar purposes (such
as high-pressure injectors);
-- gastrointestinal feeding pump;
-- equipment for extracorporeal blood circulation;
-- insulin pump and pumps for similar clinical applications;
-- infusion pump for ambulatory use that has special requirements for
infusion accuracy.
2 Normative references
The following documents are indispensable for the application of this document.
For dated references, only the dated version applies to this document. For
undated references, the latest edition (including all amendments) applies to this
document.
GB/T 1962.1-2015, Conical fittings with a 6% (Luer) taper for syringes,
needles and certain other medical equipment - Part 1: General requirement
GB/T 1962.2-2001, Conical fittings with a 6% (Luer) taper for syringes,
needles and certain other medical equipment - Part 2: Lock fittings
GB 9706.1-2007, Medical electrical equipment - Part 1: General
requirements for safety
GB 9706.27-2005, Medical electrical equipment - Part 2-24: Particular
requirements for the safety of infusion pumps and controllers
GB/T 14233.1-2008, Test methods for infusion, transfusion, injection
equipment for medical use - Part 1: Chemical analysis methods
GB/T 14233.2-2005, Test methods for infusion, transfusion, injection
equipment for medical use - Part 2: Biological test methods
GB/T 14710-2009, Environmental requirement and test methods for medical
electrical equipment
GB/T 16886, Biological evaluation of medical devices
YY 0286.1-2007, Special infusion sets - Part 1: Infusion sets with precision
filters for single use
YY 0451-2010, Portable infusion devices for single use - Non electrically
driven
YY 0505-2012, Medical electrical equipment - Part 1-2: General
requirements for safety - Collateral standard: Electromagnetic compatibility -
Requirements and tests
YY 0709-2009, Medical electrical equipment - Part 1-8: General
requirements for safety - Collateral standard: General requirements, tests
and guidance for alarm systems in medical electrical equipment and medical
electrical systems
YY 0770.1-2009, Fitter material for medical infusion equipment - Part 1: Fluid
filter material
3 Terms and definitions
Terms and definitions determined by GB 9706.27-2005 and the following ones
are applicable to this document. For ease of use, some of the terms and
definitions in GB 9706.27-2005 are repeated below.
3.1 Infusion pump
The device that is expected to control the flow of fluid into the patient's body by
the positive pressure that is generated by the pump.
[GB 9706.27-2005, definition 2.101]
The appearance of the infusion pump for ambulatory use shall be uniform in
color, clean on the surface, free from scratches and cracks; the text and marks
shall be clear and durable.
4.1.2 Installation requirements
The combination of the various parts of the infusion pump for ambulatory use
shall be firm, and no automatic flow phenomenon shall occur after the
combination.
4.1.3 Infusion accuracy
4.1.3.1 The accuracy of the average infusion speed in continuous infusion
mode shall be better than ±10%.
4.1.3.2 The accuracy of infusion speed and infusion volume of the infusion
pump for ambulatory use which has patient-controlled analgesia (PCA)/bolus
infusion mode shall be better than ±10%; if there is a lock time interval, the
accuracy shall be better than ±10 s.
4.1.3.3 The accuracy of time-sharing infusion of the infusion pump for
ambulatory use which has chronological infusion mode shall be better than
±10%.
4.1.4 Blocking pressure, triggering time and the produced bolus volume
4.1.4.1 The infusion blocking pressure alarm threshold value shall be specified
in the random file; the accuracy shall be better than ±20%.
4.1.4.2 The time that is required for the blocking alarm to trigger shall not be
greater than the manufacturer's claimed value.
4.1.4.3 The bolus volume, that is produced when the infusion pump for
ambulatory use is running at medium speed and reaching the blocking alarm
threshold, shall not be greater than the manufacturer's claimed value.
4.1.5 Continuous working time
When the infusion pump for ambulatory use operates at medium speed, it shall
be able to continue to work normally for at least 25 h or until the solution in the
restoration set is exhausted, whichever is shorter.
4.2 Alarm information requirements
4.2.1 The infusion pump for ambulatory use shall contain at least the following
alarm information, and shall use visual alarm and auditory (or other effective
methods such as vibration) alarm:
The infusion line of the system shall be equipped with a filter whose pore size
is less than or equal to a 5 μm filter membrane; the filtration rate of the filter to
the latex particles shall not be less than 90%.
4.3.1.4 Line
If the restoration set and the administration set of the infusion pump for
ambulatory use are split, the used connection system shall use a lock fitting.
The connection between the restoration set and the administration set shall be
able to withstand a 15 N static pulling force for 15 s.
4.3.1.5 Restoration set
The restoration set of the infusion pump for ambulatory use shall be designed
to be able to visually inspect the foreign matter and air bubbles in the contained
solution.
4.3.1.6 Particulate pollution
When the test is performed in accordance with Appendix A of YY 0451-2010 or
equivalent method, the pollution index shall not be greater than 90.
4.3.1.7 Filling capacity of restoration set
It shall not be less than the nominal capacity of the restoration set.
4.3.1.8 Residual amount of liquid medicine
The residual amount of liquid medicine in the infusion pump shall not exceed
the manufacturer's claimed value.
4.3.2 Chemical properties
4.3.2.1 Reducing substances
The volume difference of potassium permanganate solution [c(KMnO4) = 0.002
mol/L] that is consumed between the test solution and the blank solution shall
not exceed 2.0 mL.
4.3.2.2 Metal ions
When it is measured by atomic absorption spectrophotometry (AAS) or
equivalent method, the total content of barium, chromium, copper, lead, tin in
the leaching solution shall not exceed 1 μg/mL, and the content of cadmium
shall not exceed 0.1 μg/ mL.
The color of the test solution shall not exceed the standard control solution
whose mass concentration is ρ(Pb2+) = 1 μg/mL.
After connecting the infusion line, set the flow rate of the infusion pump to
medium speed (specified by the manufacturer); start the infusion pump until the
infusion is stopped due to the exhaustion of the battery; the continuous working
time of the infusion pump shall meet the requirements of 4.1.4.
5.3 Alarm information requirement test
5.3.1 Alarm information test method
5.3.1.1 Battery power alarm
After connecting the infusion line, use the battery that is recommended by the
manufacturer to power the infusion pump; set the flow rate to medium speed
(specified by the manufacturer); start the infusion pump until the battery power
alarm; the result shall meet the requirements of 4.2.1a) .
5.3.1.2 Mechanical failure alarm
Artificially jam the transmission mechanism of the infusion pump and start the
infusion pump; there shall be an alarm, and the result shall meet the
requirements of 4.2.1b).
5.3.1.3 Infusion blocking alarm
Connect the pressure sensor to the line and build the platform according to
Figure 2. Start the infusion pump and run at medium speed for not less than 5
min; block the outlet of the infusion pump; the infusion pump shall have an alarm;
the result shall meet the requirements of 4.2.1c).
5.3.1.4 Air input alarm
Check whether the device that prevents air from entering meets the
requirements. If an air detection and alarm system is used, after the infusion
pump runs, when the air detector detects a certain amount of air, it shall alarm
and stop the infusion immediately; the result shall meet the requirements of
4.2.1d).
5.3.1.5 Restoration set installation alarm
By checking the integrity of combination of the drive unit and the restoration set
and removing the restoration set during the infusion process, check whether it
meets the requirements of 4.2.1e).
5.3.2 Prompt sound pressure level test of the infusion pump for
ambulatory use
Place the infusion pump for ambulatory use and the sound level meter in a free
field environment at a height of 1.5 m above the reflecting surface; the
Input purified water of nominal volume into the restoration set, which shall pass
the tightness test; the result shall meet the requirements of 4.3.1.7.
5.4.1.8 Residual amount of liquid medicine
The residual amount of liquid medicine in the restoration set and restoration line
shall be the volume of the restoration minus the nominal volume; the result shall
meet the requirements of 4.3.1.8.
5.4.2 Chemical properties
The preparation of the test solution of 5.4.2.1 ~ 5.4.2.5 is in accordance with
the method of "Serial No. 5" in Table 1 of GB/T 14233.1-2008.
5.4.2.1 Reducing substances
Perform the test according to the provisions in 5.2.2 of GB/T 14233.1-2008,
which shall meet the requirements of 4.3.2.1.
5.4.2.2 Metal ions
Perform the test according to the provisions in 5.6.1 of GB/T 14233.1-2008,
which shall meet the requirements of 4.3.2.2.
5.4.2.3 pH value
Perform the test according to the provisions in 5.4.2 of GB/T 14233.1-2008,
which shall meet the requirements of 4.3.2.3.
5.4.2.4 Evaporation residue
Perform the test according to the provisions in GB/T 14233.1-2008, which shall
meet the requirements of 4.3.2.4.
5.4.2.5 UV absorbance
Perform the test according to the provisions in GB/T 14233.1-2008, which shall
meet the requirements of 4.3.2.5.
5.4.2.6 Residue of ethylene oxide
Take samples from the restoration set; perform the test according to the
provisions in GB/T 14233.1-2008, which shall meet the requirements of 4.3.2.6.
5.4.3 Sterile and pyrogen-free
Perform the test according to the provisions in GB/T 14233.2-2005.
5.4.4 Biological evaluation
Appendix A
(Informative)
Guidelines and compilation instructions
A.1 Guidelines
A.1.1 Relationship with GB 9706.27-2005
GB 9706.27-2005 is a special safety standard for infusion pumps, which
stipulates the basic safety and basic performance of infusion pumps, and is also
one of the important bases for the formulation of this Standard. The infusion
pumps that are specified in GB 9706.27-2005 contain a wide range of types.
There are differences in the application and even test methods of different types
of infusion pumps in the standard; therefore, when developing this Standard,
the safety and performance terms for the infusion pump in the special safety
standards are considered, so as to make specific requirements.
The working data accuracy of Chapter 50 in GB 9706.27-2005 only stipulates
the test method. Considering the diversity of infusion pumps, there is no specific
requirement for infusion accuracy. This Standard proposes the minimum index
for infusion accuracy for specific clinical applications.
Still, some indicators in GB 9706.27-2005 only specifies the performance
parameters that the manufacturer shall declare in the random file, such as the
accuracy of the blocking pressure, the bolus volume that is generated by the
blocking, and the normal operating time of the internal power supply; these
parameters shall be a part of the performance of the infusion pump; so, it is
necessary to extract in this Standard and put forward appropriate indicators to
regulate the development of the industry of infusion pump for ambulatory use.
Another important point of this Standard is to provide specific indicators for the
alarm system of infusion pump for ambulatory use. Because it is clear in 51.106
audible and visual alarms of GB 9706.27-2005 that the infusion pump for
ambulatory use may not have audible alarms; but in clinical use, if the infusion
pump for ambulatory use only has visual alarms, it is not enough to achieve the
expected alarm effect, and there are safety risks. Therefore, the audible alarm
is added to this Standard; and the revision of the alarm is quoted according to
the newly released IEC 60601-2-24.
A.1.2 Relationship with YY 0451-2010
YY 0451-2010 is an industry standard that is formulated for non-electrically
driven single-use infusion pump for ambulatory use, which includes
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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