YY 0451-2023_English: PDF (YY0451-2023)
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Portable infusion devices for single use - Non electrically driven
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Standards related to: YY 0451-2023
| Standard ID | YY 0451-2023 (YY0451-2023) | | Description (Translated English) | Portable infusion devices for single use - Non electrically driven | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 18,145 | | Date of Issue | 2023-09-05 | | Date of Implementation | 2026-09-15 | | Older Standard (superseded by this standard) | YY 0451-2010 | | Administrative Organization | National Technical Committee on Standardization of Medical Infusion Equipment (SAC/TC 106) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the basic requirements and corresponding test methods for disposable portable infusion pumps - non-electrically driven (hereinafter referred to as infusion pumps). This standard applies to infusion pumps for continuous (fixed or adjustable) and/or self-controlled delivery of fluids for neurological, intravascular or subcutaneous applications. This document does not apply to: electric or electronically controlled infusion pumps covered by GB 9706.224; devices for single patient use for delivering discrete (bolus) medicinal liquids covered by the YY/T 1768 series; implantable devices; intestinal Feeding pump; transcutaneous infusion device; device in which infusion power is not provided by the device itself or obtained by active intervention of the patient (for example, a device powered only by gravity). | YY 0451-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
CCS C 47
Replacing YY 0451-2010
Portable Infusion Devices for Single Use - Non Electrically
Driven
(ISO 28620:2020, Medical Devices - Non-electrically Driven Portable Infusion
Devices, MOD)
ISSUED ON: SEPTEMBER 5, 2023
IMPLEMENTED ON: SEPTEMBER 15, 2026
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative References ... 6
3 Terms and Definitions ... 7
4 General Requirements ... 9
5 Operating Requirements ... 12
6 Test Methods ... 12
7 Information That Shall Be on the Packaging and / or Product ... 17
8 Accompanying Documents ... 18
Appendix A (informative) Technical Differences between This Document and ISO
28620:2020, and Causes for the Differences ... 19
Appendix B (normative) Particulate Pollution Test ... 22
Bibliography ... 25
Portable Infusion Devices for Single Use - Non Electrically
Driven
1 Scope
This document specifies the basic requirements and corresponding test methods for portable
infusion devices for single use - non electrically driven (hereinafter referred to as the infusion
devices).
This document is applicable to infusion devices for continuous (fixed or adjustable) and / or
self-controlled delivery of fluids for neurological, intravascular or subcutaneous applications.
NOTE: the parts of neurological application include the spine, intrathecal or subarachnoid space,
ventricles, epidural space, epidural space or dural space. Neurological anesthetics can be
locally infused to affect large parts (for example, limbs) of the body and involve nerve
plexus blocks (for example, brachial plexus block or single nerve block). The neurological
application procedure involves a continuous infusion of local anesthetic into the wound.
This document does not apply to:
---Electrically driven or electrically controlled infusion devices covered by GB 9706.224;
---Devices for the delivery of discrete (bolus) medicinal liquids covered by the YY/T 1768
series for use by a single patient;
---Implanted devices;
---Enteral feeding pumps;
---Transcutaneous infusion devices;
---Devices whose infusion is not driven by the devices themselves or devices whose
infusion is driven by active intervention by the patient (for example, devices powered
solely by gravity).
2 Normative References
The contents of the following documents constitute indispensable clauses of this document
through normative references in the text. In terms of references with a specified date, only
versions with a specified date are applicable to this document. In terms of references without a
specified date, the latest version (including all the modifications) is applicable to this document.
GB/T 6682 Water for Analytical Laboratory Use - Specification and Test Methods (GB/T 6682-
2008, ISO 3696:1987, MOD)
GB 8368 Infusion Sets for Single Use - Gravity Feed (GB 8368-2018, ISO 8536-4:2010, MOD)
GB/T 14233.1-2022 Test Methods for Infusion, Transfusion, Injection Equipment for Medical
Use - Part 1: Chemical Analysis Methods
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within
a Risk Management Process (GB/T 16886.1-2022, ISO 10993-1:2018, IDT)
YY 0286.1-2019 Infusion Sets for Special Purpose - Part 1: Infusion Sets for Single Use with
Micropore Filters
YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling
and Information to be Supplied - Part 1: General Requirements (YY/T 0466.1-2016, ISO
15223-1:2012, IDT)
YY/T 0916.1 Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part
1: General Requirements (YY/T 0916.1-2021, ISO 80369-1:2018, IDT)
YY/T 0916.6 Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part
6: Connectors for Neuraxial Applications (YY/T 0916.6-2022, ISO 80369-6:2016, IDT)
ISO 80369-7 Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part 7:
Connectors for Intravascular or Hypodermic Applications1)
3 Terms and Definitions
The following terms and definitions are applicable to this document.
3.1 bolus
Input a certain volume of medicinal fluid in a short time.
3.2 bolus refill time
The time required to refill an empty bolus device to the bolus volume.
3.3 nominal bolus refill time
The bolus refill time (3.2) marked on the infusion device or its packaging.
3.4 filling volume
The nominal volume (3.10) plus the residual volume (3.5).
3.5 residual volume
After the infusion is completed, the volume of residual fluid in the infusion device and its
1) YY/T 0916.7, which equivalently adopts ISO 80369-7:2021, is about to be issued.
4 General Requirements
4.1 Composition
The infusion device shall include the following components:
---Non-electrical energy-driven component for the infusion of medicinal fluids;
---Flow-limiting device;
---Liquid storage bag used to hold infused medicinal fluids;
---Medicinal fluid filter on the medicinal liquid infusion channel.
NOTE 1: these components are either integral or separated.
The infusion device may also include one or more of the following components (non-exhaustive
list):
---Flow regulating system;
---Liquid filling port, preferably equipped with an anti-backflow valve;
NOTE 2: the liquid filling port is only used for filling medicinal fluids and shall comply with the
female Luer connectors in YY/T 0916.7.
---The end of the pipeline complies with the locking connectors in YY/T 0916.6 or YY/T
0916.7, so as to satisfy the requirements for the intended use;
---Flow-stop clamp, if necessary;
---Sterile protective sleeves, for example, Luer caps, on the end of the pipeline and the
filling port;
---An infusion system that performs bolus within the infusion time range in a mode of
controlling the maximum infusion volume;
---Protective device for the liquid storage bag, so as to prevent the medicinal liquids from
flowing out when the liquid storage bag ruptures or leaks (shall satisfy the leakage test
of 6.5 and 6.6);
---The mode, in which, the end point of infusion is indicated;
NOTE 3: achieved through visual, auditory or other prompts.
---Infusion pipeline;
---Exhaust device.
4.2 Materials
The materials used in parts that come into contact with medicinal liquids shall undergo
biological evaluation in accordance with the relevant parts of GB/T 16886.1.
4.3 Design and Characteristics
4.3.1 General principle
The infusion device shall be designed to deliver in accordance with the nominal flow rate (5.1).
4.3.2 Connectors
If applicable, the connectors of the liquid filling port shall comply with the female locking
connectors in YY/T 0916.6 or YY/T 0916.7.
If connectors are used at the end of the pipeline, they shall comply with the male locking
connectors in YY/T 0916.6 or YY/T 0916.7, so as to satisfy the requirements for the intended
use.
All connectors on the infusion device used to connect to other medical devices or accessories
shall be designed in accordance with YY/T 0916.1, YY/T 0916.6 or YY/T 0916.7, so as to
satisfy the requirements for the intended use.
NOTE: YY/T 0916.6 and YY/T 0916.7 specify the materials, dimensional design and performance
requirements for the connectors. On the premise that the materials and designed
dimensions of the connectors satisfy the corresponding standards, the connectors are
generally considered to comply with the requirements for non-interconnection
characteristics in YY/T 0916.1, then, they will only be tested in accordance with the
performance requirements in YY/T 0916.6 or YY/T 0916.7.
4.3.3 Filters
The system liquid path shall be equipped with a filter with a nominal bore less than or equal to
5 m and shall comply with the requirements for particulate pollution and filtration
performance of medicinal liquids in YY 0286.1-2019.
4.3.4 Pipeline
The infusion devices may be designed so that their pipeline is integral or separated. If the
pipeline is separated, the system connected to the infusion devices shall use locking connectors.
When tested in accordance with 6.4, the connection between the liquid storage bag and the
pipeline shall be able to withstand a static tensile force of 15 N for 15 seconds.
4.3.5 Liquid storage bag
All components on the infusion devices that come into contact with the medicinal liquids shall
constitute a closed and leak-free system. This requirement can be verified by the test methods
4.5.5 Evaporation residue
Test in accordance with the method of 5.5 in GB/T 14233.1-2022. The total amount of
evaporation residue shall not exceed 2 mg.
4.5.6 UV absorbance
In accordance with the stipulations of 5.7 in GB/T 14233.1-2022, within 220 nm ~ 360 nm,
carry out the test, and the absorbance of the test solution shall not be greater than 0.3.
4.5.7 Residue of ethylene oxide
When cutting a sample from the liquid storage bag and testing in accordance with Chapter 9 in
GB/T 14233.1-2022, the residue of ethylene oxide shall not exceed 10 g/g.
5 Operating Requirements
5.1 Flow Rate
The nominal flow rate of the infusion device shall be calibrated with a quality control solution
at a given temperature. The nominal flow rate and the quality control solution and this
temperature shall be specified in the instructions for use accompanying the infusion device [see
8c] and 8g)].
When tested in accordance with 6.2, the average flow rate shall be within the 15% deviation
range of the nominal flow rate, and the adjustable flow rate shall be within the 20% deviation
range of the nominal flow rate. The instantaneous flow rate of at least 80% of the nominal
volume shall be supplied within 50% deviation range of the nominal flow rate.
NOTE: if the infusion device is exposed to external pressure, the instantaneous flow rate may
deviate by more than 50% of the nominal flow rate.
5.2 Bolus (if applicable)
When tested in accordance with 6.7, the bolus volume shall not exceed 115% of the nominal
bolus volume.
When tested in accordance with Test 1 in 6.8, during the nominal bolus refill time, trigger the
bolus device, and the bolus volume shall be within 50% ~ 115% of the nominal bolus volume.
When tested in accordance with Test 2 in 6.8, at 50% of the nominal bolus refill time, trigger
the bolus device, and the bolus volume shall be less than 75% of the nominal bolus volume.
6 Test Methods
6.1 Test Conditions
6.1.1 General
Unless otherwise specified, the following stipulations are universal and applicable before each
test.
6.1.2 Instruments and materials
6.1.2.1 Needle
The specifications of the needle are specified by the manufacturer. If the manufacturer does not
specify the specifications, use a needle with an inner diameter of not less than 1.2 mm.
6.1.2.2 Quality control solutions
Quality control solutions recommended by the manufacturer and listed in the accompanying
documents shall be used (see Chapter 8).
6.1.3 Operating conditions
In accordance with the instructions for use and the accompany documents, prepare the infusion
device [see 8c)], so that it can infuse solution.
Fill the liquid storage bag with the filling volume of solution or the volume of solution specified
by the manufacturer.
In accordance with the conditions specified by the manufacturer, carry out the test. If there are
no stipulations, under the conditions of a temperature of (23 2) C, a relative humidity of (50
5) % and an atmospheric pressure of 86 kPa ~ 106 kPa, the longitudinal axis of the liquid
storage bag and the end outlet are at the same level.
NOTE: in tests not affected by atmospheric pressure, the limitation of the atmospheric pressure can
be ignored.
6.2 Determination of Flow Rate
6.2.1 Principle
The purpose of this test is to confirm that during the entire process of solution infusion, the
difference among the average flow rate, instantaneous flow rate and nominal flow rate remains
within the deviation range specified in Chapter 5.
6.2.2 Instrument
The components of the instrument are shown in Figure 1. Unless otherwise specified by the
manufacturer, A and B shall be on the same horizontal line.
After the test, the infusion device shall pass the leakage test specified in 6.6.
6.5 Drop Test
Fill the infusion device with the staining solution of the filling volume. After carrying out the
pressure resistance test in 6.3 and the tensile strength test in 6.4, drop twice from a height of 1
m onto a thick hardwood board (for example, greater than 600 kg/m3). The first time, it falls
along the long axis, and the second, it falls along the direction perpendicular to the long axis.
NOTE: the applicable solution is a solution containing 20 mg/L Patent Blue V2) or other equivalent
staining solution.
After the test, the infusion device shall pass the leakage test specified in 6.6.
6.6 Leakage Test of Various Components of Infusion Device
Other methods equivalent to the method described below may also be used.
After performing the drop test, immerse the infusion device in a container filled with water for
5 minutes. For this test method, each manufacturer shall perform test method validation, so as
to ensure that the test parameters are suitable for the specific device.
NOTE: the applicable solution is a solution containing 20 mg/L Patent Blue V or other equivalent
staining solution.
If applicable, seal the air filter or leave it out of the water.
Under the above-mentioned test conditions, the infusion device shall maintain its sealing. In
other words, the solution in the container shall not change color.
6.7 Bolus Volume
6.7.1 In accordance with the requirements of 6.1.3, prepare the infusion device.
6.7.2 Use 2 times the nominal bolus refill time to fill the liquid storage bag of bolus. For
example, if the refill time of the infusion device is 60 minutes, then, allow at least 120 minutes
to fill the liquid storage bag of bolus.
6.7.3 In accordance with the manufacturer’s instructions, trigger the bolus device and measure
the output volume.
6.7.4 For the same infusion device, at the nominal volume of the liquid storage bag, measure
once, then, at an output of approximately 50% of the nominal volume, repeat the measurement
twice. Calculate the average value of the output volume measured three times.
2) E131 Patent Blue V is defined as follows: Patent Blue V is mainly composed of [4-(α-(4-diethylaminophenyl)-5-
hydroxy-2,4-disulfophenylmethylene)-2,5-cyclohexadiene-1-subunit] sodium salt or calcium salt of diethyl
ammonium hydroxide inner salt and accessory colorants, with uncolored sodium chloride and / or sodium sulfate
and / or calcium sulfate as the main ingredients. Potassium salts may also be used; category: triarylmethane. Color
index number: 42051. Einecs: 222-573-8.
Appendix B
(normative)
Particulate Pollution Test3)
B.1 Principle
By rinsing the surface of the liquid channel in the inner cavity of the infusion device, collect
particles on the filter membrane, and use a microscope to count them.
B.2 Reagents and Materials
B.2.1 Distilled water, distilled water filtered through a membrane with a pore size of 0.2 m.
B.2.2 Powder-free gloves.
B.2.3 Filter membrane, 0.45 m.
B.2.4 Syringe.
B.2.5 Purification workbench, which complies with Level-N5 in GB/T 25915.1-2021.
B.3 Steps
B.3.1 Before the test, the test device, filter membrane, syringe and other equipment shall be
thoroughly cleaned with distilled water (B.2.1).
B.3.2 Take an infusion device, use a syringe (B.2.4) to fill the liquid storage bag of the infusion
device with the nominal volume of water, adopt an appropriate method to collect the eluent
from the liquid storage bag, and pass the eluent through a filter membrane (B.2.3).
NOTE: the eluent preparation method shall be designed on the premise that the eluent does not
pass through the medicinal liquid filter of the infusion device and the shortest elution time.
B.3.3 Use new distilled water and repeat B.3.1, until one infusion device uses a total of 500 mL
of distilled water (B.2.1) to rinse the inner cavity and pass all the eluent through a filter
membrane.
B.3.4 Repeat B.3.1 ~ B.3.2 on the other 9 infusion devices.
B.3.5 Place the grid filter membrane under a microscope (incident illumination) at 50
magnification and count in accordance with the size classification provided in Table B.1.
3) Test methods equivalent to the method in this Appendix may also be used, for example, using a particle counter
method instead of a microscope method to count particles. The method provided in this Appendix may not be
applicable to some devices with special structures.
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