YY/T 0286.4-2020 English PDF (YY/T0286.4-2020)

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YY/T 0286.4-2020: Special infusion sets -- Part 4: Infusion sets for single use with pressure infusion apparatus
YY/T 0286.4-2020
Special infusion sets - Part 4.Infusion sets for single use with pressure infusion apparatus
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Replace YY 0286.4-2006
Dedicated infusion set part 4.single use
Infusion set for pressure infusion equipment
(ISO 8536-8.2015,Infusionequipmentformedicaluse-Part 8.Infusion
2020-06-30 released
2021-06-01 implementation
Issued by the State Drug Administration
Preface
The "Special Infusion Set" series of standards consists of the following parts.
---YY 0286.1 One-time use microporous filter infusion set;
---YY 0286.2 One-time use burette type infusion set gravity infusion type;
---YY 0286.3 One-time use light-proof infusion set;
---YY/T 0286.4 Infusion set for disposable pressure infusion equipment;
---YY/T 0286.5 Disposable bottle type and bag type infusion set;
---YY/T 0286.6 One-time use scale flow regulating infusion set.
This part is part 4 of YY/T 0286.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0286.4-2006.Compared with YY 0286.4-2006, the main technical changes are as follows.
---The nature of the standard is changed from mandatory to recommended;
---Modified the degree of standard adoption, from "IDT" (equal adoption) to "MOD" (modification adoption);
---Updated normative reference documents (see Chapter 2, Chapter 2 of the.2006 edition);
--- Added Chapter 3 terms and definitions (see Chapter 3);
--- Delete the original Chapter 4 mark (Chapter 4 of the.2006 edition);
---Modified the pipeline requirements to be equivalent to the pipeline length requirements of ISO 8536-8 (see 6.11, 6.11 in the.2006 edition);
--- Modify the storage volume requirements, and add Appendix B storage volume test method (see 6.14,.2006 edition 6.14);
---Modified Chapter 10 labeling requirements (see Chapter 10, Chapter 10 of the.2006 edition);
---Added Chapter 11 disposal requirements (see Chapter 11);
--- Delete the test method A.4 of the original Appendix A (see A.4 of the.2006 edition);
--- Modified A.3 leak test method (see A.3,.2006 edition of A.3).
---Updated references.
This part adopts the redrafting method to amend and adopt ISO 8536-8.2015 "Medical infusion apparatus Part 8.Pressure infusion equipment for infusion
Liquidizer.
Compared with ISO 8536-8.2015, this part has technical differences. Appendix C is added after Appendix A and Appendix B, and the corresponding
A list of technical differences and their causes.
This section also made the following editorial changes.
---Informative Appendix C has been added, which gives a list of the corresponding technical differences and their reasons compared with ISO 8536-8.2015.
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This part was proposed by the State Drug Administration.
This part is under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices (SAC/TC106).
Drafting organizations of this section. Shandong Medical Device Product Quality Inspection Center, Terumo Medical Products (Hangzhou) Co., Ltd., Wuhan Zhixun
Chuangyuan Technology Development Co., Ltd., Jiangsu Yakai Medical Technology Co., Ltd., Shandong Xinhua Ande Medical Products Co., Ltd.
The main drafters of this section. Yao Xiujun, Wu Liqun, Liu Weijun, Wu Qiyu, Zhang Xianshun, Li Kanyuan.
The previous releases of this part are as follows.
---YY 0286.4-2006.
introduction
With the continuous development of infusion technology and the increasing clinical requirements, some special applications that can adapt to special clinical requirements have appeared one after another.
Infusion set, the "special infusion set" series of standards are used to standardize these special infusion sets. Since the development of infusion sets is endless, it is expected that
It is impossible to include all special infusion sets with special requirements in a standard. Therefore, the various standards of the "Special Infusion Set" series
Some of these special infusion sets are only regulated for a special clinical requirement. If a certain infusion set also belongs to multiple special infusion sets, it should be
At the same time implement the applicable part of YY 0286.
Appendix D in GB 8368 is applicable to this part.
Dedicated infusion set part 4.single use
Infusion set for pressure infusion equipment
1 Scope
This part of the "Special Infusion Set" series of standards specifies the sterile supply of disposable infusion equipment for pressures of.200kPa and below
Requirements for using an infusion set (hereinafter referred to as "infusion set").
This section applies to disposable infusion sets of infusion equipment with pressures of.200kPa and below.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 1962.2 Syringes, injection needles and other medical devices
The increased volume of the line volume (VS) after pressurization compared to the volume of the line without pressure (VF).
Note. The diagram of the pill volume is shown in Figure 1.
3.3
Storagevolume
VS
The volume of the pipeline under pressure, which is the sum of the filling volume (VF) and the pill volume (VB).
VS=VF VB
4 General requirements
4.1 The names of the infusion set components and separate air intake components are shown in Figure 2, Figure 3 and Figure 4.These illustrations show the infusion set and inlet
The structure of the gas device; as long as the same effect can be achieved, other structures can also be used. The infusion set shown in Figure 3 is suitable for bag-type plastic containers.
The infusion set shown in FIG. 3 with the separate air intake device shown in FIG. 4, or the infusion set shown in FIG. 2 is suitable for rigid containers.
4.2 The infusion set should have a protective cover to keep the inside of the infusion set sterile before use. The cork piercer or needle of the air intake device should have a protective cover.
5 materials
The materials for manufacturing the infusion set and its components given in Chapter 4 should meet the requirements of Chapter 6.The components of the infusion set in contact with the solution
The materials should also meet the requirements specified in Chapter 7 and Chapter 8.
6 Physical requirements
6.1 Particulate pollution
When testing according to A.1, GB 8368 is applicable.
6.2 Connection strength
When testing according to A.2, excluding the protective cover, the infusion set should be able to withstand a static tension of not less than 15N for 15s.
6.3 Leak
When testing according to A.3.2 and A.3.4, there should be no air and water leakage. When testing according to A.3.3, no air should enter.
6.4 External cone joint
The outer cone joint should meet the requirements of GB/T 1962.2.
6.5 Injection parts
The injection part should be able to inject into the pipeline. When testing according to A.4, the water leakage should not exceed one drop. The injection part should be located at the outer cone joint
annex.
6.6 Liquid chemical filter
GB 8368 applies.
6.7 Infusion flow rate
GB 8368 applies.
6.8 Cork piercer
GB 8368 applies.
6.9 Intake device
GB 8368 applies.
6.10 Drop Hopper and Dropper
GB 8368 applies.
6.11 Piping
The tubing made of soft material should be transparent or sufficiently transparent, when air bubbles pass through, you can distinguish water and air with normal or corrected vision
Interface.
The length of the pipe from the end to the drip hopper [including the injection part (if any) and the outer cone joint] should not be less than 1500mm.
6.12 Flow regulator
GB 8368 applies.
6.13 Protective sleeve
GB 8368 applies.
6.14 Storage volume
The volume of the storage liquid shall be stated in 10.2i). For the definition of storage volume and the test method for determining storage volume, see Appendix B.
7 Chemical requirements
GB 8368 applies.
8 Biological requirements
GB 8368 applies.
9 Packaging
GB 8368 applies.
10 tags
10.1 General
The label shall comply with the provisions of 10.2 and 10.3.If graphic symbols are used, see YY/T 0466.1.
The substance of concern is drawn with a cross on its symbol.
10.2 Single package
The single package should have at least the following information.
a) The name and address of the manufacturer;
b) Text description of the contents;
c) Indicate that the infusion set is pyrogen-free, or the infusion set is free of bacterial endotoxin;
d) Use the graphic symbols given in YY/T 0466.1 to indicate that the infusion set is sterile;
e) Lot number, start with the word "LOT", or use the graphic symbols specified in YY/T 0466.1;
f) Expiration date (year and month), with appropriate text, or use graphical symbols in accordance with YY/T 0466.1;
g) Indicate that the infusion set is for one-time use only, or equivalent text, or use graphic symbols that comply with YY/T 0466.1;
h) Instructions for use, including warnings, such as about the protective cover falling off (the instructions for use can also be in the form of inserts);
i) The volume of the liquid storage is marked according to B.3.If a matching pressure infusion device is specified, the manufacturer shall give the pressure infusion device
Name and type;
j) The letter "p" that represents pressure should stand out from the surrounding text;
k) Instructions that 20 drops or 60 drops of distilled water from the dropper are equal to (1±0.1) mL or (1±0.1) g.
If the single package area is too small to give all the information and/or symbols, the information can be simplified to e) and f). In this case, this article
The required information needs to be given on the label of the next larger shelf or multi-unit package.
10.3 Shelf or multi-unit packaging
The shelf or multi-unit packaging should have at least the following information.
a) The name and address of the manufacturer;
b) Text description of the contents;
c) Lot number, start with the word "LOT", or use the graphic symbols specified in YY/T 0466.1;
d) Expiration date (year and month), with appropriate text, or use graphical symbols in accordance with YY/T 0466.1;
e) Instructions for use, including warnings, such as about the protective cover falling off (the instructions for use can also be in the form of inserts);
f) The letter "p" that represents pressure, its size should stand out from the surrounding text;
g) Storage requirements.
11 Disposal
Information on the safe and environmentally sound disposal of single-use infusion sets should be given in the accompanying documents.
Example.
"Be sure to use methods that comply with established biohazard-free disposal procedures to dispose of blood-contaminated products" or equivalent text.
Appendix A
(Normative appendix)
Physical test
A.1 Particulate pollution test
GB 8368 applies.
A.2 Connection strength test
Make the test infusion set bear a 15N axial static tension for 15s. Check whether the infusion set can withstand the applied force.
A.3 Leak test
A.3.1 At the beginning of the test, adjust the state of the entire system at the test temperature.
A.3.2 Connect the infusion set to the air source, seal the other ports, and fill the infusion set with 50kPa air pressure at (40±1)℃ for 15s,
Place the infusion set in water and check for gas leaks.
A.3.3 Fill the infusion set with water, seal each port, connect it with a vacuum device, vacuumize to -20kPa at (40±1)℃, keep it
15s. Check whether gas enters the infusion set.
If the infusion set has a flow element, the test is only applicable to the part above the flow element of the infusion set; if there is no flow element, the test is applicable to
The entire infusion set.
A.3.4 Apply a pressure of.200kPa to the flow element of the infusion set and the water-filled part below, in an environment of (40±1)℃, for 15min.
If the supporting pressure infusion equipment is specified, the maximum working pressure of the pressure infusion equipment shall be applied.
Note. If the infusion set has no flow components, under the same environment, check the entire pipeline under the drip hopper.
A.4 Injection test
Test according to GB 8368, but under.200kPa internal pressure.
A.5 Filtration rate test of chemical liquid filter
GB 8368 applies.
Appendix B
(Normative appendix)
Storage volume
B.1 General
This appendix explains the different measurable pipe volumes and the test methods for measuring each volume through clear definitions.
B.2 Measurement of pipeline volume
B.2.1 Filling volume (VF)
Calculate the filling volume per meter of pipeline according to formula (B.1). The calculation result is affected by the nominal inner diameter of the pipeline.
VF=
d2×π
4 ×l
(B.1)
Where.
VF --- the filling volume per meter of pipe length, in milliliters (mL);
d --- The nominal inner diameter of the pipeline, in centimeters (cm);
l ----100 centimeters of pipeline length, in centimeters (cm).
B.2.2 Pill volume (VB)
B.2.2.1 General
It is difficult to calculate the pill volume only by considering the various variables (for example, inner diameter, wall thickness, tube hardness, temperature influence).
Therefore, determine the pill volume according to the following test conditions (see Figure B.1).
---Indoor temperature (23±2)℃;
---Distilled water as the test medium, the temperature of the test medium is (40±1)℃;
---The internal pressure is.200kPa, and the pressure lasts for 15s;
---All test samples are already in use, for example, sterile;
---.2000mm length pipeline with additional connecting parts;
---For "rigid" connectors, the volume change is zero under pressure.