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YY/T 0286.6-2020

Chinese Standard: 'YY/T 0286.6-2020'
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YY/T 0286.6-2020English259 Add to Cart Days<=3 Special infusion sets--Part 6: Infusion sets for single use with graduated flow regulator Valid YY/T 0286.6-2020
YY/T 0286.6-2020Chinese17 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YYT0286.6-2020 (YYT0286.6-2020)
Description (Translated English) Special infusion sets--Part 6: Infusion sets for single use with graduated flow regulator
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C31
Classification of International Standard 11.040.20
Word Count Estimation 13,193
Date of Issue 2020-03-31
Date of Implementation 2021-04-01
Older Standard (superseded by this standard) YY 0286.6-2009
Drafting Organization Shandong Weigao Group Medical Polymer Products Co., Ltd., Shandong Medical Device Product Quality Inspection Center, Baxter Medical Supplies Trading (Shanghai) Co., Ltd., Shandong Xinhua Ande Medical Supplies Co., Ltd.
Administrative Organization National Technical Committee for Standardization of Medical Infusion Apparatus (SAC / TC 106)
Regulation (derived from) Announcement No. 48 of 2020 by the State Administration of Drug Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY/T 0286.6-2020
Special infusion sets--Part 6.Infusion sets for single use with graduated flow regulator
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Replace YY 0286.6-2009
Dedicated infusion set
Part 6.One-time use of scale flow
Adjustable infusion set
2020-03-31 released
Implementation on 2021-04-01
Issued by the State Drug Administration
Preface
YY/T 0286 "Special infusion set" includes the following parts.
---Part 1.Disposable microporous filter infusion set;
---Part 2.Gravity infusion of disposable burette infusion set;
---Part 3.Disposable light-proof infusion set;
---Part 4.Infusion sets for disposable pressure infusion equipment;
---Part 5.Disposable bottle type and bag type infusion set;
---Part 6.One-time use scale flow regulating infusion set.
This part is part 6 of YY/T 0286.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0286.6-2009 "Special infusion set Part 6.One-time use flow setting fine-tuning infusion set", and
Compared with YY 0286.6-2009, the main technical changes except for editorial changes are as follows.
---Added terms and definitions (see Chapter 3);
---Added the schematic diagram of the scale flow regulator (see Figure 2);
---Reliability requirements are modified (see 6.2.1);
---Modified the performance requirements for infusion flow rate (see 6.3);
---Modified the performance requirements of the stop clamp or switch (see 6.4);
---Added the leakage test of the infusion set (see 6.5);
---Modified the single package mark (see 9.2);
---Modified the flow control characteristic test method (see Appendix A);
---Added the leakage test method of the infusion set (see Appendix B);
---Added references.
This part uses the redrafting method to refer to ISO 8536-13.2016 ``Liquid contact single-use scaled flow regulators''.
The degree of consistency with ISO 8536-13.2016 "Liquid contact single-use scaled flow regulator" is not equivalent.
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 Weigao Group Medical Polymer Products Co., Ltd., Shandong Medical Device Product Quality Inspection
Xin, Baxter Medical Products Trading (Shanghai) Co., Ltd., Shandong Xinhua Ande Medical Products Co., Ltd.
The main drafters of this section. Li Weiyang, Gao Na, Liu Juanhua, Sun Shouyu, Wang Xiuxiu, Zhang Xiang.
The previous releases of YY/T 0286.6 are as follows.
---YY 0286.6-2009.
introduction
With the continuous development of infusion technology and the increasing clinical requirements, some infusions that can be adapted to special clinical requirements have been produced.
Device. Since the development of products is endless, it is impossible to expect all infusion sets with special requirements to be included in a standard
of. Therefore, each part of "Special Infusion Sets" only regulates these special infusion sets for a certain clinical special requirement. Some dedicated input
The infusion set may also belong to a variety of special infusion sets, and at the same time implement the applicable part of the "special infusion set".
In some special applications, it is required to control the infusion flow rate stably. The scale flow regulating infusion set is to meet this
Specially designed for the requirements of clinical applications. Compared with ordinary flow regulators, the scale flow regulator of this infusion set has the advantage of being able to
Keep the flow stable and realize the flow setting according to the scale.
Appendix D in GB 8368 is applicable to this part.
Dedicated infusion set
Part 6.One-time use of scale flow
Adjustable infusion set
1 Scope
This part of YY/T 0286 specifies the single-use infusion set used for gravity infusion and can achieve scale flow adjustment (hereinafter abbreviated
Called the infusion set) to ensure compatibility with other intravenous infusion devices.
This section applies to single-use infusion sets that mark the scale numbers on the scale flow adjustment device and are used for gravity infusion.
This section does not apply to infusion sets that are not marked with scale numbers on the scale flow adjustment device.
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 8368 single-use infusion set gravity infusion type (GB 8368-2018, ISO 8536-4.2010/AMD1.2013,
MOD)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Scale flow regulator
The components that are in contact with the liquid medicine with scale marks and can set the flow rate according to the scale.
3.2
Scale
A series of identifications and corresponding identification numbers related to the position of the observed indicator.
4 General requirements
4.1 The infusion set and scale flow regulator are shown in Figure 1 and Figure 2.
Note. Figure 1 shows an air intake infusion set, it can also be a non air intake infusion set, see GB 8368.Figure 1 and Figure 2 are not unique, as long as the same effect can be achieved
As a result, other configurations can also be used.
4.2 The infusion set should have a protective cover to keep the inner cavity 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 liquid
The materials should also meet the requirements specified in Chapter 7 and Chapter 8.
6 Physical requirements
6.1 General
The physical requirements of the infusion set should meet the requirements of GB 8368 (except for the requirements of leakage, flow regulator and infusion flow rate).
6.2 Scale flow regulator
6.2.1 Reliability
The infusion set is free to fall on a thick hardwood board at a height of 1m, and the two ends of the scale flow regulator are subjected to 15N for 15s along the pipeline.
The infusion set bears 0.5m and 1.5m hydrostatic pressure respectively, and each lasts for 10s. Check the scale flow regulator, the scale indication is not
Changes have occurred and the settings are stable and reliable. After the above test is completed, the infusion set should meet the requirements of 6.2.4 and 6.5.
6.2.2 Continuously adjustable
The scale flow regulator should be able to continuously adjust from zero ("off" position) to smooth flow ("on" position).
6.2.3 Indexing and marking
6.2.3.1 The text on the scale flow regulator should be in Chinese (except for "OPEN" and "OFF"), otherwise, it should be added on the single package
Description.
6.2.3.2 The scaled flow regulator should clearly indicate "open" or "OPEN", "close" or "OFF" at the open and closed positions, and clearly indicate the flow rate
unit. The flow rate should be scaled in milliliters per hour (mL/h).
6.2.4 Flow control characteristics
6.2.4.1 Flow rate indication error
The error of the flow rate (indicated by relative error) should be clearly indicated on the single package or on the accompanying documents. According to A.3 of Appendix A
During the test, the error of the flow rate indication at each test point should conform to the manufacturer's stated value [see 9.2.1c)].
Note. A uniform error can be given for all scales, or different errors can be given for different areas.
6.2.4.2 Flow control stability
When testing in accordance with Appendix A.4, the maximum number of graduations, the minimum number of graduations and the number of intermediate graduations in the range of 20mL/h~125mL/h are appropriate
The flow stability at any point should not exceed 10%.
6.3 Infusion flow rate
According to GB 8368, the infusion set with the scale flow regulator set in the "on" state outputs sodium chloride solution [mass concentration is ρ(NaCl)=
9g/L] should not be less than 500mL.
Note. For the infusion flow rate of the infusion set with sterile grade liquid filter, please refer to YY 0286.1.
6.4 Stop clamp or switch (if any)
Close the stop clip or switch, immerse the infusion set in (40±1)℃ water, and apply a pressure of 50kPa higher than atmospheric pressure from the inside of the infusion set.
Keep the air pressure for 15s, check if there is air leakage at the other end.
6.5 Leak
When tested in accordance with Appendix B, there should be no leakage.
7 Chemical requirements
GB 8368 applies.
8 Biological requirements
GB 8368 applies.
9 signs
9.1 General
GB 8368 applies.
9.2 Single package mark
9.2.1 In addition to complying with the provisions of GB 8368, the single package should also provide the following information.
a) "The scale indication is only an approximate value and should be corrected by the number of drops" or similar words;
b) The Chinese description of the special text on the scale flow regulator (if any, see 6.2.3.1);
c) The indication error of static head height and flow rate (see 6.2.4.1);
d) Description of exhaust method during adjustment (if necessary);
e) Other necessary information, such as instructions for use, etc.
9.2.2 The unit of measurement on the package should adopt the International System of Units.
10 packaging
GB 8368 applies.
11 Disposal
Information on the safe and environmentally sound disposal of single-use infusion sets should be provided in the accompanying documents, such as "must be used in accordance with the established
"No biohazard disposal procedures for the disposal of blood-contaminated products" or equivalent text.
Appendix A
(Normative appendix)
Flow control characteristic test method
A.1 Instruments and reagents
A.1.1 Balance, accurate to 0.01g.
A.1.2 The rigid test container (applicable to the air inlet infusion set) as shown in Figure A.1 or the constant as shown in Figure A.2 is filled with the test solution (A.1.5)
Liquid level test container (applicable to non-air infusion set).
A.1.3 6 liquid storage containers, equipped with devices to avoid liquid evaporation.
A.1.4 Timer.
A.1.5 Test solution, sodium chloride solution [mass concentration ρ(NaCl)=9g/L].
A.2 Test preparation
Take 6 infusion sets and adjust them for at least 2h under the test condition of (23±2)℃. Operate each input according to the instructions provided by the manufacturer
Liquid container. The height of the static pressure head is based on the value indicated on the package or attached documents. If there is no indication, it is 1m. For air intake infusion sets, static
The height of the indenter is shown in Figure A.1.For the non-air-injection infusion set, use the constant liquid level test container shown in Figure A.2 to test the static head height as
As shown in Figure A.2.
A.3 Flow error
A.3.1 Take three infusion sets and connect them to the infusion container (A.1.2), and set the scale flow regulators to low, medium and high.
The digital scale makes it in the infusion state.
A.3.2 Make the effluent flow into the liquid storage container (A.1.3) under the specified static pressure head, close the infusion set after 1h, measure by weighing and record for 1h
The volume of liquid collected in the liquid storage container, see formula (A.1).
Note. The smallest scale marked with a number refers to the scale marked with a number within the specified range that is closest to 20mL/h, and the largest scale marked with a number refers to the scale within the specified range
The scale marked with numbers closest to 125mL/h, the scale marked with numbers in the middle refers to the scale marked with numbers closest to 72.5mL/h.
A.4.2 Connect the three infusion sets to the infusion container (A.1.2), set the scale flow regulators at the three test points, and press
Use instructions to operate each infusion set to make it in infusion state.
A.4.3 Under the specified static pressure head, start the test after 15 minutes of stable operation, and continue the test for 6 hours. Use the weighing method to measure and record each small
The volume collected at time (Vi).
A.4.4 The relative deviation of the measured volume calculated by formula (A.2) represents the stability of the flow.
Appendix B
(Normative appendix)
Infusion set leak test
B.1 Before the start of the test, adjust the state of the infusion set at the test temperature.
B.2 Follow the instructions provided by the manufacturer.
B.3 Set the scale flow regulator to the "on" position and connect one end of the infusion set to a compressed air source. Close the other end of the infusion set,
Immerse in (40±1)℃ water, apply pressure 50kPa higher than atmospheric pressure to the inside of the infusion set for 15s, and check whether the infusion set is free
No leakage, and repeat the test on the scale with the maximum scale value of 25%, 50% and 75% of the scale flow regulator closest to the number marked.
B.4 Set the scale flow regulator to the "off" position, connect one end of the infusion set to the compressed air source and open the other end. Dip the infusion set
Into the water at (40±1)℃, apply a pressure of 50kPa higher than the atmospheric pressure to the inside of the infusion set for 15s. Check the open end of the infusion set
Are there any leaks. Finally, close the open end of the pipeline, keep the test sample at a pressure of 50kPa higher than the atmospheric pressure for 15s, and check
Check the scale flow regulator for any air leakage.
B.5 Set the scale flow regulator to the "on" position, and fill the infusion set with debubbled distilled water; one end of the infusion set is sealed, and the other end is connected
Connect to the vacuum device, apply a pressure of -20kPa to the inside at (40±1)℃ for 15s to check whether air enters the infusion set. On the scale
The flow regulator is set in the "off" position, and the maximum scale values of 25%, 50% and 75% are closest to the scale marked with numbers and repeat the test.
references
Related standard:   YY 0286.1-2019  YY 0286.3-2017
Related PDF sample:   YY 0286.3-2017  YY 0285.5-2018
   
 
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