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YY/T 0321.3-2022 PDF in English


YY/T 0321.3-2022 (YY/T0321.3-2022, YYT 0321.3-2022, YYT0321.3-2022)
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YY/T 0321.3-2022: PDF in English (YYT 0321.3-2022)

YY/T 0321.3-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing YY 0321.3-2009
Single-use filter for anaesthesia
ISSUED ON: AUGUST 17, 2022
IMPLEMENTED ON: SEPTEMBER 01, 2023
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Classification and labeling ... 6
4 Materials ... 8
5 Physical properties ... 8
6 Chemical properties ... 9
7 Biological properties ... 10
8 Marking ... 10
9 Packaging ... 11
10 Transportation and storage ... 12
Appendix A (Normative) Physical test ... 13
Appendix B (Normative) Preparation method of test solution for chemical properties
... 16
References ... 17
Single-use filter for anaesthesia
1 Scope
This part of YY/T 0321 specifies the classification and labeling, materials, physical
properties, chemical properties, biological properties, marking, packaging,
transportation and storage of single-use filter for anesthesia.
This Part applies to single-use filter for anesthesia (hereinafter referred to as filter),
which is a component of single-use puncture set local anaesthesia.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies to this document. For
undated references, the latest edition (including any amendment) applies to this
document.
GB/T 1962.1, Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 1: General requirement
GB/T 1962.2, Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 2: Lock fittings
GB/T 6682, Water for analytical laboratory use - Specification and test methods
GB/T 14233.1-2008, Test methods for infusion, transfusion, injection equipment for
medical use - Part 1: Chemical analysis methods
GB/T 14233.2, Test methods for infusion, transfusion, injection equipment for
medical use - Part 2: Biological test methods
GB/T 16886.1, Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process
YY/T 0313, Medical polymer products - Requirement for package and information
supplied by manufacturer
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 0929.1-2014, Sterilizing-grade filters for medical infusion equipment - Part 1:
Integrity test for fluid filters
AF-A-0.5
Example 2: A fluid filter with a nominal pore size for filtering medium of 0.22 μm:
AF-L-0.22
4 Materials
The filter should be made of suitable materials, and the filter made shall meet the
requirements of Chapters 5, 6 and 7.
5 Physical properties
5.1 Appearance
Observed with normal vision or corrected vision, the outer surface of the filter shall be
smooth and free of burrs, impurities, cracks and other defects.
5.2 Joints
Filter joints shall meet the requirements of GB/T 1962.1 and/or GB/T 1962.2.
5.3 Filtration performance requirements
5.3.1 Filtration performance requirements for fluid filters with a nominal pore size
of 2.0 μm
When testing according to A.1 in Appendix A, the filtration rate of the fluid medicine
filter shall not be less than 90%.
5.3.2 Filtration performance requirements for fluid filters with a nominal pore size
of 0.22 μm
The 0.22 μm fluid filter shall be tested according to the bubble point pressure test
method specified in Chapter 6 of YY/T 0929.1-2014.
Note: The 0.22 μm fluid filter shall meet the requirements of YY/T 0918 for bacterial
retention test. Due to the complexity of the bacterial retention test, it is generally
not suitable for routine inspection. Routine inspection can use the integrity test
for fluid filters specified in YY/T 0929.1, provided that the specified lower limit
of the bubble point pressure has established a relationship with the bacterial
retention test specified in YY/T 0918.
5.3.3 Air filter filtration performance requirements
When testing the air filter according to A.2, the filtration rate of particulates greater than
or equal to 0.5 μm in the air shall not be less than 90%.
5.4 Tightness
5.4.1 When the fluid filter is tested according to A.3.1, there shall be no liquid leakage.
5.4.2 When the air filter is tested according to A.3.2, there shall be no gas leakage.
5.5 Particle contamination
When the fluid filter is determined for particle contamination by the test in A.4 or other
equivalent methods, the number of particles ≥5.0 μm in the 60 mL eluent shall not
exceed 100/mL.
5.6 Liquid flow
5.6.1 Under the pressure of 300 kPa of fluid filter with a nominal pore size of 2.0 μm,
the 0.9% sodium chloride injection flowing through the fluid filter within 1 min shall
not be less than 200 mL.
5.6.2 Under the pressure of 300 kPa of fluid filter with a nominal pore size of 0.22 μm,
the 0.9% sodium chloride injection flowing through the fluid filter within 1 min shall
not be less than 100 mL.
6 Chemical properties
6.1 Preparation method of test solution
See Appendix B for the test solution preparation method.
6.2 Reducing substance (readily oxidizable substance)
When testing according to 5.2.2 in GB/T 14233.1-2008, the difference in the volume of
the potassium permanganate solution [c (KMnO4 = 0.002 mol/L] consumed by the test
solution and the blank solution shall not exceed 2.0 mL.
6.3 Metal ions
When testing according to 5.6.1 in GB/T 14233.1-2008, the color of the test solution
shall not exceed the standard control solution with a mass concentration ρ(Pb2+) = 1
μg/mL.
When using the atomic absorption spectrophotometry (AAS) in GB/T 14233.1-2008 or
an equivalent method, the total content of barium, chromium, copper, lead and tin in
the test solution shall not exceed 1 μg/mL, and the content of cadmium shall not exceed
0.1 μg/mL.
6.4 Limits for acidity and alkalinity
e) words “single-use”, or equivalent instructions, or graphic symbols conforming to
YY/T 0466.1;
f) words “sterile” and “sterilization method”, or graphic symbols conforming to
YY/T 0466.1;
g) words such as “damaged package, prohibited use” and “destroy after use”, or
graphic symbols conforming to YY/T 0466.1;
h) residual amount of liquid medicine in the fluid filter;
i) nominal pore size of the filtering medium.
8.2 Shelf or multi-unit packaging
Shelf packs or multi-unit packs (if used) shall have at least the following information:
a) manufacturer and/or distributor name and address;
b) product name, model, specifications;
c) batch number or production date, or graphic symbols conforming to YY/T 0466.1;
d) expiration date (year and month), with appropriate text attached, or graphic
symbols conforming to YY/T 0466.1;
e) words “single-use”, or equivalent instructions, or graphic symbols conforming to
YY/T 0466.1;
f) words “sterile” and “sterilization method”, or graphic symbols conforming to
YY/T 0466.1;
g) number of filters;
h) recommended storage conditions (if any).
9 Packaging
9.1 The packaging of the filter shall comply with the regulations in YY/T 0313. If
ethylene oxide is used for sterilization, the single package of the filter shall be made of
a material with air permeability on one side (such as dialysis paper).
9.2 There shall be no foreign matter that can be observed with normal vision or
corrected vision in a single package.
9.3 When the filter is used in conjunction with a single-use set local anaesthesia, it shall
be packed in double-layer sealed packaging, and it shall be indicated that it is only for
supporting.
Where:
N1 – the number of particles measured in the filtrate, in pieces per milliliter (pcs/mL);
N0 – the number of particles measured in the test solution, in pieces per milliliter
(pcs/mL).
A.2 Air filter filtration rate test
A.2.1 Test equipment
Dust particle counter: the length of the sampling tube is 1 m. The sampling frequency
is 1 time/min.
Rotor flow meter: range 60 mL/min, 80 mL/min or 100 mL/min.
A.2.2 Test steps
Under static environmental conditions, connect the dust particle counter to the flow
meter; measure the number of particles ≥ 0.5 μm in the air collected within 1 min at an
air flow rate of 50 mL/min; read 5 data continuously.
Take another air filter and connect it to the air inlet of the flowmeter according to the
direction of use. Under the same air flow rate, measure the number of particles ≥ 0.5
μm in the air flowing through the air filter within 1 minute; read 5 data continuously.
Remove the maximum and minimum values of the 5 consecutively read data, and take
the average value of the remaining 3 data.
A.2.3 Result expression
Formula (A.2) gives the filtration rate of the air filter, expressed as a percentage:
Where:
N1 – the average number of particles ≥ 0.5 μm in the air flowing through the air filter;
N0 – the average number of particles ≥ 0.5 μm in the air.
A.3 Tightness test
A.3.1 Tightness test of fluid filter
Inject distilled water from the liquid inlet end of the fluid filter; close the other end;
apply a pressure of 300 kPa; observe for 15 seconds, and there shall be no liquid leakage.
Air filter filtration rate
A.3.2 Air filter tightness test
Inject gas from the inlet end of the air filter at a pressure of 80 kPa; close the other end.
Immerse the air filter in water at 20 °C ~ 30 °C and observe for 15 s. There shall be no
gas leakage.
A.4 Particle contamination test
A.4.1 Principle
By flushing the inner cavity of the fluid filter, collect the particles in the eluate of the
fluid filter, and count them to evaluate pollution.
A.4.2 Test equipment
Particle counter: including resistance method or light resistance method, provided with
a stirring system, the sampling volume at a time is not less than 1 mL.
A.4.3 Flushing solution
Water for injection or purified water or sodium chloride injection with a mass
concentration of 9 g/L, filtered through a microporous membrane with a pore size of
0.2 μm.
A.4.4 Pretreatment
Fill the test fluid filter with the liquid in accordance with A.4.3 and soak it for 1 h at
room temperature.
A.4.5 Procedure
Take 60 mL of flushing solution; use a syringe to inject it into the pretreated liquid filter;
flow it into the sample pool of a clean counter to obtain the eluent. Count the particles
larger than or equal to 5.0 μm in the eluate in the sample pool, and the total sampling
volume shall not be less than 15 mL.
A.4.6 Result expression
Report the result by the content of particles in the eluate (pcs/mL).
......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.