YY/T 1556-2017 (YY/T1556-2017, YYT 1556-2017, YYT1556-2017)
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Test methods for particle contamination of infusion, transfusion and injection equipments for medical use
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YY/T 1556-2017
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Standards related to: YY/T 1556-2017
| Standard ID | YY/T 1556-2017 (YY/T1556-2017) | | Description (Translated English) | Test methods for particle contamination of infusion, transfusion and injection equipments for medical use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 10,164 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Shandong Province Medical Device Product Quality Inspection Center, Shandong Xinhua Andean Medical Products Co., Ltd., Guangdong Lily Medical Technology Co., Ltd. | | Administrative Organization | National Medical Infusion Equipment Standardization Technical Committee (SAC/TC 106) | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1556-2017
YY
MEDICAL INDUSTRY STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Test methods for particle contamination of infusion,
transfusion and injection equipment for medical use
ISSUED ON: MARCH 28, 2017
IMPLEMENTED ON: APRIL 01, 2018
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 General ... 7
5 Particle size classification and evaluation coefficient ... 7
6 Principle ... 8
7 Instruments and materials ... 8
8 Selection of fluids for washing ... 9
9 Selection of counting method ... 9
10 Preparation of fluids after washing ... 9
11 Particle counting method ... 10
12 Result representation ... 11
13 Test report ... 11
Test methods for particle contamination of infusion,
transfusion and injection equipment for medical use
1 Scope
This Standard specifies test methods for particle contamination of intravenous
infusion, blood transfusion, injection equipment.
This Standard is applicable to particle contamination inspection of intravenous
infusion device. For other products, the particle contamination test method can
refer to this Standard.
This Standard is not applicable to syringe for intramuscular injection with a
nominal capacity of 1 mL or less.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB/T 6682-2008, Water for analytical laboratory use - Specification and test
methods (ISO 3696:1987, MOD)
GB/T 25915.1-2010, Cleanrooms and associated controlled environments -
Part 1: Classification of air cleanliness (ISO 14644-1:1999, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 fluids for washing
liquids that have not been contacted with test sample and are used to elute
particles contained in the test sample
3.2 fluids after washing
liquids that after the fluids for washing are in contact with the test sample, the
particles contained in the sample have been eluted into the fluid for washing
6 Principle
Choose the right fluids for washing. Rinse the test piece by the specified method.
Classify and count the particles in the fluids after washing (3.2) by a suitable
counting method.
7 Instruments and materials
7.1 Fluids for washing
7.1.1 Fluid A for washing: purified water, filtered through a membrane with a
pore size of not more than 0.22μm.
7.1.2 Fluid B for washing: isopropanol, analytically pure, filtered through a
membrane of no more than 0.22μm.
7.1.3 Fluid C for washing: Tween-80 solution, 3g of commercially available high
concentration polysorbate 80 (Tween-80) is dissolved in 10L of pure water (in
accordance with GB/T 6682-2008 level 1 or 2).
7.2 Vacuum filter
The aperture is 0.45μm.
7.3 Erlenmeyer flask
The volume is 300mL.
7.4 Ultrasonic cleaner
The frequency is 40kHz.
7.5 Oscillating device
Move at a frequency of 300 times/min ~ 350 times/min on a horizontal circular
path with a diameter of 12mm ± 1mm.
7.6 Particle counter
It uses extinction (light shading or light blocking) principle. And it can classify
and count particles in the fluids after washing according to the categories
defined in Table 1.
7.7 Microscope
Magnification is about 50 times, with proper direct illumination of 0°~10° with
the microscope stage.
after washing to obtain at least 100mL of collected fluid.
10.3.2 For syringes with a nominal capacity greater than 10mL and less than or
equal to 100mL, take 5 syringes. Respectively extract the fluids for washing of
half nominal capacity. Pull the piston to the nominal capacity. Oscillate on the
oscillating device (7.5) for 20s. Bring the fluids after washing from each syringe
together. If the fluids after washing is less than 100 mL, repeat the above steps
for the same 5 syringes. Combine the obtained fluids after washing to obtain at
least 100mL of collected fluid.
10.3.3 For test syringes with a nominal capacity greater than 100mL, take 3
syringes. Respectively extract 100mL of fluids for washing. Move the piston to
the nominal capacity. Place the cone head on the oscillating device (7.5) and
oscillate for 20s to obtain 3 portions of 100mL unit washing fluid.
10.4 Containers
Take 3 containers for supply. Respectively fill the fluids for washing of nominal
capacity through the filling tubing. Close container. Use ultrasonic cleaner to
elute 2min. Collect the fluids after washing into the sampling cup to obtain 3
portions of unit washing fluid of test sample’s nominal capacity.
10.5 Small entries
Take 10 test products. Place them in an Erlenmeyer flask (7.3). Add into 100mL
of fluids for washing. Cover the top of the conical bottle with aluminum foil (or
other suitable material). Place in an oscillating device (7.5) to oscillate for 20s
to obtain 100mL of collected fluid.
10.6 Piercing devices
Take 5 test samples. Under 1m static head, make 100mL of fluids for washing
flow through each of the 5 test samples. Collect 500mL of collected fluid in total.
10.7 Small die lumens
Take 10 test products for supply. Under 1m static-head, respectively use 50mL
of fluids for washing to flush the lumen according to the maximum flow rate so
as to obtain 500mL of collected fluid.
11 Particle counting method
11.1 Particle counter method
Use particle counter to determine the number of particles in fluids after washing.
Stir for 1min on the particle counter (7.6). The sample volume is not less than
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