YY/T 1556-2017 PDF English
US$170.00 · In stock · Download in 9 secondsYY/T 1556-2017: Test methods for particle contamination of infusion, transfusion and injection equipment for medical use Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 1556-2017 | English | 170 |
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Test methods for particle contamination of infusion, transfusion and injection equipment for medical use
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YY/T 1556-2017: Test methods for particle contamination of infusion, transfusion and injection equipment for medical use
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1556-2017
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
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this Standard
may be the subject of patent rights. The issuing authority shall not be held
responsible for identifying any or all such patent rights.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee
on Medical Infusion Device of Standardization Administration of China (SAC/TC
106).
The drafting organizations of this Standard. Shandong Medical Device Product
Quality Inspection Center, Shandong Xinhua Ande Medical Products Co., Ltd.,
Guangdong Lily Medical Technology Co., Ltd.
Main drafters of this Standard. Yao Xiujun, Nie Jiaqi, Nie Yucai, Huang Huichan.
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
3.3 blank test
inspection for particles contained in fluids for washing, glass container as well
as test equipment
3.4 tubings
hoses that are for in vitro use, of which the inner surface is in direct or indirect
contact with human blood, such as an infusion set, a blood transfusion device,
etc.
3.5 intravascular catheters
hoses that are inserted into human blood vessel, such as central venous
catheter, contrast catheter, etc.
3.6 injection devices
devices that consist at least of piston and jacket, such as hypodermic syringe,
high-pressure contrast syringe, etc.
4 General
4.1 The test shall be carried out under laminar flow purification conditions [in
accordance with the ISO 5 level (100-level) purification workbench in GB/T
25915.1-2010].
4.2 Before the start of the test, it shall use the method that is same with
corresponding test fluids after washing to inspect fluids for washing and carry
out blank test. The blank test shall satisfy that the particle contamination index
of 500mL fluids for washing is not more than 9.
4.3 For each test, the fluids after washing shall be classified and counted
according to Table 1.Calculate the pollution index according to Chapter 12.
5 Particle size classification and evaluation coefficient
The size classification and corresponding evaluation coefficient of the particles
in fluids for washing and fluids after washing are shown in Table 1.
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.
7.2 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.
7.7 Microscope
Magnification is about 50 times, with proper direct illumination of 0°~10° with
the microscope stage.
8 Selection of fluids for washing
Purified water (7.1.1) can be selected as the fluids for washing for products that
are not siliconized. The siliconized product shall be isopropyl alcohol (7.1.2) or
9 Selection of counting method
The fluids after washing made by purified water (7.1.1) and isopropanol (7.1.2)
as fluids for washing can use particle counter method or microscopy.
10 Preparation of fluids after washing
10.1 Tubings
Take 10 test samples for supply. Under a static head of 1 m, use 500mL of fluids
for washing to respectively flush the lumen according to the maximum flow rate
to obtain 10 portions of 500mL of unit washing fluid separately.
10.3 Injection devices
10.3.1 For test syringes with a nominal capacity of less than or equal to 10mL,
take 10 syringes. Respectively extract the fluids for washing of nominal capacity.
Seal the conical joint. Immerse 5min. Place the cone vertically downward into
the ultrasonic cleaner (7.4) container to make the water in the washer immersed
above the nominal capacity but shall not submerge the syringe. Perform elution
2min.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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