YY/T 1556-2017Test methods for particle contamination of infusion, transfusion and injection equipments for medical use (English PDF)
医用输液、输血、注射器具微粒污染检验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 28, 2017
Implementation date
April 1, 2018
Scope
YY/T 1556-2017 is the English-translated version of 医用输液、输血、注射器具微粒污染检验方法.
YY/T 1556-2017 is the Chinese pharmaceutical industry standard that gives the test methods for particulate contamination of intravenous infusion, transfusion and injection equipment, the particles a set can shed into the fluid that reaches the patient.
It sets out the preparation of the test fluid and the flushing of the device, the counting of the particles by size, the environment and the blanks that keep the count honest, and the way the result is expressed. Issued on 28 March 2017, it has applied since 1 April 2018.
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Document preview — YY/T 1556-2017
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- Introduction4
- 1 Scope5
- 2 Normative references5
- 3 Terms and definitions5
- 4 General7
- 5 Particle size classification and evaluation coefficient7
- 6 Principle8
- 7 Instruments and materials8
- 8 Selection of fluids for washing9
- 9 Selection of counting method9
- 10 Preparation of fluids after washing9
- 11 Particle counting method10
- 12 Result representation11
- 13 Test report11
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
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.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
Cited by
- YY 0580-2024Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial line blood filters
- YY/T 1898-2024Intravascular catheters and guidewires - Testing method for coating adhesion
- GB/T 19335-2022Blood flow products for single use — General specification
- YY/T 1839-2022Cardiopulmonary bypass systems-Venous bubble traps
- YY/T 1760-2021Disposable drainage system for peritoneal dialysis
- YY/T 1773-2021Disposable transfer line for peritoneal dialysis
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