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This standard is developed 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 document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the China Food and Drug Administration.
This standard is under the jurisdiction of the SAC/TC 106 National Technical Committee on Medical Syringes of Standardization Administration of China.
Introduction
During infusion, transfusion and injection, some insoluble particles enter the human body, causing harm to patients. This standard provides a general test method for particle contamination test of infusion and injection equipments.
There are three kinds of fluids for washing to choose from in this standard: purified water, isopropyl alcohol and prepared Tween-80 solution with a certain concentration. The purified water is suitable for non-silicified test samples, and isopropyl alcohol and Tween-80 solution are suitable for silicified test samples. However, the particle counter method is not applicable to Tween-80 solution as it is easy to bubble in the process of shaking or stirring. It is suggested to take necessary protection in case of using isopropyl alcohol as it is volatile and toxic. The product standards shall prevail comparing with method standards in case of selecting the test method.
Test methods for particle contamination of infusion, transfusion and injection equipments for medical use
1 Scope
This standard specifies the test methods for particle contamination of intravenous infusion, transfusion and injection equipments.
This standard is applicable to tests for particle contamination of intravenous infusion and injection equipments. Other products may refer to this standard for test methods for particle contamination.
This standard is not applicable to injection devices with a nominal capacity of 1mL or less for intramuscular injection.
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 standard, the following terms and definitions apply.
3.1
fluids for washing
fluids that have not contacted with the test samples and are used to elute the particles contained in the test samples
3.2
fluids after washing
fluids in which the particles contained in the samples have been eluted into the fluid for washing after the fluid for washing comes into contact with the test samples
3.3
blank test
test conducted for particles contained in fluids for washing, glass containers and test instruments
3.4
tubings
flexible tubes used outside the human body, whose inner surfaces are in direct or indirect contact with human blood, such as infusion and transfusion equipments
3.5
intravascular catheters
flexible tubes inserted into human blood vessels, such as central venous catheter and angiographic catheter
3.6
injection devices
apparatus at least composed of piston and barrel, such as hypodermic syringe and high-pressure angiographic syringe
3.7
containers
apparatus with large internal cavity, which is in direct or indirect contact with human blood, such as liquid storage bag/bottle and blood separation cup
Note: Containers with tubes shall be regarded as containers.
3.8
small entries
apparatus whose outer surface is in direct or indirect contact with human blood during use, such as syringe piston and guide wire
3.9
piercing devices
devices that provides infusion and injection channels for human tissue piercing, such as intravenous infusion needles and intravenous remaining needles
3.10
die lumens
devices with small inner cavity, which are in direct or indirect contact with human blood, such as heparin cap and three-way valve
3.11
unit washing fluid
fluid after washing prepared from single product with a specified method
Note: The particle contamination of single product can be independently judged based on the test result obtained from the unit washing fluid.
3.12
collected fluid
fluid after washing obtained with a specified method by gathering together the fluids after washing prepared from multiple products
Note: The collected fluid is not applicable to independent judgment on particle contamination of one product, but applicable to overall judgment on particle contamination of multiple products.
4 General
4.1 The test shall be carried out under a laminar flow cleaning condition [the clean bench meeting the requirements for ISO Class 5 (100 classes) in GB/T 25915.1-2010]. The test personnel shall wear appropriate clean clothes and gloves, and the test instruments and other required articles shall be clean and free of particles, so as to ensure that external contamination will not be introduced in the test environment and thus affecting the test results.
4.2 Prior to test, the fluid for washing shall be inspected for blank test in the same way as the fluid after washing in the corresponding test. For the purpose of the blank test, the requirement that the particle contamination of 500mL of the fluid for washing is not more than 9 shall be met. If the fluid for washing required for the test is of other volumes, its contamination index shall be converted according to the multiple relationship between the volume of the fluid for washing and 500mL.
4.3 For fluids after washing in each test, the particles shall be classified and counted according to those specified in Table 1, and the contamination index shall be calculated according to clause 12.
4.4 The particle counter used shall be calibrated at least once every year.
5 Size classification and evaluation coefficients of particles
See Table 1 for the size classification and corresponding evaluation coefficient of particles in the fluids for washing and fluids after washing.
Table 1 Size classification and evaluation coefficients of particles causing contamination
Parameter Size classification
Particle size/μm 25~50 (Category I) 51~100 (Category II) >100 (Category III)
Number of particles in the sample na1 na2 na3
Number of particles in blank test nb1 nb2 nb3
Evaluation coefficient 0.1 0.2 5
6 Principle
Select the appropriate fluids for washing to wash the test pieces with the specified method, and use the appropriate counting method to classify and count the particles in the fluids for washing (3.2).
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Size classification and evaluation coefficients of particles
6 Principle
7 Apparatus and materials
8 Selection of fluids for washing
9 Selection of counting methods
10 Preparation of fluids after washing
11 Particle counting methods
12 Expression of results
13 Test report
