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YY/T 0689-2008: Clothing for protection against contact with blood and body fluids. Determination of resistance of protective clothing materials to penetration by blood-borne pathogens. Test method using Phi-X174 bacteriophage
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Clothing for protection against contact with blood and body fluids. Determination of resistance of protective clothing materials to penetration by blood-borne pathogens. Test method using Phi-X174 bacteriophage
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YY/T 0689-2008
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Basic data | Standard ID | YY/T 0689-2008 (YY/T0689-2008) | | Description (Translated English) | Clothing for protection against contact with blood and body fluids. Determination of resistance of protective clothing materials to penetration by blood-borne pathogens. Test method using Phi-X174 bacteriophage | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.100 | | Word Count Estimation | 17,187 | | Date of Issue | 2008-10-17 | | Date of Implementation | 2010-01-01 | | Quoted Standard | GB/T 3820; GB/T 4669; GB/T 5549; GB/T 6682; YY/T 0699; YY/T 0700-2008 | | Regulation (derived from) | SFDA [2008] No. 605 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the determination of protective clothing materials, anti- blood-borne pathogen penetration of laboratory test methods. This test method uses a microorganism containing alternative suspension. Testing Protective clothing " pass/fail" is the use of the specified test YY 0699 instrument at a specific measured under hydrostatic pressure virus penetration. This test method for thick, easily absorbed by the test liquid lined protective clothing materials may be invalid. The test method in high sensitivity of certain test procedures. Since the method completion time is required, so this method is not appropriate protective clothing or protective clothing as material quality control or assurance procedures. | YY/T 0689-2008: Clothing for protection against contact with blood and body fluids. Determination of resistance of protective clothing materials to penetration by blood-borne pathogens. Test method using Phi-X174 bacteriophage
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Clothing for protection against contact with blood and body fluids.Determination of resistance of protective clothing materials to penetration by blood-borne pathogens.Test method using Phi-X174 bacteriophage
ICS 11.100
C40
People's Republic of China Pharmaceutical Industry Standard
YY/T 0689-2008/ISO 16604..2004
Protective clothing materials for blood and body fluid protection equipment
Anti-bloodborne pathogen penetration test
(ISO 16604..2004, IDT)
Released on.2008-10-17
2010-01-01 implementation
Issued by the State Food and Drug Administration
Foreword
This standard is equivalent to using ISO 16604..2004.
For ease of use, the following editorial changes have been made to this standard.
The word "this International Standard" was changed to "this Standard";
Replace the comma "," as a decimal point with a decimal point;
Delete the preface to international standards.
Appendix A of this standard is an informative appendix.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and Standardization Technical Committee for In Vitro Diagnostic Systems (SAC/TC136).
This standard was drafted by. Beijing Medical Device Inspection Institute.
The main drafters of this standard. Pan Sichun, Wang Jun, Li Jinsong, Wang Zhengqi, Yue Weihua.
YY/T 0689-2008/ISO 16604..2004
Introduction
Workers, especially those who treat and care for the wounded or sick in the health care industry, are easily accessible and can spread
Biological fluids for diseases. These diseases caused by various microorganisms can cause serious harm to life and health. Especially can cause hepatitis
[Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)] and Acquired Immunodeficiency Syndrome (AIDS) [Human Immunodeficiency Diseases
Poison (HIV)] blood-borne diseases. Because engineering controls do not eliminate all contact possibilities, people focus on the use of protective clothing
To reduce contact with the skin.
This standard focuses on protective clothing and protective equipment designed to resist penetration of blood and body fluids.
Due to the diversity of health care institutions, activities, and possible exposure to blood or body fluids, barrier requirements for protective clothing can vary depending on the application
And change.
This standard describes the hydrostatic pressure test method for the protective clothing material's resistance to the penetration of representative viruses. Reasonable test method
The choice depends on the particular application and intended use of the protective clothing and its materials. A risk assessment should be conducted to determine the test method.
This test method is not applicable to all forms or conditions of exposure to blood-borne pathogens. The tester should handle the staff/clothing
Evaluate the contact method and evaluate the rationality of the test method for its specific use. This test method has passed the hepatitis virus
(Hepatitis B and C), human immunodeficiency virus and other viruses spread in the blood and other potentially infectious body fluids to establish a penetration model
And define. The representative microorganism used in this test method-phage Ph-X174 is in size and shape with the hepatitis C virus
(HCV) is similar and can also represent hepatitis B virus (HBV) and human immunodeficiency virus (HIV). Protection against other pathogens
The impact should be evaluated on a case-by-case basis.
This test method only evaluates the performance of certain material structures (such as joints) used in materials or protection. This test method is not correct
Evaluation, overall structure and components, or clothing interface or other factors that can affect the overall protective performance of protective clothing. Worth emphasizing
Yes, this test does not need to simulate the condition of protective clothing materials in contact with liquid during actual use. Therefore, the test data should be limited to resistance to virus penetration
Ability to perform a general comparative evaluation of materials.
Physical, chemical and thermodynamic factors may reduce the protective properties of the material. Testing before these factors have an effect may lead to
The illusion of the protective properties of the material. Consideration should be given to sterilization, storage conditions and shelf life for disposable products, and cleaning and sterilization for repeatable use
Evaluation test of the impact of the penetration resistance of the used products. The integrity of the protective barrier can also be caused by bending, friction or contamination
Damaged by factors such as alcohol and sweat. If these circumstances are taken into account, the protective clothing material is resistant to the penetration of Phage-X174
The performance of can be evaluated by suitable pretreatment techniques that can represent the expected conditions of use.
Medical protective clothing materials are expected to serve as a barrier to blood, body fluids, and other potentially infectious substances. Various factors, such as the surface of the liquid
Tension, viscosity and polarity, as well as structure and hydrophilicity or hydrophobicity, can affect the wetting and penetration properties of body fluids. Blood and body fluids (except saliva
Outside) the surface tension range is about 0.042N/m ~ 0.060N/m. To help simulate the wettability of blood and body fluids, the Ph-X174
The surface tension of the phage suspension is adjusted to be close to the lower limit of this range. The surface tension of the resulting Ph-X174 phage suspension is
(0.042 ± 0.002) N/m.
This applicable method involves contacting the sample of the protective clothing material with the phage Ph-X174 suspension and the pressure of the test tank is increased to
14.0kPa (see test steps A and B). The results of this hydrostatic pressure test have been verified with the disease obtained from human factors
Poison penetration results. However, some studies have shown that clinical use can generate mechanical pressure in excess of 345 kPa. Therefore, it is important to rationalize
The solution to this test method is not to simulate all physical pressures and actual pressures applied to protective clothing. Test steps C and D use gradual pressurization
Method to increase the pressure to 20.0kPa. These test steps simulate the possible pressure range to classify the material.
YY/T 0689-2008/ISO 16604..2004
Protective clothing materials for blood and body fluid protection equipment
Anti-bloodborne pathogen penetration test
1 Scope
This standard specifies laboratory test methods for determining the ability of protective clothing materials to penetrate blood-borne pathogens. This test method uses
A suspension containing alternative microorganisms. The protective clothing test "pass/fail" is to use the test equipment specified in YY 609
The virus penetration ability was measured under hydrostatic pressure.
This test method may not be effective for protective clothing materials that are thick and lined to easily absorb test liquids.
Some test steps in this test method have higher sensitivity. Since this method requires a completion time, this method is not suitable as
Procedures for quality control or assurance of protective clothing or protective clothing materials.
2 Normative references
The clauses in the following documents become the clauses of this standard through the quotation of this standard. For dated references, all subsequent documents
The amendments (not including errata content) or revisions are not applicable to this standard, however, all parties to agreements based on this standard are encouraged to study
Is the latest version of these files available? For the cited documents without date, the latest version applies to this standard.
GB/T 3820 Determination of the thickness of textiles and textile products (GB/T 3820-1997, eqv ISO 5084..1996)
GB/T 4669 woven fabrics per unit length and unit area quality determination (GB/T 4669-2008,
ISO 3801. 1977, MOD)
GB/T 5549 Surface activity Determination of surface tension by the method of pulling up the liquid film (GB/T 5549-1990, neq ISO 304. 1985)
GB/T 6682 Specifications and test methods for analytical laboratory water (ISO 3696. 1987, MOD)
Y/T 0699 Liquid chemical protective equipment, protective clothing materials, resistance to pressurized liquid penetration test method
(YY/T 0699-2008, ISO 13994..1998, IDT)
Y/T 0700-2008 Blood and body fluid protection equipment Protective clothing material resistance to blood and body fluid penetration performance test
Method (ISO 16603..2004, IDT)
3 Terms and definitions
The following terms and definitions apply to this standard.
3.1
A coagulant for culture media that supports the growth of bacteria and other microorganisms.
3.2
Test
The mixture is analyzed to determine the presence or content of a particular component.
Note. In this test method, the analyzed component refers to the phage Ph-X174.
3.3
Sterile liquid used to rinse the surface of the test material to determine the ability of microorganisms to penetrate.
Note. In this test method, the test liquid refers to nutrient broth, and the microbial virus refers to the bacteriophage Ph-X174. Test phage Ph-X174 from the test
The inner surface of the sample is rinsed down.
YY/T 0689-2008/ISO 16604..2004
3.4
A virus that can infect bacteria.
Note. In this test method, bacteriophage refers to Ph-X174. Ph-X174 is not a pathogenic virus to humans, but can be used to simulate viruses that are pathogenic to humans.
3.5
Infectious secreted or excreted bacteria, viruses or other pathogenic microorganisms carried by blood or other body fluids.
Note. In this test method, blood-borne pathogens mainly include hepatitis viruses (hepatitis B and C), and human immunodeficiency virus (HIV). Other microorganisms should be
Case study.
3.6
Any liquid produced (secreted or excreted) by the body.
Note. In this standard, body fluids include fluids potentially infected by blood-borne pathogens, including but not limited to blood, semen, vaginal secretions, cerebrospinal fluid, synovial fluid
Fluid, ascites, amniotic fluid, saliva, and any other body fluid that is clearly contaminated with blood and all body fluids that are difficult or impossible to distinguish.
3.7
Liquid that simulates body fluids.
Note. In this test method, the body fluid simulant is bacteriophage nutrient broth, and its surface tension is close to the lower limit of the surface tension of human blood and body fluids (except saliva)
(0.042 ± 0.002) N/m.
3.8
Liquid containing reagents that can be used to test the penetration resistance of materials.
Note. In this test method, the test suspension refers to the phage test suspension, that is, the nutrient broth containing the phage Ph-X174.
3.9
A uniform collection of microorganisms grows on a thin layer of agar in a petri dish.
3.10
The entire bacterial cell is lysed or destroyed.
3.11
Nutrition system for culturing cells or tissues.
Note. In this test method, the medium refers to a complex that supports the growth of specific microorganisms, such as bacteriophage nutrient broth and upper agar.
3.12
The shape and structure of a particular organism.
3.13
Liquid medium.
Broth, for example, suspending Ph-X174 in the trough to challenge the test material, test the inner surface of the material, or dilute the test solution into a flat plate as required.
3.14
The phenomenon of liquid passing through wraps, porous materials, seams, pores or other defects on the protective clothing material in a non-molecular level
YY/T 0689-2008/ISO 16604..2004
3.15
(Virology) In theory, a clearly visible area formed by a single live virus infecting and lysing host cells.
And dissolve bacteria.
3.16
PFU
Plaque virus particles are produced by infecting and dissolving bacteria on the upper layer of agar.
3.17
(Microbiology) Petri dish filled with culture medium.
3.18
Specially designed and structured clothing, the intended use is to isolate all or part of the human body from potential hazards; or to dress the external environment
Pollution isolation.
3.19
Microorganisms used to simulate other microorganisms that are pathogenic to humans.
Note. In this test method, the representative microorganism is the bacteriophage Ph-X174, used to simulate HCV, HBV and HIV.
3.20
It acts on or corresponds to another given amount of substrate.
Note. In this test method, the titer is used to describe the concentration of surviving phages, which is expressed in PFU/mL.
3.21
Infectious tiny organisms that have no independent metabolic system and can only replicate in living host cells.
3.22
Virus penetration of a material.
Note. In this test method, virus penetration refers to the physical translocation of phage Ph-X174 through wraps, seams, pores, pinholes or other defects.
3.23
The ability of materials to prevent virus penetration under specific laboratory test conditions and test methods.
Note. In this test method, the protective clothing material with "qualified" test results is considered to have the ability to resist virus penetration.
4 Principle
Place the sample on the test device specified in YY/T 0699, add the test suspension, and perform the test at the specified time and pressure. according to
This test method can detect the live virus passing through the material even when the liquid penetration is not visible. It supplements the visual penetration test
Deficiencies. When the virus penetrates the test sample, the sample is considered unacceptable.
This test method requires basic microbiological techniques.
5 Microorganisms and reagents
5.1 Phage Ph-X174 (ATCC13706-B1) with a titer of at least 1.0 × 108 PFU/mL.
Note. The phage Ph-X174 is small, spherical (icosahedral), environmentally stable, non-infectious to humans, high sensitivity, fast growth, and titer
High, so it was selected as the most suitable blood-borne pathogen model.
YY/T 0689-2008/ISO 16604..2004
5.2 Bacteria Escherichia coli (ATCC13706).
5.3 Pure water according to GB/T 6682-2008 level 3.
5.4 Nutritional broth.
5.5 Calcium chloride (CaCl2).
5.6 Potassium chloride (KCl).
5.7 Sodium hydroxide (NaOH). 2.5mol/L.
5.8 Surfactant. Polysorbate 80.
5.9 Agar.
6 Devices and materials
6.1 Penetration test tank. See YY/T 0699 for holding the sample during contact with the pressurized test liquid.
In the test tank, the protective clothing material was used as a separator to separate the phage Ph-X174 test suspension from the visible surface of the test tank. test
The groove body of the groove is fixed on a support. The tank can hold about 60mL of phage Ph-X174 test suspension. The test tank is also equipped
A flange cover with an open area for visual observation, and a transparent cover. There is a hole in the tank for filling liquid, there is a row
The relief valve is used to discharge the liquid in the test tank. Other required components include adapters, gaskets, and supports that connect the air tube to the holes in the tank
Net etc. The schematic diagram of the test tank and its components are shown in Figure 1 and Figure 2.
1 --- transparent cover;
2 --- flange cover;
3 --- washers;
4 --- supporting net;
5 --- washers;
6- Test samples;
7 --- Upper entrance;
8 --- PTFE gasket material;
9 --- Test tank;
10 --- Drain valve;
11 --- Test slot bracket.
Figure 1 Structure of test tank
YY/T 0689-2008/ISO 16604..2004
1 --- compressed air or nitrogen;
2 --- gas pipeline joint;
3 --- gas regulating valve;
4 --- adjustable valve air release valve;
5 --- pressure gauge;
6- Valves;
7--connector;
8 --- Rubber tube with connector;
9 --- Safety shell;
10 --- test slot;
11 --- Drain valve;
12 --- Turn the clamp;
13 --- overflow prevention plate;
14 --- Double-piece collar.
Figure 2 Test device (3D view)
6.2 Other equipment
6.2.1 Thickness gauge. can measure the thickness of about 0.02mm.
6.2.2 Support net. square, mesh-like polished plastic or metal net, used to support stretchable or elastic materials, and shall meet the following characteristics.
a) Open area > 50%;
b) Deformation of test sample ≤5.0mm.
6.2.3 Air source. It can provide the air pressure from 20.0kPa to 22.0kPa.
6.2.4 Incubator. It can keep the temperature at (36 ± 1) ℃.
6.2.5 Water bath. Can obtain a temperature of (45 ± 2) ℃.
6.2.6 Balance. The accuracy is 0.0001g.
6.2.7 Vortex mixer.
YY/T 0689-2008/ISO 16604..2004
6.2.8 Refrigerator. Can maintain the temperature at (5 ± 3) ℃.
6.2.9 Pressure steam sterilizer. It can maintain the temperature at (121 ± 1) ℃ and the absolute pressure at (214 ± 7) kPa.
6.2.10 Timer with an accuracy of at least 1s.
6.2.11 Oscillator.
6.2.12 PH meter, the sensitivity is 0.1PH unit.
6.2.13 Vaccination ring.
6.2.14 Torque wrench. has a torque of 13.6N · m.
6.2.15 Spectrophotometer. Ability to measure absorbance at 640 nm.
6.2.16 Centrifuge. It has an acceleration of 10000r/min.
6.3 Laboratory glassware
6.3.1 Petri dishes. sterile.
6.3.2 Pipette. sterile, 1mL, 5mL, 10mL.
6.3.3 Test tube. 13mm × 100mm.
6.3.4 Test tube rack.
6.3.5 Glass bottle. sterile, 100mL ~ 500mL.
6.3.6 Pipette. Can accurately draw 2μL.
7 Test samples
7.1 Selection of test samples
7.1.1 Choose from a single material sample or a single protective clothing sample (if applicable, sterilized), choose a single layer or in the correct order
Stacked together can represent multiple layers of material for the actual structure of protective clothing.
If different materials are used in different parts of the protective clothing design or different thicknesses are specified, each part should be sampled.
If the design of protective clothing states that the seam can provide the same protective effect as the basic material, the sample containing the seam should be
test.
Cut each material sample into a square with a side length of at least 70 mm, with 75 mm being the best.
Randomly select 3 samples from each protective clothing material, composition, location (when non-uniform materials are designed) or other conditions
test.
If this procedure is used for the quality control of protective clothing or to provide general evidence for the anti-virus penetration performance of protective clothing materials, a large amount of data should be dealt with
Perform correct statistical design and analysis instead of using the test methods specified in this standard. For sampling plan, please refer to GB/T 28.28.1, etc.
Reference materials.
7.1.2 If the protective clothing material is sandwiched between two fiber layers with a sealing layer, the capillary effect of the material edge can cause the test results
False positives make the results unqualified. Before conducting the test, the test should be performed using adhesive, parafilm, solid paraffin or foam with adhesive
The edges of the sample are sealed to avoid the effect of "capillary action". Seal only the edges of the test sample, leaving one side longer in the center
For the 57mm square area for testing. The mounting medium must not interfere, destroy or block the sample structure in the test area. Should choose with
Mounting agent and sealing method compatible with protective clothing materials.
7.2 Preparation of test samples
Each protective clothing sample should be placed in an environment with a temperature of (21 ± 5) ° C and a relative humidity of (60 ± 10)% for at least 24 hours.
If applicable, other pretreatments such as sterilization may be applied to assess the possible damaging changes in protective clothing.
8 Test procedure
8.1 Preparation of culture medium
The phage nutrition broth recipe is as follows.
YY/T 0689-2008/ISO 16604..2004
--- Tryptone (8.0 ± 0.1) g;
--- Potassium chloride (5.0 ± 0.06) g;
--- Calcium chloride (0.2 ± 0.003) g;
--- Pure water (1000 ± 12.5) mL;
--- Surfactant (0.1 ± 0.00125) ml.
Adjust the pH to (7.3 ± 0.1) with 2.5mol/L sodium hydroxide.
Dilute 1 part of 0.1% surfactant with 9 parts of bacteriophage broth. To ensure full mixing, before sterilization, add while stirring
Hot bacteriophage nutrition broth. It is recommended that the final concentration of the surfactant is 0.01% to adjust the surface tension to (0.042 ± 0.002) N/m.
Sterilize the bacteriophage broth with a pressure steam sterilizer.
Test the surface tension of the liquid after sterilization according to GB/T 5549. If the surface tension of the bacteriophage broth is not (0.042 ±
0.002) It cannot be used within the range of N/m.
8.1.2 Lower agar
The formula of the lower agar is as follows.
--- Agar (15.0 ± 0.19) g;
--- Nutrition broth (8.0 ± 0.1) g;
--- Potassium chloride (5.0 ± 0.06) g;
--- Pure water (5.3) (1000 ± 12.5) mL;
--- Calcium chloride (1.0 ± 0.0125) mL (added after autoclaving).
Prepare 1mol/L calcium chloride solution and sterilize by pressure steam.
Adjust the pH to (7.3 ± 0.1) with 2.5mol/L sodium hydroxide.
Sterilize the bottom agar with pressure steam.
8.1.3 Upper agar
The upper agar formula is as follows.
--- Bacto-agar (7.0 ± 0.09) g;
--- Nutrition broth (8.0 ± 0.1) g;
--- Potassium chloride (5.0 ± 0.06) g;
--- Pure water (5.3) (1000 ± 12.5) mL;
--- Calcium chloride (1.0 ± 0.0125) mL (added after autoclaving).
Prepare 1mol/L calcium chloride solution and sterilize by high pressure steam.
Adjust the pH to (7.3 ± 0.1) with 2.5mol/L sodium hydroxide.
Pressure steam sterilizes the top agar.
8.2 Preparation of controls
When testing each piece of protective clothing or protective clothing material, the following controls should be used at the same time.
a) Aerosol/air pollution control. When measuring Ph-X174 phage, use a plate or other suitable method to determine the suspended or empty
The number of backgrounds carried by gas;
The following control controls should be used ...
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