Valid

YY/T 0689-2008Clothing 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-X 174 bacteriophage (English PDF)

血液和体液防护装备防护服材料抗血液传播病原体穿透性能测试Phi-X174噬菌体试验方法

Preview PDF

This is a limited preview

Buy now to download the full PDF (16 pages)

Need quotation for your management?

Get a formal quotation for YY/T 0689-2008 in 30 minutes.

Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

October 17, 2008

Implementation date

January 1, 2010

Scope

YY/T 0689-2008 is the English-translated version of 血液和体液防护装备防护服材料抗血液传播病原体穿透性能测试Phi-X174噬菌体试验方法.

YY/T 0689-2008, the Chinese version of ISO 16604:2004, is a laboratory test for the resistance of protective clothing materials to penetration by blood-borne pathogens.

A surrogate virus, the Phi-X 174 bacteriophage grown on Escherichia coli, is suspended in nutrient broth adjusted to a surface tension of (0.042 ± 0.002) N/m and held against the specimen in the penetration test cell of YY/T 0699, first at 14.0 kPa and, in procedures C and D, with stepwise pressure up to 20.0 kPa.

Results are pass or fail, and live virus is detected even without visible liquid. Media, controls, specimen conditioning and the plaque assay are specified. It may not suit thick, lined or highly absorbent materials, and it is not meant as a quality control procedure. It was issued on 17 October 2008 and has applied since 1 January 2010.

Found what you need?

Document preview — YY/T 0689-2008

National Standard of the People's Republic of China

ICS: 11.100
Classification: C 40

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Microorganisms and reagents
6 Devices and materials
7 Test samples
8 Test procedure

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.

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.

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 Agar

A coagulant for culture media that supports the growth of bacteria and other microorganisms.

3.2 Assay

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 Assay fluid

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.

3.4 Bacteriophage

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 Blood-borne pathogen

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 Body fluid

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 Body fluid simulant

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 Challenge suspension

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 Lawn

A uniform collection of microorganisms grows on a thin layer of agar in a petri dish.

3.10 Lysis

The entire bacterial cell is lysed or destroyed.

3.11 Medium

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 Morphology

The shape and structure of a particular organism.

3.13 Nutrient broth

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 Penetration

The phenomenon of liquid passing through wraps, porous materials, seams, pores or other defects on the protective clothing material in a non-molecular level.

3.15 Plaque

(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 Plate

(Microbiology) Petri dish filled with culture medium.

3.18 Protective clothing

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 Surrogate microorganism

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 Titre

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 Virus

Infectious tiny organisms that have no independent metabolic system and can only replicate in living host cells.

3.22 Viral penetration

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 Viral penetration resistance

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

5.3 Pure water according to GB/T 6682-2008 level 3

5.1 Phage Ph-X174 (ATCC13706-B1) with a titer of at least 1.0 x 10^8 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.

5.2 Bacteria Escherichia coli (ATCC13706)

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.

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.

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) °C.

6.2.5 Water bath. Can obtain a temperature of (45 ± 2) °C.

6.2.6 Balance. The accuracy is 0.0001g.

6.2.9 Pressure steam sterilizer. It can maintain the temperature at (121 ± 1) °C and the absolute pressure at (214 ± 7) kPa.

6.2.10 Timer with an accuracy of at least 1s.

6.2.12 PH meter, the sensitivity is 0.1PH unit.

6.2.14 Torque wrench. has a torque of 13.6N · m.

6.2.16 Centrifuge. It has an acceleration of 10000r/min.

6.2.15 Spectrophotometer. Ability to measure absorbance at 640 nm

6.2.8 Refrigerator. Can maintain the temperature at (5 ± 3) °C

6.2.7 Vortex mixer

6.2.11 Oscillator

6.2.13 Vaccination ring

6.3 Laboratory glassware

6.3.6 Pipette. Can accurately draw 2µL

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

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.

--- 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; […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.

Referenced standards

Normative references

Cited by

Similar standards

YY/T 0700-2008|YY/T 0699-2008|YY/T 0691-2008|YY/T 1497-2016|GB/T 46937-2025|GB 38300-2025

How to Download YY/T 0689-2008

1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.