YY/T 0689-2008_English: PDF (YYT0689-2008)
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| YY/T 0689-2008 | English | 334 |
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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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YY/T 0689-2008
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| 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 | 17,163 | | 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 | | Drafting Organization | Beijing Medical Device Testing | | Administrative Organization | National Standardization Technical Committee of Medical clinical testing laboratories and in vitro diagnostic systems | | Regulation (derived from) | SFDA [2008] No. 605 | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | China 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
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
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