YY/T 0700-2008_English: PDF (YY/T0700-2008)
| Standard ID | USD | BUY PDF | Lead-Days | Standard Title (Description) | Status |
| YY/T 0700-2008 | 254 |
Add to Cart
|
3 days
|
Clothing for protection against contact with blood and body fluids. Determination of the resistance of protective clothing materials to penetration by blood and body fluids. Test method using synthetic blood
| Valid |
| Standard ID | YY/T 0700-2008 (YY/T0700-2008) | | Description (Translated English) | Clothing for protection against contact with blood and body fluids. Determination of the resistance of protective clothing materials to penetration by blood and body fluids. Test method using synthetic blood | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.100 | | Word Count Estimation | 13,168 | | Date of Issue | 2008-10-17 | | Date of Implementation | 2010-01-01 | | Quoted Standard | GB/T 3820; GB/T 4669; GB/T 5549; YY 0660-2008 | | Adopted Standard | ISO 16603-2004, IDT | | 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 | National Food Quality and Safety Supervision and Inspection Center | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard provides for the determination of protective clothing materials to resist penetration of blood and body fluids of test methods. This test method uses YY/T 0699 required test equipment, under specified conditions in a group of continuous exposure to synthetic blood protective clothing materials. This test method is easily absorbed on a synthetic blood thicker lining inside the protective clothing materials may be invalid. |
YY/T 0700-2008
Clothing for protection against contact with blood and body fluids.Determination of the resistance of protective clothing materials to penetration by blood and body fluids.Test method using synthetic blood
ICS 11.100
C40
People's Republic of China pharmaceutical industry standards
YY/T 0700-2008/ISO 16603.2004
Blood and body fluids protective equipment
Protective clothing materials anti-penetration performance testing blood and body fluids
Synthetic blood test method
(ISO 16603.2004, IDT)
Posted 2008-10-17
2010-01-01 implementation
State Food and Drug Administration issued
Foreword
This standard is identical with ISO 16603.2004 "blood and body fluids protective equipment protective clothing materials anti-penetration performance testing blood and body fluids
Test methods for synthetic blood. "
For ease of use, this standard made the following editorial changes.
"This International Standard" be replaced by "this standard";
With a decimal point instead of a comma as the decimal point, "";
By deleting the preface to international standards.
Appendix A of this standard is an informative annex.
This standard was proposed by the State Food and Drug Administration.
This standard by the national medical clinical laboratory testing and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized.
This standard drafting unit. Beijing Medical Device Testing.
The main drafters of this standard. Liu Yi, Su Jian, Yue Weihua.
YY/T 0700-2008/ISO 16603.2004
introduction
The staff members, especially in the health care industry or wounded patient treatment and care of contact can spread easily
Diseases of biological fluids. These diseases caused by a variety of microorganisms can bring serious harm to life and health. In particular, can cause hepatitis
[Hepatitis B virus (HBV) and hepatitis C virus (HCV)] and acquired immune deficiency syndrome (AIDS) [human immunodeficiency STD
Virus (HIV)] of blood-borne diseases. Since engineering controls do not eliminate all possible contacts, people will focus on the use of protective clothing by
To minimize direct contact with skin.
This standard concerns protective clothing and designed to resist blood and body fluid penetration guards. This test method is only for the protection of the materials or make
Some materials used in the structure (such as joints) performance was evaluated. This test method does not design, the overall structure and junction parts or clothing or
Other factors affecting the overall protection protective clothing performance was evaluated.
It is worth emphasizing that this test does not have to simulations of protective clothing material contact with the liquid in actual use. Therefore, the test data should be limited to the root
According to synthetic blood penetration resistance and the material than on general assessments. Physical, chemical and thermodynamic factors may reduce material
Protective properties, before the impact of these factors tested, might lead to protective properties of the material illusion. Evaluation should consider storage
Conditions and validity of disposable (disposable) products, cleaning and sterilization of reusable product penetration resistance test for effect. Protective barriers
Integrity also be due to the use of the process of bending, friction or by the impact of pollutants such as alcohol and wet with perspiration and other factors damaged. If these
Into consideration, protective clothing material anti-synthetic blood penetration properties available to represent the desired conditions of use suitable pretreatment technique
Evaluation.
Medical protective clothing materials are intended as blood, body fluids and other potentially infectious materials barrier. A variety of factors, such as the surface of the liquid
Tension, viscosity and polarity, as well as the structure and hydrophilic or hydrophobic, can affect the wetting and penetrating properties of body fluids. Blood and body fluids (except saliva
Outer) surface tension range of about 0.042N/m ~ 0.060N/m [2]. To simulate blood and body fluids wettability of the surface tension of synthetic blood
Force adjusting to the lower limit of the range approaching that (0.042 ± 0.002) N/m.
This test method, when the protective clothing material in contact with the synthetic blood sample, to be added to the tank pressure test 14.0kPa (see step test
A and B). The results of this test under hydrostatic pressure level has been verified with a human factor related [3]. However, some studies have shown that the actual
Use can produce more than 345kPa mechanical pressure [4] [5]. Therefore, it is important to understand this test method is not simulate all the physical
Pressure applied to the pressure and use of protective clothing on. The test can also be used as a screening test can simulate YY/T 0689 for evaluation of protection
Test time and the test pressure test methods for taking anti-viral penetration in used. Test procedure C and D using progressive pressure press method
Force rose 20.0kPa. The test procedure includes the extent possible, in order to grade the performance of the material.
Since health care, activity and possible exposure to blood or body fluids diversity case, the barrier of protective clothing may be due to the requirements of the application
Change. Reasonable selection of test methods depends on the particular application of protective clothing and materials. Test methods to determine the response of wind carried
Risk assessment [1].
YY/T 0700-2008/ISO 16603.2004
Blood and body fluids protective equipment
Protective clothing materials anti-penetration performance testing blood and body fluids
Synthetic blood test method
1 Scope
This standard specifies the test method for the determination of protective clothing material to resist penetration of blood and body fluids. This test method uses
Test equipment YY/T 0699 provisions, under a set of specified conditions in a synthetic blood in continuous contact protective clothing material.
This test method has a thick lining of blood synthesized easily absorbed in the protective clothing material may be invalid.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB/T 3820 Textiles and textile products - Determination of thickness (GB/T 3820-1997, eqv ISO 5084.1996)
Determination of length and mass per unit area GB/T 4669 Textiles - Woven fabrics unit mass (GB/T 4669-2008,
ISO 3801.1997, IDT)
GB/T 5549 Determination of surfactant surface tension by drawing up liquid film method (GB/T 5549-1990, neq ISO 304. 1985)
YY 0669-2008 liquid chemicals protective equipment Protective clothing material resistance to compression test method performance liquid penetration
(ISO 13994.1998, IDT)
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
Through blood or other body fluids carry and spread of bacteria, viruses or other microorganisms.
3.2
Anti-blood and body fluids through the material.
3.3
The body produces (secretion or excretion) all the liquid.
Note. this standard, it may be infected body fluids including blood-borne pathogens by a liquid, including but not limited to blood, semen, vaginal secretions, cerebrospinal fluid, synovial fluid, and
Peritoneal fluid, amniotic fluid, saliva in dental procedures process, as well as any body fluids contaminated with visible blood and body fluids in difficult or impossible to carry out
All body fluids under the circumstances distinguish.
3.4
Humoral liquid mimic the human.
Note. This standard, synthetic blood as simulated body fluid.
YY/T 0700-2008/ISO 16603.2004
......
|