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1、BRITISH STANDARD BS ISO 16603:2004 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 13.340.10 ? Licensed Copy: sheffieldun sheffieldun, na,
2、 Sun Nov 26 03:39:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 16603:2004 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 9 September 2004 BSI 9 September 2004 ISBN 0 580 44446 5 National foreword This British Standard reproduces verb
3、atim ISO 16603:2004 and implements it as the UK national standard. The UK participation in its preparation was entrusted by Technical Committee PH/3, Protective clothing, to Subcommittee PH/3/3, Protective clothing against chemicals and radioactive contamination, which has the responsibility to: A l
4、ist of organizations represented on this subcommittee can be obtained on request to its secretary. WARNING. Attention is drawn to the fact that during the development of this International Standard, the United Kingdom consistently voted against its approval as an ISO. It is the opinion of the BSI Co
5、mmittee PH/3/3 that although the test method described in this standard may be effective in the majority of current cases, it is not applicable to all types of fabric intended to protect against blood or body fluids. It is technically possible for this test method to yield both false-positive and fa
6、lse-negative results, or for a fabric that gives an adequate degree of protection against blood or body fluids to be deemed unsuitable for, and therefore un-testable by, this test method. As a tool in the selection or specification of protective clothing this test method cannot therefore be consider
7、ed unequivocal. If used as the sole performance indicator in the development of new protective clothing fabrics for this application this standard could also artificially restrict innovation. Cross-references The British Standards which implement international publications referred to in this docume
8、nt may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. U
9、sers are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for chan
10、ge, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the ISO title page, pages ii to v, a blank page, pages 1 to 11 and a back cover. The BSI copyr
11、ight notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:39:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 16603:2004(E) INTERNATIONAL AD
12、NATSDR ISO 13066 tide tsriFino -400210-40 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 Vtements de protection contre les contacts avec le s
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15、rsistance sed tamrixua sed vemetstn ed rpcetotino la prtnatino rap s elae gnt sel fliused corropsle tMdohsed esau itisilnanu t ss gnayntthieuq BS ISO 16603:2004 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:39:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii BS ISO 16603:2004 Licensed Co
16、py: sheffieldun sheffieldun, na, Sun Nov 26 03:39:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Contents Page Forewordiv Introduction v 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Principle. 2 5 Synthetic blood . 2 6 Apparatus 3 7 Test specimens . 3 7.1 Selection 3 7.2 Prep
17、aration 4 8 Procedure 4 8.1 Preliminary measures. 4 8.2 Test apparatus setup 4 8.3 Test procedure 5 8.4 Final cleanup of test apparatus. 6 9 Test report . 6 Annex A (informative) Synthetic blood formula 9 Annex B (informative) Sources of apparatus. 10 Bibliography . 11 BS ISO 16603:2004 Licensed Cop
18、y: sheffieldun sheffieldun, na, Sun Nov 26 03:39:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally ca
19、rried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work
20、. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare Intern
21、ational Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the
22、 elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 16603 was prepared by Technical Committee ISO/TC 94, Personal safety Protective clothing and equipment, Subcommittee SC 13, Protective clothing. It is
23、based on ASTM F1670-98. BS ISO 16603:2004 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:39:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v Introduction Workers, primarily those in the health care profession, involved in treating and caring for individuals injured or sick, can be exposed
24、to biological liquids capable of transmitting disease. These diseases, which may be caused by a variety of microorganisms, can pose significant risks to life and health. This is especially true of blood-borne viruses which cause hepatitis hepatitis B virus (HBV) and hepatitis C virus (HCV) and acqui
25、red immune deficiency syndrome (AIDS) human immunodeficiency viruses (HIV). Since engineering controls cannot eliminate all possible exposures, attention is placed on reducing the potential of direct skin contact through the use of protective clothing. This International Standard is concerned with p
26、rotective clothing and related protective devices designed to protect against the penetration of blood or body fluids. This test method addresses only the performance of materials or certain material constructions (e.g. seams) used in protective clothing. This test method does not address the design
27、, overall construction and components, or interfaces of garments or other factors which can affect the overall protection offered by the protective clothing. It is emphasized that the test does not necessarily simulate conditions to which clothing materials are likely to be exposed in practice. The
28、use of test data should therefore be restricted to broad comparative assessment of such material according to their synthetic blood penetration resistance characteristics. Testing prior to degradation by physical, chemical, and thermal stresses which could negatively impact the performance of the pr
29、otective barrier, could lead to a false sense of security. Tests which assess the impact of storage conditions and shelf life on the penetration resistance for disposable products, and the effects of laundering and sterilization on the penetration resistance for reusable products, should be consider
30、ed. The integrity of the protective barrier can also be compromised during use by such effects as flexing and abrasion or pre-wetting by contaminating materials such as alcohol and perspiration. If these conditions are of concern, the performance of protective clothing materials for synthetic blood
31、penetration should be evaluated following an appropriate preconditioning technique representative of the expected conditions of use. Medical protective clothing materials are intended to be a barrier to blood, body fluids, and other potentially infectious materials. Many factors can effect the wetti
32、ng and penetration characteristics of body fluids, such as surface tension, viscosity and polarity of the fluid, as well as the structure and relative hydrophilicity or, hydrophobicity of the materials. The surface tension range for blood and body fluids (excluding saliva) is approximately 0,042 N/m
33、 to 0,060 N/m.2 In order to help simulate the wetting characteristics of blood and body fluids, the surface tension of the synthetic blood is adjusted to approximate the lower end of this surface tension range, i.e. (0,042 0,002) N/m. Part of this method for exposing the protective clothing material
34、 specimens with synthetic blood involves pressurization of the test cell to 14,0 kPa (in Procedures A and B). This hydrostatic pressure has been documented to produce test results that correlate with a human factors validation.3 Some studies, however, suggest that mechanical pressures exceeding 345
35、kPa can occur during actual use.4 5 Therefore, it is important to understand that this test method does not simulate all the physical stresses and pressures that are exerted on protective clothing in use. This test method can also be used as a screening test to determine which time and pressure prot
36、ocol is appropriate for evaluating the viral-resistance-properties of protective apparel with a more sophisticated barrier test method as described in ISO 16604. Procedures C and D use a stepped pressurization approach with pressures up to 20,0 kPa. These procedures simulate a range of possible proc
37、edures for ranking material performance. Given the variety of health care settings, activities, and the potential for exposure to blood or body fluids, the barrier requirements for protective clothing materials will change with the application. The choice of an appropriate test method depends on the
38、 specific application of protective clothing and its intended use. A risk assessment should be performed to determine the level of risk for determining the appropriate test method.1 BS ISO 16603:2004 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:39:39 GMT+00:00 2006, Uncontrolled Copy, (
39、c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:39:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTENRATIONAL TSANDADR IS:30661 O4002(E) 1 Clothing for protection against contact with blood and body fluids Determination of the resistance of protective clothing materials to pe
40、netration by blood and body fluids Test method using synthetic blood 1 Scope This International Standard describes a laboratory test method for measuring the penetration resistance of clothing materials to blood and body fluids. This test method uses a synthetic blood in continuous contact with the
41、material specimen at specified set of conditions using the ISO 13994 test apparatus. This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorb the synthetic blood. 2 Normative references The following referenced documents are in
42、dispensable 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. ISO 3801, Textiles Woven fabrics Determination of mass per unit length and mass per unit a
43、rea ISO 5084, Textiles Determination of thickness of textiles and textile products ISO 13994, Clothing for protection against liquid chemicals Determination of the resistance of protective clothing materials to penetration by liquids under pressure 3 Terms and definitions For the purposes of this do
44、cument, the following terms and definitions apply. 3.1 blood-borne pathogen infectious secreted or excreted bacterium, virus, or other disease-inducing microbe carried in blood or other body fluids 3.2 blood-resistant material material that restricts blood and body fluid penetration 3.3 body fluid a
45、ny liquid produced (secreted or excreted) by the body NOTE For the purpose of this International Standard, body fluids include those liquids potentially infected with blood- borne pathogens, including, but not limited to, blood, semen, vaginal secretions, cerebrospinal fluid, synovial fluid and peri
46、toneal fluid, amniotic fluid, saliva in dental procedures, and any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids. BS ISO 16603:2004 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26
47、03:39:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 3.4 body fluid simulant liquid which is used to act as a model for human body liquids NOTE In this International Standard, synthetic blood is used as a body fluid simulant. 3.5 penetration flow of a liquid through closures, porous materials, seam
48、s and holes or other imperfections in a protective clothing material on a non-molecular level NOTE In this International Standard, the penetration liquid is synthetic blood. 3.6 protective clothing item of clothing that is specifically designed and constructed for the intended purpose of isolating a
49、ll or part of the body from a potential hazard; or, isolating the external environment from contamination by the wearer of the clothing 3.7 synthetic blood mixture of an amaranth dye, surfactant, thickening agent, inorganic salts, and distilled water having a surface tension and viscosity representative of blood and some other body fluids NOTE The synthetic blood in this International Standard does not simulate all of the characteristics of real