1、BRITISH STANDARD BS ISO 16604:2004 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 13.340.10 BS ISO 16604:2004 This British Standard wa
2、s published under the authority of the Standards Policy and Strategy Committee on 8 September 2004 BSI 8 September 2004 ISBN 0 580 44444 9 National foreword This British Standard reproduces verbatim ISO 16604:2004 and implements it as the UK national standard. The UK participation in its preparation
3、 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 list of organizations represented on this subcommittee can be obtained on request to its secretary. WARNING
4、 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 Committee PH/3/3 that although the test method described in this standard may be effective in the majority of
5、 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 false-negative results, or for a fabric that gives an adequate degree of protection against blood or body flu
6、ids 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 considered unequivocal. If used as the sole performance indicator in the development of new protective clothing fab
7、rics for this application this standard could also artificially restrict innovation. Cross-references The British Standards which implement international publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Ind
8、ex”, 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. Users are responsible for its correct application. Compliance with a British Standard does not of itself con
9、fer 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 change, and keep the UK interests informed; monitor related international and European developments and promulg
10、ate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the ISO title page, pages ii to vi, pages 1 to 16, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments iss
11、ued since publication Amd. No. Date Comments Reference number ISO 16604:2004(E) OSI 4002INTERNATIONAL STANDARD ISO 16604 First edition 2004-04-01 Clothing for protection against contact with blood and body fluids Determination of resistance of protective clothing materials to penetration by blood-bo
12、rne pathogens Test method using Phi-X174 bacteriophage Vtements de protection contre les contacts avec le sang et les fluides corporels Dtermination de la rsistance la pntration par des pathognes vhiculs par le sang des matriaux entrant dans la fabrication des vtements de protection Mthode dessai ut
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18、 irthgs ersedevr iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Principle . 4 5 Microorganisms and reagents. 4 6 Apparatus and materials 5 7 Test specimens . 6 7.1 Selection 6 7.2 Preparation of test specimens. 6 8 Procedure. 6 8.1 Prepa
19、ration of test media. 6 8.2 Preparation of controls. 7 8.3 Determination of material compatibility . 8 8.4 Procedure for preparation of bacteriophage suspension 8 8.5 Preparation of settle plates 9 8.6 Preliminary material measures 9 8.7 Preparation of test cell . 9 8.8 Exposure of material to bacte
20、riophage challenge suspension 10 8.9 Procedure for quantification of assay fluid 11 8.10 Interpretation of tests results 12 9 Test report 12 Annex A (informative) Sources of supplies and apparatus . 15 Bibliography . 16 BSISO16604:2004IS:40661 O4002(E) iv I SO 4002 All irthgs ersedevrForeword ISO (t
21、he International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical commit
22、tee 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. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotech
23、nical 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 International Standards. Draft International Standards adopted by the technical committees are circulated to the member
24、 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 elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying
25、 any or all such patent rights. ISO 16604 was prepared by Technical Committee ISO/TC 94, Personal safety Protective clothing and equipment, Subcommittee SC 13, Protective clothing. It is based on ASTM F1671-97b. BSISO16604:2004IS:40661 O4002(E) I SO 4002 All irthgs ersedevr vIntroduction Workers, pr
26、imarily those in the health care profession, involved in treating and caring for individuals injured or sick, can be exposed 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
27、is especially true of blood-borne viruses which cause hepatitis hepatitis B virus (HBV) and hepatitis C virus (HCV) and acquired immune deficiency syndrome (AIDS) human immunodeficiency viruses (HIV). Since engineering controls cannot eliminate all possible exposures, attention is placed on reducing
28、 the potential of direct skin contact through the use of protective clothing. This International Standard is concerned with protective clothing and related protective devices designed to protect against the penetration of blood or body fluids. Given the variety of health care settings, activities, a
29、nd the potential for exposure to blood or body fluids, the barrier requirements for protective clothing materials will change with the application. This International Standard describes a hydrostatic pressure test for measuring the viral penetration resistance of clothing materials to a surrogate vi
30、rus. The choice of an appropriate test method depends on the 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. 1This test method does not apply to all forms or conditions
31、 of blood-borne pathogen exposure. Users of this test method should review modes for worker/clothing exposure and assess the appropriateness of this test method for their specific applications. This test method has been specifically defined for modelling the viral penetration of hepatitis (B and C)
32、and human immunodeficiency viruses transmitted in blood and other potentially infectious body fluids. The surrogate microbe, Phi-X174 bacteriophage, used in this test method, is similar to HCV in size and shape but also serves as a surrogate for HBV and HIV. Inferences for protection from other path
33、ogens should be assessed on a case-by-case basis. 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, overall construction and components, or interfaces of garments or o
34、ther factors which may affect the overall protection offered by the protective clothing. It is emphasized that the test does not necessarily simulate conditions that clothing materials are likely to be exposed to in practice. The use of test data should therefore be restricted to broad comparative a
35、ssessment of such material according to their viral penetration resistance characteristics. Testing prior to degradation by physical, chemical, and thermal stresses which could negatively impact the performance of the protective barrier, could lead to a false sense of security. Consider tests which
36、assess the impact of sterilization, 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. The integrity of the protective barrier can also be compromised during us
37、e by such effects as flexing and abrasion. 1It is also possible that pre-wetting by contaminating materials such as alcohol and perspiration also compromises the integrity of the protective barrier. If these conditions are of concern, evaluate the performance of protective clothing materials for Phi
38、-X174 bacteriophage penetration 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 affect the wetti
39、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
40、 to 0,060 N/m. 2In order to help simulate the wetting characteristics of blood and body fluids, the surface tension of the Phi-X174 bacteriophage challenge suspension is adjusted to approximate the lower end of this surface tension range. The resulting surface tension of the Phi-X174 bacteriophage c
41、hallenge suspension is (0,042 0,002) N/m. BSISO16604:2004IS:40661 O4002(E) vi I SO 4002 All irthgs ersedevrPart of this method for exposing the protective clothing material specimens with Phi-X174 bacteriophage challenge suspension involves pressurization of the test cell to 14,0 kPa (in Procedures
42、A and B). This hydrostatic pressure has been documented to produce test results that correlate with visual penetration results that are obtained with a human factors validation. 3Some studies, however, suggest that mechanical pressures exceeding 345 kPa can occur during clinical use. 45Therefore, it
43、 is important to understand that this test method does not simulate all the physical stresses and pressures that are exerted on protective clothing garments during actual use. Procedures C and D use a stepped pressurization approach with pressures up to 20,0 kPa. These procedures simulate a range of
44、 possible pressures for ranking material performance. BSISO16604:2004INTENRATIONAL TSANDADR IS:40661 O4002(E)I SO 4002 All irthgs ersedevr 1Clothing for protection against contact with blood and body fluids Determination of resistance of protective clothing materials to penetration by blood-borne pa
45、thogens Test method using Phi-X174 bacteriophage 1 Scope This International Standard describes a laboratory test method for measuring the resistance of materials used in protective clothing to penetration by blood-borne pathogens. This test method uses a surrogate microbe under conditions of continu
46、ous liquid contact. Protective clothing “pass/fail” determinations are based on the detection of viral penetration at a specific hydrostatic pressure using the ISO 13994 test apparatus. This test method is not always effective in testing protective clothing materials having thick, inner liners which
47、 readily absorb the challenge fluid. This test method involves a sensitive assay procedure. Because of the length of time required to complete this test method, it might not be suitable for use as a material or protective clothing quality control or assurance procedure. 2 Normative references The fo
48、llowing referenced documents are indispensable 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 304, Surface active agents Determination of surface
49、 tension by drawing up liquid films ISO 3696:1987, Water for analytical laboratory use Specification and test methods ISO 3801, Textiles Woven fabrics Determination of mass per unit length and mass per unit area 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
