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 BS ISO 16603:2004 This British Standard was p
2、ublished 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 verbatim ISO 16603:2004 and implements it as the UK national standard. The UK participation in its preparation wa
3、s 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. A
4、ttention 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 c
5、urrent 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 fluid
6、s 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 fabri
7、cs 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 Index
8、”, 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 confe
9、r 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 promulgat
10、e 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 copyright notice displayed in this document indicates when the document was last issued. Amendments issued since p
11、ublication Amd. No. Date Comments Reference number ISO 16603:2004(E)INTERNATIONAL ADNATSDR 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 Te
12、st method using synthetic blood Vtements de protection contre les contacts avec le sang et les fluides corporels Dtermination de la rsistance des matriaux des vtements de protection la pntration par le sang et les fluides corporels Mthode dessai utilisant un sang synthtique Referecne unbmer OSI 3066
13、1:002)E(4 OSI 4002INTERNATIONAL STANDARD ISO 16603 First edition 2004-04-01 tolCnihg foorp rtitcea nogniast tnoctca wiht oolbd nadob dy lf sdiu imreteDntanoi of eht atsisernec fo cetorpitve cltohign lairetamt so enepitartb noy oolbd aob dndy iulfsd tseT temhod isus gnyntciteh olbdo etVemstn ed rpcet
14、otic noortne les ccatnost vace s elate gn sel fluised corropsle retDmniitano l eda rsistance sed tamrixua sed vemetstn ed rpcetotino la prtnatino rap s elae gnt sel fliused corropsle tMdohsed esau itisilnanu t ss gnayntthieuq BSISO16603:2004 ii BSISO16603:2004 iiiContents Page Foreword iv Introducti
15、on 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 Preparation 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 apparatu
16、s . 6 9 Test report . 6 Annex A (informative) Synthetic blood formula 9 Annex B (informative) Sources of apparatus. 10 Bibliography . 11 BSISO16603:2004iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The
17、 work of preparing International Standards is normally carried 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-gove
18、rnmental, in liaison with ISO, also take part in the work. 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. T
19、he main task of technical committees is to prepare International 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 vot
20、e. 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 any or all such patent rights. ISO 16603 was prepared by Technical Committee ISO/TC 94, Personal safety Protective clothing and e
21、quipment, Subcommittee SC 13, Protective clothing. It is based on ASTM F1670-98. BSISO16603:2004 vIntroduction Workers, primarily 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
22、. 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 acquired immune deficiency syndrome (AIDS) human immunodef
23、iciency 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 protective clothing and related protective devices des
24、igned 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, overall construction and components, or interfaces
25、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 use of test data should therefore be restricted to br
26、oad 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 protective barrier, could lead to a false sense of secu
27、rity. 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 considered. The integrity of the protective barrier can also
28、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 penetration should be evaluated following an appropri
29、ate 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 wetting and penetration characteristics of body fluids, su
30、ch 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 to 0,060 N/m. 2In order to help simulate the wetting
31、 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 specimens with synthetic blood involves pressurizati
32、on 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. 3Some studies, however, suggest that mechanical pressures exceeding 345 kPa can occur during actual use. 4 5Therefore, it is
33、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 protocol is appropriate for evaluating the viral-resistan
34、ce-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 procedures for ranking material performance. Given the va
35、riety 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 specific application of protective clothing and its
36、intended use. A risk assessment should be performed to determine the level of risk for determining the appropriate test method. 1BSISO16603:2004blankINTENRATIONAL TSANDADR IS:30661 O4002(E)1Clothing for protection against contact with blood and body fluids Determination of the resistance of protecti
37、ve clothing materials to penetration 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 c
38、ontinuous contact with the 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
39、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 3801, Textiles Woven fabrics Determination of mass per unit
40、 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 penetration by liquids under pressure 3 Terms and definitions
41、For the purposes of this document, 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 p
42、enetration 3.3 body fluid any 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 flu
43、id, synovial fluid and peritoneal 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. BSISO16603:20042 3.4 body fluid simulant liqui
44、d 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, seams and holes or other imperfections in a protective clothing material on a non-molec
45、ular 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 all or part of the body from a potential hazard; or, isolating the external environm
46、ent 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 Internati
47、onal Standard does not simulate all of the characteristics of real blood or body fluids, for example, colour, coagulation and content of cell matter. 4 Principle The resistance of a protective clothing material to penetration by blood and body fluids is determined by subjecting the material to synth
48、etic blood as a body fluid simulant for a specified time and pressure sequence and observing if visible penetration of the liquid occurs. In the penetration test apparatus, the clothing material acts as a partition separating the body fluid simulant from the viewing side of the test cell. Any eviden
49、ce of synthetic blood penetration constitutes failure. Results are reported as “pass/fail”. 5 Synthetic blood The synthetic blood shall meet the following requirements: surface tension: (0,042 0,002) N/m pH: (7,3 0,1) viscosity: (2,7 0,3) mPas conductivity: (12,0 1,2) mS/cm NOTE A suitable method of preparation can be found in Annex A. BSISO16603:2004 36 Apparatus 6.1 Penetration test cell, as specified in ISO 13
