ISO 22609-2004 Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed.pdf

1、 Reference number ISO 22609:2004(E) ISO 2004INTERNATIONAL STANDARD ISO 22609 First edition 2004-12-01 Clothing for protection against infectious agents Medical face masks Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) Vtements de protection c

2、ontre les agents infectieux Masques faciaux mdicaux Mthode dessai de la rsistance la pntration par un sang synthtique (volume fixe, projection horizontale) ISO 22609:2004(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be prin

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6、y any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-m

7、ail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2004 All rights reservedISO 22609:2004(E) ISO 2004 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Principle . 2 5 Apparatus and materials 3 5.1 Equi

8、pment 3 5.2 Reagents 4 6 Specimens . 4 7 Procedure 4 7.1 Preparation and cleaning of test apparatus. 4 7.2 Test procedure 5 7.3 Alternative test set-up using a targeting plate. 6 8 Report. 7 Annex A (informative) Parts list for test apparatus. 11 Annex B (normative) Preparation of synthetic blood .

9、12 Annex C (informative) Derivation of equations for stream velocity and time of delivery. 13 Bibliography . 17 ISO 22609:2004(E) iv ISO 2004 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies

10、). 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 committee has been established has the right to be represented on that committee. International organizations, governmental and no

11、n-governmental, 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, Par

12、t 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 bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting

13、 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 any or all such patent rights. ISO 22609 was prepared by Technical Committee ISO/TC 94, Personal safety Protective clothing

14、 and equipment, Subcommittee SC 13, Protective clothing. It is based on ASTM F1862-00a 4 . ISO 22609:2004(E) ISO 2004 All rights reserved vIntroduction Workers, primarily those in the health care profession, involved in treating and caring for individuals injured or sick, can be exposed to biologica

15、l 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 that cause hepatitis Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) and acquired immune de

16、ficiency syndrome (AIDS) Human Immunodeficiency Virus (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 that resists penetration. This test method was developed for ra

17、nking the synthetic blood penetration resistance performance of medical face masks in a manner representing actual use as might occur when the face mask is contacted by a high velocity stream of blood from a punctured wound. The test method is intended to evaluate the protection of the health care p

18、roviders face from exposure to blood and body fluids. It is used to evaluate the resistance of medical face masks to penetration by synthetic blood under high-velocity liquid contact with the medical face mask surface of a fixed volume over a relatively short period of time (0 s to 2,5 s). Medical f

19、ace mask “pass/fail” determinations are based on visual detection of synthetic blood penetration. NOTE 1 Medical face masks are intended to resist liquid penetration from the splatter or splashing of blood, body fluids, and other potentially infectious materials. Many factors can affect the wetting

20、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 t

21、o 0,060 N/m 1 . 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. The resulting surface tension of the synthetic blood is (0,042 0,002) N/m. NOTE 2 During a medical

22、 procedure, a blood vessel can be punctured resulting in a high-velocity stream of blood impacting a protective medical face mask. The impact velocity depends on several factors, the most important being the blood pressure of the patient. A second factor is the distance from the puncture. The veloci

23、ty of larger punctures drops because the pressure in the blood vessel drops quickly. Because only small punctures cause high-velocity streams, large punctures were not used to model the range of blood-splatter velocities considered in this test. Furthermore, this test method is based on the assumpti

24、on that the medical face mask will be in close proximity to the puncture area. This test method is therefore based on the impact velocity of a stream of fluid that corresponds to the target blood pressure. NOTE 3 The mean human blood pressure generally varies over a range of about 10,6 kPa to 16,0 k

25、Pa (80 mm Hg to 120 mm Hg) 2 . In this test method, medical face masks are tested at stream velocities corresponding to 10,6 kPa, 16,0 kPa, and 21,3 kPa (80 mm Hg, 120 mm Hg, and 160 mm Hg, respectively). This test method permits the use of other non-standard test pressures, stream velocities, fluid

26、 volumes, and specimen orientations for evaluating medical face mask penetration resistance consistent with specific applications. This International Standard does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method should review modes for face exposure an

27、d assess the appropriateness of this test method for their specific application. This International Standard primarily addresses the performance of materials or certain material constructions used in medical face masks. This test method does not address the performance of the medical face masks desi

28、gn, construction, interfaces or other factors which may affect the overall protection offered by the medical face mask and its operation (such as filtration efficiency and pressure drop). This test method does not address breathability of the medical face mask materials or any other properties affec

29、ting the ease of breathing through the medical face mask. This test method evaluates medical face masks as an item of protective clothing. This test method does not evaluate the performance of medical face masks as protection against contamination via airborne exposure pathways or in the prevention

30、of the penetration of aerosolized body fluids deposited on the medical face mask. ISO 22609:2004(E) vi ISO 2004 All rights reservedNOTE 4 Users of this test method should realize that certain tradeoffs exist between improved resistance of medical face masks to penetration by synthetic blood and in p

31、ressure drop across mask materials which is an indicator of the breathability of the face mask. In general, increasing synthetic blood penetration resistance for medical face masks results in increasing pressure drop or reduced breathability for medical face masks of the same design and fit of the i

32、ndividual wearer. NOTE 5 This test method evaluates medical face masks as an item of protective clothing and does not evaluate medical face masks as respirators. If respiratory protection for the wearer is needed, an approved respirator should be used. This test method can be used to evaluate the re

33、sistance of a respirator to penetration by synthetic blood, if warranted. INTERNATIONAL STANDARD ISO 22609:2004(E) ISO 2004 All rights reserved 1Clothing for protection against infectious agents Medical face masks Test method for resistance against penetration by synthetic blood (fixed volume, horiz

34、ontally projected) 1 Scope This International Standard describes a laboratory test method for measuring the resistance of medical face masks to penetration by a splash of synthetic blood. This International Standard primarily addresses the performance of materials or certain material constructions u

35、sed in medical face masks. This test method does not address the performance of the medical face masks design, construction, interfaces or other factors which may affect the overall protection offered by the medical face mask and its operation (such as filtration efficiency and pressure drop). This

36、test method does not evaluate the performance of medical face masks as a protection against contamination via airborne exposure pathways or in the prevention of the penetration of aerosolized body fluids deposited on the medical face mask. 2 Normative references The following referenced documents ar

37、e 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 tension by drawing up liquid f

38、ilms ISO 2859-1, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 aerosolized body fluids body fluids

39、 which have been dispersed into air as very small liquid droplets 3.2 airborne exposure pathways inhalation routes of exposure to the medical face mask wearer NOTE Inhalation routes of exposure do not include streams of blood or body fluid that may be expelled from a wound. 3.3 blood-borne pathogen

40、any infectious secreted or excreted bacterium, virus, or other disease-inducing microbe carried in blood or other body fluids ISO 22609:2004(E) 2 ISO 2004 All rights reserved3.4 body fluid any liquid produced (secreted or excreted) by the body NOTE For the purpose of this International Standard, bod

41、y fluids include those liquids potentially infected with blood- borne pathogens, including, but not limited to, blood, semen, vaginal secretions, cerebrospinal fluid, synovial fluid and peritoneal fluid, amniotic fluid, saliva in dental procedures, and any body fluid that is visibly contaminated wit

42、h blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids. 3.5 body-fluid simulant liquid which is used to act as a model for human body fluids 3.6 medical face mask item of protective clothing designed to protect portions of the wearers face

43、, including at least the mucous membrane areas of the wearers nose and mouth, from contact with blood and other body fluids during medical procedures 3.7 penetration flow of particles or liquids through closures, porous materials, seams and holes or other imperfections in a protective clothing mater

44、ial NOTE In this International Standard, the penetration liquid is synthetic blood. 3.8 protective clothing any material or combination of materials used in an item of clothing for the purpose of isolating parts of the body from contact with a potential hazard NOTE For the purpose of this Internatio

45、nal Standard, the potential hazard of contact with blood or other body fluids is simulated. 3.9 synthetic blood mixture of amaranth dye, surfactant, thickening agent, inorganic salts and distilled water having a surface tension representative of blood and some other body fluids NOTE The synthetic bl

46、ood in this test method does not simulate all of the characteristics of blood or body fluids. For example, this synthetic blood does not simulate polarity (wetting characteristics), coagulation, or content of cell matter. 4 Principle A specimen medical face mask is supported on an apparatus. A volum

47、e of synthetic blood is sprayed horizontally at the specimen mask to simulate the scenario of a mask being splashed by a punctured blood vessel. The volume of fluid, distance to impact, orifice size and fluid velocity are defined in this method and intended to be consistent with this health care sce

48、nario. Any evidence of synthetic blood penetration on the side of the medical face mask contacting the wearers face constitutes failure. Results are reported as “pass/fail”. Specimen medical face masks are evaluated at a total of three different velocities corresponding to human blood pressures of 1

49、0,6 kPa, 16,0 kPa, and 21,3 kPa. Test results are reported at each velocity and the medical face mask is rated at the highest corresponding blood pressure for which medical face mask specimens demonstrate an acceptable quality limit of 4,0. ISO 22609:2004(E) ISO 2004 All rights reserved 3NOTE This test method differs from ISO 16603 by dispensing a stream of 2 ml of synthetic blood against the target area of a complete medical mask specimen whereas ISO 16603 involves the continuous contact of a specimen of pr