1、BRITISH STANDARD BS EN ISO 22612:2005 Clothing for protection against infectious agents Test method for resistance to dry microbial penetration The European Standard EN ISO 22612:2004 has the status of a British Standard ICS 11.140; 13.340.10 BS EN ISO 22612:2005 This British Standard was published
2、under the authority of the Standards Policy and Strategy Committee on 24 March 2005 BSI 24 March 2005 ISBN 0 580 45643 9 National foreword This British Standard is the official English language version of EN ISO 22612:2005. It is identical with ISO 22612:2005. The UK participation in its preparation
3、 was entrusted by Technical Committee CH/205, Non-active medical devices, to Subcommittee CH/205/1, Medical textiles, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which im
4、plement international or European publications referred to in this document 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
5、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 confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/Euro
6、pean committee any enquiries on the interpretation, or proposals for change, 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 EN title page, pa
7、ges 2 to 15 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22612 March 2005 ICS 11.140; 13.340.10 English version Cl
8、othing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005) Vtements de protection contre les agents infectieux - Mthode dessai de la rsistance la pntration microbienne par voie sche (ISO 22612:2005) Schutzkleidung gegen infektise Agenzi
9、en - Prfverfahren zur Bestndigkeit gegen mikrobielle Penetration im trockenen Zustand (ISO 22612:2005) This European Standard was approved by CEN on 16 August 2004. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Stand
10、ard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French,
11、German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic,
12、 Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION
13、 EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 22612:2005: EEN ISO 22612:2005 (E) 2 Contents page Foreword3 Introduction .4 1 Scope 5
14、2 Normative references 5 3 Terms and definitions .5 4 Principle5 5 Testing conditions.5 6 Equipment 5 6.1 General lay-out.5 6.2 Test containers 6 6.3 Method to infect talc with spores.6 6.3.1 Materials .6 6.3.2 Procedure .7 7 Procedure .7 8 Test report 8 Annex A (informative) Preparation of TGE agar
15、 medium.11 A.1 Ingredients11 A.2 Procedure .11 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning medical devices 12 Annex ZB (informative) Relationship between this European Standard and the Essential Requirements o
16、f EU Directive 89/686/EEC concerning personal protective equipment 13 Annex ZC (normative) Normative references to international publications with their relevant European publications 14 Bibliography 15 EN ISO 22612:2005 (E) 3 Foreword This document (EN ISO 22612:2005) has been prepared by Technical
17、 Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by BSI, in collaboration with Technical Committee ISO/TC 94 “Personal safety - Protective clothing and equipment”. This European Standard shall be given the status of a national standard, either by publication of an
18、 identical text or by endorsement, at the latest by August 2005, and conflicting national standards shall be withdrawn at the latest by August 2005. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential
19、 requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annexes ZA and ZB, which are integral parts of this document. For international equivalents of cross-references to European Standards see Annex ZC. According to the CEN/CENELEC Internal Regulations, the national
20、 standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portug
21、al, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EN ISO 22612:2005 (E) 4 Introduction There are numerous examples of situations where bacteria may migrate through a barrier material in the dry state carried by organic or inorganic particles. The dry penetration of bacteria-carr
22、ying skin scales through an operating gown or a clean air suit is one example. Penetration through a packaging material during storage is another. This document EN ISO 22612 describes a test method, with the associated equipment, that may be used to determine a materials resistance to dry penetratio
23、n of bacteria on particles in the size range most typical for human skin scales EN ISO 22612:2005 (E) 5 1 Scope This test method provides a means for assessing the resistance to penetration through barrier materials of bacteria-carrying particles. NOTE Due to its complexity, this EN ISO 22612 cannot
24、 be considered as a useful method for routine quality control but may suit the needs when a material is assessed for compliance with the requirements of current regulations such as EU Directive 93/42/EEC. 2 Normative references The following referenced document is indispensable for the application o
25、f this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 13795-1:2002, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equip
26、ment Part 1: General requirements for manufacturers, processors and products. 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 13795-1:2002 apply. 4 Principle The test is carried out on test pieces each fixed in a container. In every container except o
27、ne a portion of talc contaminated with Bacillus subtilis is poured on the test piece. One container is left uncontaminated as a control. A sedimentation plate is inserted at the base of each container at a short distance below the test piece. The apparatus supporting the containers is then vibrated
28、by a pneumatic ball vibrator. The talc that penetrates is captured on the sedimentation plate. The sedimentation plates are removed and incubated. The numbers of colonies produced are counted. This document specifies two levels of challenge by means of giving two concentrations of bacterial cells on
29、 the talc particles and two times during which the barrier is subjected to vibration. The conditions for testing differ among product types and will be specified in other standards where this test method is applied such as in prEN 13795-3. 5 Testing conditions Condition the samples and test at (20 2
30、) C and (65 5) % relative humidity. 6 Equipment 6.1 General lay-out NOTE See Figure 1. EN ISO 22612:2005 (E) 6 6.1.1 A 10 mm thick stone plate, such as marble, 40 cm x 40 cm, underneath which 4 rubber stoppers are mounted at the corners. 6.1.2 A pneumatic ball vibrator 1) , able to generate 20 800 v
31、ibrations per minute with a force of 650 N. 6.1.3 The vibrator is attached by means of screws to the upper surface of the marble plate along one of its sides. 6.1.4 A compressed air flow meter capable of measuring the flow of air required to achieve a vibration frequency of 20 800 vibrations per min
32、ute. 6.1.5 Six stainless steel test containers. 6.1.6 A stainless steel plate with 6 retaining holes of suitable dimensions to fit the containers, the plate being held to the stone plate by means of clips. 6.1.7 Stopwatch. 6.2 Test containers NOTE See Figure 2. 6.2.1 A suitable stainless steel conta
33、iner with a lid. The lid has a central aperture through which a metal plunger may be inserted to reach 10 mm underneath the lid to ensure that the test material is slack when inserted. 6.2.2 Each container has a sedimentation plate insertion slot near the base. 6.2.3 To ensure good contact between t
34、he containers and the stone plate by means of the fixing plate, each container is equipped with a rubber ring resting on its flanged base. 6.2.4 The rim of the container is chamfered to prevent damage to the test piece when inserted. 6.2.5 A supply of 9 cm diameter Petri dishes containing TGE agar (
35、see Annex A). 6.3 Method to infect talc with spores 6.3.1 Materials 6.3.1.1 50 g 0,5 g of talc (95 % 15 m) 2)6.3.1.2 Purified spores of Bacillus subtilis ATCC 9372 at a concentration of 10 9/ml of ethyl alcohol 3) . 6.3.1.3 TGE agar plates. 1)e.g. K13, made by ERKALAITE OY, Helsinki, Finland. This i
36、nformation is given for the convenience of users of this document and does not constitute an endorsement by CEN of this product.2)e.g. FINNTALC M15 from OMYA BENELUX S.A., Place Eug. Keym 43 B 27, B-1170, Bruxelles, tel.: +32 26 74 23 11, fax. +32 2672 92 68. This information is given for the conven
37、ience of users of this document and does not constitute an endorsement by CEN of this product. 3)e.g. SIMICON GmbH, Schuhmacherring 12, D-81737 Mnchen, fax +49 89 67 33 66 22. This information is given for the convenience of users of this document and does not constitute an endorsement by CEN of thi
38、s product.EN ISO 22612:2005 (E) 7 6.3.2 Procedure 6.3.2.1 Prepare 50 g sterile talc in a suitable container and sterilise at 160C with dry heat for (2 0/+ 1) h. 6.3.2.2 Open an ampoule of 5 ml of the ethanolic spore solution. 6.3.2.3 Spread the spore solution in 50 steps (50 X 100 l) over the talc.
39、6.3.2.4 After every step shake the closed vessel with a vortex vibrator. 6.3.2.5 Put the opened vessel in a desiccator with silica gel and dry it at room temperature for 2 days to 3 days. 6.3.2.6 Weigh the vessel before and after drying to ensure complete drying. 6.3.2.7 Estimate the bioburden expre
40、ssed as cfu/g (3 fold, each fold two times repeated) of the spore talc mixture on TGE agar after incubation overnight at 35 C. 6.3.2.8 The final concentration should be 10 4or 10 8cfu/g talc. Ensure that the spores are homogeneously distributed in the talc. 7 Procedure 7.1 Cut 12 test pieces 200 mm
41、x 200 mm. 7.2 Put test pieces in sterilising bags and sterilize by the method given by the manufacturer. 7.3 Put containers in sterilising bags and sterilize. 7.4 Fix the bases of the containers onto the stone plate by means of the fixing plate and secure with the clips. 7.5 Aseptically remove the p
42、ieces of test material from the bags and place over the mouths of the test containers. 7.6 With the plungers distended downwards, affix the lids to the containers thus fixing the test pieces with controlled slackness. 7.7 Remove the plungers. 7.8 Pour a 0,5 g 0,1 g portion of contaminated talc throu
43、gh each plunger orifice onto 5 of the test materials leaving the 6th one uncontaminated as a control. 7.9 Seal the orifices with cling film. 7.10 Put a small plastic bag over each container. 7.11 A lidless sedimentation plate is inserted through the slot at base of each container. 7.12 Close the slo
44、ts with adhesive tape. 7.13 Run the vibrator at an air flow that achieves vibration frequency of 20 800 vibrations per minute. 7.14 Remove plastic bags and adhesive tape. 7.15 Insert the lids of the sedimentation plates through the slots. EN ISO 22612:2005 (E) 8 7.16 Remove sedimentation plates and
45、incubate at 35 C for 24 h. 7.17 Count the number of colonies produced. The control plate (6th) should read 0. If not the test should be aborted as there is extraneous contamination. 7.18 For each material repeat steps 7.1 to 7.17. 7.19 Calculate the arithmetic mean for the 10 valid results. 8 Test r
46、eport The test report shall include the following information: a) identity of material tested; b) test conditions, especially those variations chosen in 6.3.2.8 and 7.13; c) number of test pieces tested; d) any deviations from the standard method; e) details of the contaminant used; f) geometric mea
47、n of bacterial count (see 7.19). EN ISO 22612:2005 (E) 9 Dimensions in millimetres 90 45 64,5 10 400 275 124 75,5 74,5 125,5 125,5 400 1 2 3 4 5 6 7 8Key 1 Test container 2 Test material 3 Rubber stoppers 4 Pneumatic ball vibrator 5 Pneumatic hoses 6 Marble plate 7 Fixing plate 8 Clips Figure 1 Gene
48、ral layout of test equipment EN ISO 22612:2005 (E) 10 Dimensions in millimetres 111 27 1,5 22,5 20,5 95 106,5 117,5 60 1 6 3 2 7 6 4 5 60 10 8 7,0Key 1 Metal plunger 2 Base of container 3 Fixing plate 4 Sedimentation plate 5 Rubber ring 6 Test material 7 Lid 8 Sedimentation plate insertion slot Figu
49、re 2 Test container EN ISO 22612:2005 (E) 11 Annex A (informative) Preparation of TGE agar medium A.1 Ingredients Beef extract 3 g Tryptone 5 g Dextrose (glucose) 1 g Agar 15 g Distilled water 1 000 ml A.2 Procedure The solid ingredients are dissolved completely in the boiling distilled water and the pH is adjusted if necessary using dilute solutions of hydrochloric acid or sodium hydroxide so that the pH of the cooled agar at 25 C will be 7,0 0,2. It is sterilized
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