1、BSI Standards PublicationBS EN 16616:2015Chemical disinfectants andantiseptics Chemical-thermaltextile disinfection Testmethod and requirements(phase 2, step 2)BS EN 16616:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 16616:2015.BSI, as a member of CEN, i
2、s obliged to publish EN 16616 as a BritishStandard. However, attention is drawn to the fact that during thedevelopment of this European Standard, the UK committee votedagainst its approval as a European Standard.The UK committee believes that this method is limited to washer-extractors. It is also c
3、onsidered that some of the reduction inmicrobial numbers achieved in the test conditions (in which avery small proportion of the load is contaminated) may be dueto redistribution of the contamination amongst the load. Hencethe antimicrobial efficacy measured by this test method may besignificantly h
4、igher, and therefore potentially misleading, thanthat obtained in practice if a greater proportion of the load iscontaminated.The UK participation in its preparation was entrusted to TechnicalCommittee CH/216, Chemical disinfectants and antiseptics.A list of organizations represented on this committ
5、ee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 82797 6ICS 11.080.20Com
6、pliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 August 2015.Amendments/corrigenda issued since publicationDate Text affectedBS EN 16616:2015EUROPEAN STANDARD NORME
7、 EUROPENNE EUROPISCHE NORM EN 16616 August 2015 ICS 11.080.20 English Version Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2) Dsinfectants chimiques et antiseptiques - Dsinfection thermochimique du textile - Mthode dessa
8、i et prescriptions (phase 2, tape 2) Chemisches Desinfektionsmittel und Antiseptika - Chemothermische Wschedesinfektion - Prfverfahren und Anforderungen (Phase 2, Stufe 2) This European Standard was approved by CEN on 3 July 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulat
9、ions which stipulate the conditions for giving this European Standard 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 CEN-CENELEC Management Centre or to any CEN member.
10、 This European Standard exists in three official versions (English, French, 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 CEN-CENELEC Management Centre has the same status as the official versions. CEN
11、members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Po
12、rtugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any
13、 form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16616:2015 EBS EN 16616:2015EN 16616:2015 (E) 2 Contents Page European foreword .3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Requirements .6 5 Test methods 7 5.1 Principle 7 5.2 Mate
14、rials and reagents 7 5.2.1 Test organisms 7 5.2.2 Culture media and reagents .8 5.3 Apparatus and glassware 10 5.3.1 General . 10 5.3.2 Usual microbiological laboratory equipment 11 5.4 Preparation of test organism suspensions and product test solutions . 14 5.4.1 Test organism suspensions (test and
15、 validation suspension) 14 5.4.2 Product test solutions for validation tests . 19 5.5 Procedure for assessing the microbicidal activity of the product 19 5.5.1 General . 19 5.5.2 Method . 21 5.6 Experimental data and calculation 24 5.6.1 Explanation of terms and abbreviations 24 5.6.2 Calculation .
16、24 5.7 Verification of methodology 26 5.7.1 General . 26 5.7.2 Control of weighted mean counts . 26 5.7.3 Basic limits 27 5.8 Expression of results and precision . 27 5.8.1 Reduction 27 5.8.2 Repetitions 28 5.9 Interpretation of results conclusion 28 5.9.1 General . 28 5.9.2 Microbicidal activity .
17、28 5.10 Test report . 29 Annex A (informative) Referenced strains in national collections 30 Annex B (informative) Suitable neutralizers and rinsing liquids . 32 B.1 General . 32 B.2 Neutralizers . 32 B.3 Neutralizer added to the agar for counting 33 Annex C (informative) Graphical representations o
18、f the test method 34 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning medical devices . 35 Bibliography . 36 BS EN 16616:2015EN 16616:2015 (E) 3 European foreword This document (EN 16616:2015) has been prepared by
19、Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2016, and conflicting n
20、ational standards shall be withdrawn at the latest by February 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document has
21、 been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN-CE
22、NELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary,
23、Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 16616:2015EN 16616:2015 (E) 4 Introduction This European Standard specifies a carrier test for establish
24、ing whether a single-wash disinfecting product or combination of products for the treatment of contaminated textile has or does not have necessary microbicidal activity. The standard only intends to validate the disinfection part of the laundry process. This laboratory test takes into account practi
25、cal conditions of application of the product including contact time, temperature, test organisms and interfering substances, i.e. conditions which may influence its action in practice. The conditions are intended to cover general purposes and to allow reference between microbiological laboratories a
26、nd types of detergents and disinfectants. Each effective dosage of the chemical disinfectant found by this test corresponds only to the chosen experimental conditions. Where actual conditions vary additional testing in microbiological laboratories shall be needed to determine the effective dosage. I
27、nstructions for use are the responsibility of manufactures of detergents or disinfectants. BS EN 16616:2015EN 16616:2015 (E) 5 1 Scope This European Standard specifies a test method and the minimum requirements for the microbicidal activity of a defined disinfection process for the treatment of cont
28、aminated textile. This procedure is carried out by using a washing machine as defined in 5.3.2.18 and refers to the disinfection step without prewash. This procedure is not limited to certain types of textile. The suppliers instructions shall be sufficient to allow the method in the standard to be c
29、arried out fully (e.g. dosing disinfectant in whatever washing phase e.g. rinsing, disinfecting at 40 C). This European Standard applies to areas and situations where disinfection is indicated. Such indications occur in patient care, for example: in hospitals, in community medical facilities and in
30、dental institutions; in schools, kindergartens and nursing homes; institutions where patients are accommodated, which could suffer from transmissible diseases; other applications where hygienic treatment of textile is necessary (e.g. food processing, hotels, workwear e.g. from the pharmaceutical ind
31、ustry, laboratories, foodstuffs area or similar institutions). The method described is intended to determine the activity of a product or product combination under the conditions in which they are used. This is a phase 2, step 2 laboratory test that simulates the conditions of application of the pro
32、duct. NOTE This method corresponds to a phase 2, step 2 test (see EN 14885). 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated r
33、eferences, the latest edition of the referenced document (including any amendments) applies. EN 12353, Chemical disinfectants and antiseptics Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (incl
34、uding bacteriophages) activity EN 13624, Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area Test method and requirements (phase 2, step 1) EN 13727, Chemical disinfectants and antiseptics Quantitative suspe
35、nsion test for the evaluation of bactericidal activity in the medical area Test method and requirements (phase 2, step 1) EN 14348, Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area includ
36、ing instrument disinfectants Test methods and requirements (phase 2, step 1) EN 14885, Chemical disinfectants and antiseptics Application of European Standards for chemical disinfectants and antiseptics 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN
37、14885 and the following apply. BS EN 16616:2015EN 16616:2015 (E) 6 3.1 liquor ratio ratio of the weight of dry textile in kilogram and volume of wash liquor in litre (w/v) 3.2 disinfection process process taking into account practical conditions of application of the product including contact time,
38、temperature, test organisms and interfering substances to disinfect the textile 3.3 treatment of contaminated textile handling the textile according the disinfection process to obtain disinfected textile 4 Requirements The test results shall fulfil the basic limits (see 5.7.3). The following phase 2
39、, step 1 test shall be passed in addition to this test: EN 13727, EN 13624 and EN 14348 under the following test conditions: temperature as recommended by the manufacturer; contact time recommended by the manufacturer; dirty conditions and reduction as recommended for instrument disinfection. For pr
40、oducts used 60 C EN 13624 and EN 14348 should be passed with Aspergillus brasiliensis and M. avium. a) Processes with temperatures 61 l; 3) Diameter of inner drum: 52 cm; 4) Depth of inner drum 31 cm); 5) Perforation: 2,5 mm to 5 mm, perforated cage surface min 600 cm2; 6) Ratio (diameter of inner d
41、rum to depth of inner drum): 1,6 + 15 %; 7) Lifting vanes (ribs): 3 having a height 10 % to 12 % of diameter of cage; base width approximately 65 mm, spacing 120; 8) Electric heating approximately KW 5,4 is recommended, thermostatically controlled; 9) Heating time to achieve 60C 30 l/min. The cleani
42、ng and disinfection procedure shall be adapted to the water hardness. Water hardness shall be logged mentioned in the laboratory protocol. The final hardness shall be equal or higher than 4 mmol/L alkaline earth ions (Mg2+and Ca2+). The temperature of the water influx should be between 12 C and 20 C
43、. The water should contain less than 100 cfu/ml of bacteria at 36 C and 22 C. It is recommended to keep the machine in an air conditioned room and control environmental conditions in temperature range of 20 C to 25 C and between 40 % to 60 % relative humidity. Before each test run the machine should
44、 be run one time for 30 min at 80C to 90C without additives. No ballast load is needed for machine preparation. It is recommended to document adequate machine parameters during the test runs to ensure a proper function of the machine and the process. This includes temperature in the wash liquor, amo
45、unt of water influx, reversing profile and if possible on/off-status of heating element. NOTE The temperature measurement with a separate calibrated data logger placed in the ballast load is preferred. 5.3.2.19 Fritted filter, porosity of 40 m to 100 m (see ISO 4793) 5.3.2.20 Roux bottles or similar
46、 flasks 5.3.2.21 Glass wool for filtration 5.4 Preparation of test organism suspensions and product test solutions 5.4.1 Test organism suspensions (test and validation suspension) 5.4.1.1 General For each test organism, two different suspensions shall be prepared: the “test suspension” to perform th
47、e test and the “validation suspension” to perform the controls and method validation. 5.4.1.2 Preservation and stock cultures of test organisms The test organisms and their stock cultures shall be prepared and kept in accordance with EN 12353. 5.4.1.3 Working culture and test organisms 5.4.1.3.1 Bac
48、teria In order to prepare the working culture of the bacteria, subculture from the stock culture by streaking onto at least approximately three plates containing TSA (5.2.2.4) E. faecium: also BHI (5.2.2.6) can be used and incubate (5.3.2.3). After 24 h incubation at (36 1) C or (37 1) C prepare a s
49、econd subculture from the first subculture in the same way and incubate. In the case of E .faecium, it is possible to prepare carriers with a shelf life of 12 weeks (storage conditions as below). In order to prepare the working culture of E. faecium for 250 test carriers, subculture from the stock culture by streaking onto at least approximately 15 plates or 10 Roux bottles containing TSA (5.2.2.4) (BHI (5.2.2.6) can be used and incubate (5.3.2.3). After 24 h incubation at (36 1) C or (37 1) C use these plates
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