1、October 2015 Translation by DIN-Sprachendienst.English price group 16No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).IC
2、S 11.080.20!%FmQ“2357446www.din.deDIN EN 16616Chemical disinfectants and antiseptics Chemicalthermal textile disinfection Test method and requirements (phase 2, step 2);English version EN 16616:2015,English translation of DIN EN 16616:2015-10Chemische Desinfektionsmittel und Antiseptika Chemothermis
3、che Wschedesinfektion Prfverfahren und Anforderungen (Phase 2, Stufe 2);Englische Fassung EN 16616:2015,Englische bersetzung von DIN EN 16616:2015-10Dsinfectants chimiques et antiseptiques Dsinfection thermochimique du textile Mthode dessai et prescriptions (phase 2, tape 2);Version anglaise EN 1661
4、6:2015,Traduction anglaise de DIN EN 16616:2015-10www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.DDocument comprises 38 pages 09.15DIN EN 16616:2015-10 2 A comma is used as the decimal marker. National foreword This document (EN 16616:2015) has been prep
5、ared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics” (Secretariat: AFNOR, France), Working Group WG 1 “Human medicine” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Medizin (DIN Standards Committee Medical)
6、, Working Committee NA 063-04-07 AA Chemische Desinfektionsmittel und Antiseptika in der Humanmedizin. Annex D referred to in 5.10 will give an example of a typical test report. It is intended to include Annex D in a future edition of this standard. EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM
7、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 dessai et prescriptions (phase 2
8、, tape 2) Chemische 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 Regulations which stipulate the con
9、ditions 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. This European Standard exis
10、ts 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 members are the national sta
11、ndards 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, Portugal, Romania, Slovakia, S
12、lovenia, 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 form and by any means reser
13、ved worldwide for CEN national Members. Ref. No. EN 16616:2015 EEN 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 Materials and reagents 7 5.2.1 Test organisms 7 5
14、.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 validation suspension) 14 5.4.2 Product test
15、 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 . 24 5.7 Verification of methodology 26 5.7.1 G
16、eneral . 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 . 28 5.10 Test report . 29 Annex A (informative
17、) 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 of the test method 34 Annex ZA (informative) R
18、elationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning medical devices . 35 Bibliography . 36 DIN EN 16616:2015-10 EN 16616:2015 (E) 3 European foreword This document (EN 16616:2015) has been prepared by Technical Committee CEN/TC 216 “Chemical
19、 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 national standards shall be withdrawn at
20、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 been prepared under a mandate given to
21、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-CENELEC Internal Regulations, the national
22、 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, Iceland, Ireland, Italy, Latvia, Lithuan
23、ia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 16616:2015-10 EN 16616:2015 (E)4 Introduction This European Standard specifies a carrier test for establishing whether a single-wash disinfecti
24、ng 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 practical conditions of application of the
25、 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 and types of detergents and disinfect
26、ants. 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. Instructions for use are the responsi
27、bility of manufactures of detergents or disinfectants. DIN EN 16616:2015-10 EN 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 contaminated textile. This procedur
28、e 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 carried out fully (e.g. dosing d
29、isinfectant 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 dental institutions; in schools
30、, 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 industry, laboratories, foodstuffs
31、 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 product. NOTE This method correspo
32、nds 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 references, the latest edition o
33、f 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 (including bacteriophages) activity
34、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 suspension test for the evaluation o
35、f 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 including instrument disinfectants Te
36、st 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 14885 and the following apply.
37、DIN EN 16616:2015-10 EN 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, temperature, test organisms
38、 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, step 1 test shall be pass
39、ed 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 products used 60 C EN 13624 a
40、nd 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 drum to depth of inner drum)
41、: 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 cleaning and disinfection procedu
42、re 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. The water should contain
43、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 be run one time for 30 min
44、 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, amount of water influx, revers
45、ing 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 flasks 5.3.2.21 Glass wool
46、 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 the test and the “validation
47、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 Bacteria In order to prepare t
48、he 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 second subculture from the f
49、irst 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 or Roux bottle
