EN 1657-2016 en Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antisep.pdf

1、BS EN 1657:2016Chemical disinfectants andantiseptics Quantitativesuspension test for theevaluation of fungicidal oryeasticidal activity of chemicaldisinfectants and antisepticsused in the veterinary area Test method and requirements(phase 2, step 1)BSI Standards PublicationBS EN 1657:2016 BRITISH ST

2、ANDARDNational forewordThis British Standard is the UK implementation of EN 1657:2016. Itsupersedes BS EN 1657:2005 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/216, Chemical disinfectants and antiseptics.A list of organizations represented on thi

3、s committee 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 2016. Published by BSI Standards Limited 2016ISBN 978 0 580 82826 3 ICS 1

4、1.080.20; 71.100.35 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2016.Amendments/Corrigenda issued since publicationDate Text affectedBS EN 1657:2016g3

5、g3g3g8g24g21g18g19g8g4g17g3g22g23g4g17g7g4g21g7g3g17g18g21g16g8g3g8g24g21g18g19g50g8g17g17g8g3g8g24g21g18g19g34g12g22g6g11g8g3g17g18g21g16g3EN 1657 g3 g3g3 g4g146g148g139g142g3g884g882g883g888g3g12g6g22g3g889g883g484g883g882g882g484g885g887g3 g22g151g146g135g148g149g135g134g135g149g3g8g17g3g883g888g

6、887g889g483g884g882g882g887g8g144g137g142g139g149g138g3g25g135g148g149g139g145g144g3g3g6g138g135g143g139g133g131g142g3g134g139g149g139g144g136g135g133g150g131g144g150g149g3g131g144g134g3g131g144g150g139g149g135g146g150g139g133g149g3g486g3g20g151g131g144g150g139g150g131g150g139g152g135g3g149g151g149g

7、146g135g144g149g139g145g144g3g150g135g149g150g3g136g145g148g3g150g138g135g3g135g152g131g142g151g131g150g139g145g144g3g145g136g3g136g151g144g137g139g133g139g134g131g142g3g145g148g3g155g135g131g149g150g139g133g139g134g131g142g3g131g133g150g139g152g139g150g155g3g145g136g3g133g138g135g143g139g133g131g14

8、2g3g134g139g149g139g144g136g135g133g150g131g144g150g149g3g131g144g134g3g131g144g150g139g149g135g146g150g139g133g149g3g151g149g135g134g3g139g144g3g150g138g135g3g152g135g150g135g148g139g144g131g148g155g3g131g148g135g131g3g486g3g23g135g149g150g3g143g135g150g138g145g134g3g131g144g134g3g148g135g147g151g1

9、39g148g135g143g135g144g150g149g3g523g146g138g131g149g135g3g884g481g3g149g150g135g146g3g883g524g3g4g144g150g139g149g135g146g150g139g147g151g135g149g3g135g150g3g134g177g149g139g144g136g135g133g150g131g144g150g149g3g133g138g139g143g139g147g151g135g149g3g486g3g8g149g149g131g139g3g147g151g131g144g150g139

10、g150g131g150g139g136g3g134g135g3g149g151g149g146g135g144g149g139g145g144g3g146g145g151g148g3g142g821g177g152g131g142g151g131g150g139g145g144g3g134g135g3g142g821g131g133g150g139g152g139g150g177g3g136g145g144g137g139g133g139g134g135g3g145g151g3g142g135g152g151g148g139g133g139g134g135g3g134g135g149g3g1

11、31g144g150g139g149g135g146g150g139g147g151g135g149g3g135g150g3g134g135g149g3g134g177g149g139g144g136g135g133g150g131g144g150g149g3g133g138g139g143g139g147g151g135g149g3g151g150g139g142g139g149g177g149g3g134g131g144g149g3g142g135g3g134g145g143g131g139g144g135g3g152g177g150g177g148g139g144g131g139g148

12、g135g3g486g3g16g177g150g138g145g134g135g3g134g821g135g149g149g131g139g3g135g150g3g146g148g135g149g133g148g139g146g150g139g145g144g149g3g523g146g138g131g149g135g3g884g481g3g177g150g131g146g135g3g883g524g3g3 g6g138g135g143g139g149g133g138g135g3g7g135g149g139g144g136g135g141g150g139g145g144g149g143g139

13、g150g150g135g142g3g151g144g134g3g4g144g150g139g149g135g146g150g139g141g131g3g486g3g20g151g131g144g150g139g150g131g150g139g152g135g148g3g22g151g149g146g135g144g149g139g145g144g149g152g135g148g149g151g133g138g3g156g151g148g3g5g135g149g150g139g143g143g151g144g137g3g134g135g148g3g136g151g144g137g139g156

14、g139g134g135g144g3g145g134g135g148g3g142g135g152g151g148g145g156g139g134g135g144g3g26g139g148g141g151g144g137g3g133g138g135g143g139g149g133g138g135g148g3g7g135g149g139g144g136g135g141g150g139g145g144g149g143g139g150g150g135g142g3g151g144g134g3g4g144g150g139g149g135g146g150g139g141g131g3g136g242g148g

15、3g134g135g144g3g25g135g150g135g148g139g144g161g148g132g135g148g135g139g133g138g3g486g3g19g148g242g136g152g135g148g136g131g138g148g135g144g3g151g144g134g3g4g144g136g145g148g134g135g148g151g144g137g135g144g3g523g19g138g131g149g135g3g884g481g3g22g150g151g136g135g3g883g524g3g23g138g139g149g3g8g151g148g1

16、45g146g135g131g144g3g22g150g131g144g134g131g148g134g3g153g131g149g3g131g146g146g148g145g152g135g134g3g132g155g3g6g8g17g3g145g144g3g884g885g3g13g131g144g151g131g148g155g3g884g882g883g888g484g3g3g3g6g8g17g3g143g135g143g132g135g148g149g3g131g148g135g3g132g145g151g144g134g3g150g145g3g133g145g143g146g142

17、g155g3g153g139g150g138g3g150g138g135g3g6g8g17g512g6g8g17g8g15g8g6g3g12g144g150g135g148g144g131g142g3g21g135g137g151g142g131g150g139g145g144g149g3g153g138g139g133g138g3g149g150g139g146g151g142g131g150g135g3g150g138g135g3g133g145g144g134g139g150g139g145g144g149g3g136g145g148g3g137g139g152g139g144g137g

18、3g150g138g139g149g3g8g151g148g145g146g135g131g144g3g22g150g131g144g134g131g148g134g3g150g138g135g3g149g150g131g150g151g149g3g145g136g3g131g3g144g131g150g139g145g144g131g142g3g149g150g131g144g134g131g148g134g3g153g139g150g138g145g151g150g3g131g144g155g3g131g142g150g135g148g131g150g139g145g144g484g3g2

19、4g146g486g150g145g486g134g131g150g135g3g142g139g149g150g149g3g131g144g134g3g132g139g132g142g139g145g137g148g131g146g138g139g133g131g142g3g148g135g136g135g148g135g144g133g135g149g3g133g145g144g133g135g148g144g139g144g137g3g149g151g133g138g3g144g131g150g139g145g144g131g142g3g149g150g131g144g134g131g14

20、8g134g149g3g143g131g155g3g132g135g3g145g132g150g131g139g144g135g134g3g145g144g3g131g146g146g142g139g133g131g150g139g145g144g3g150g145g3g150g138g135g3g6g8g17g486g6g8g17g8g15g8g6g3g16g131g144g131g137g135g143g135g144g150g3g6g135g144g150g148g135g3g145g148g3g150g145g3g131g144g155g3g6g8g17g3g143g135g143g1

21、32g135g148g484g3g3g23g138g139g149g3g8g151g148g145g146g135g131g144g3g22g150g131g144g134g131g148g134g3g135g154g139g149g150g149g3g139g144g3g150g138g148g135g135g3g145g136g136g139g133g139g131g142g3g152g135g148g149g139g145g144g149g3g523g8g144g137g142g139g149g138g481g3g9g148g135g144g133g138g481g3g10g135g14

22、8g143g131g144g524g484g3g4g3g152g135g148g149g139g145g144g3g139g144g3g131g144g155g3g145g150g138g135g148g3g142g131g144g137g151g131g137g135g3g143g131g134g135g3g132g155g3g150g148g131g144g149g142g131g150g139g145g144g3g151g144g134g135g148g3g150g138g135g3g148g135g149g146g145g144g149g139g132g139g142g139g150g

23、155g3g145g136g3g131g3g6g8g17g3g143g135g143g132g135g148g3g139g144g150g145g3g139g150g149g3g145g153g144g3g142g131g144g137g151g131g137g135g3g131g144g134g3g144g145g150g139g136g139g135g134g3g150g145g3g150g138g135g3g6g8g17g486g6g8g17g8g15g8g6g3g16g131g144g131g137g135g143g135g144g150g3g6g135g144g150g148g135

24、g3g138g131g149g3g150g138g135g3g149g131g143g135g3g149g150g131g150g151g149g3g131g149g3g150g138g135g3g145g136g136g139g133g139g131g142g3g152g135g148g149g139g145g144g149g484g3g3g6g8g17g3g143g135g143g132g135g148g149g3g131g148g135g3g150g138g135g3g144g131g150g139g145g144g131g142g3g149g150g131g144g134g131g14

25、8g134g149g3g132g145g134g139g135g149g3g145g136g3g4g151g149g150g148g139g131g481g3g5g135g142g137g139g151g143g481g3g5g151g142g137g131g148g139g131g481g3g6g148g145g131g150g139g131g481g3g6g155g146g148g151g149g481g3g6g156g135g133g138g3g21g135g146g151g132g142g139g133g481g3g7g135g144g143g131g148g141g481g3g8g1

26、49g150g145g144g139g131g481g3g9g139g144g142g131g144g134g481g3g9g145g148g143g135g148g3g28g151g137g145g149g142g131g152g3g21g135g146g151g132g142g139g133g3g145g136g3g16g131g133g135g134g145g144g139g131g481g3g9g148g131g144g133g135g481g3g10g135g148g143g131g144g155g481g3g10g148g135g135g133g135g481g3g11g151g1

27、44g137g131g148g155g481g3g12g133g135g142g131g144g134g481g3g12g148g135g142g131g144g134g481g3g12g150g131g142g155g481g3g15g131g150g152g139g131g481g3g15g139g150g138g151g131g144g139g131g481g3g15g151g154g135g143g132g145g151g148g137g481g3g16g131g142g150g131g481g3g17g135g150g138g135g148g142g131g144g134g149g4

28、81g3g17g145g148g153g131g155g481g3g19g145g142g131g144g134g481g3g19g145g148g150g151g137g131g142g481g3g21g145g143g131g144g139g131g481g3g22g142g145g152g131g141g139g131g481g3g22g142g145g152g135g144g139g131g481g3g22g146g131g139g144g481g3g22g153g135g134g135g144g481g3g22g153g139g150g156g135g148g142g131g144g

29、134g481g3g23g151g148g141g135g155g3g131g144g134g24g144g139g150g135g134g3g14g139g144g137g134g145g143g484g3g3g3g3g3g8g24g21g18g19g8g4g17g3g6g18g16g16g12g23g23g8g8g3g9g18g21g3g22g23g4g17g7g4g21g7g12g29g4g23g12g18g17g3g6g18g16g12g23g50g3g8g24g21g18g19g50g8g17g3g7g8g3g17g18g21g16g4g15g12g22g4g23g12g18g17g

30、3g8g24g21g18g19g34g12g22g6g11g8g22g3g14g18g16g12g23g8g8g3g9g111g21g3g17g18g21g16g24g17g10g3g3g3g3CEN-CENELECg3Management Centre: Avenue Marnix 17, B-1000 Brussels g825g3g884g882g883g888g3g6g8g17g3 g4g142g142g3g148g139g137g138g150g149g3g145g136g3g135g154g146g142g145g139g150g131g150g139g145g144g3g139g

31、144g3g131g144g155g3g136g145g148g143g3g131g144g134g3g132g155g3g131g144g155g3g143g135g131g144g149g3g148g135g149g135g148g152g135g134g3g153g145g148g142g134g153g139g134g135g3g136g145g148g3g6g8g17g3g144g131g150g139g145g144g131g142g3g16g135g143g132g135g148g149g484g3g21g135g136g484g3g17g145g484g3g8g17g3g883

32、g888g887g889g483g884g882g883g888g3g8BS EN 1657:2016EN 1657:2016 (E) 2 Contents European foreword . 4 Introduction 5 1 Scope 6 2 Normative references 6 3 Terms and definitions . 6 4 Requirements . 6 5 Test method 7 5.1 Principle . 7 5.2 Materials and reagents 8 5.2.1 Test organisms . 8 5.2.2 Culture

33、media and reagents 8 5.3 Apparatus and glassware 11 5.3.1 General . 11 5.3.2 Usual microbiological laboratory equipment and, in particular, the following 11 5.4 Preparation of test organism suspensions and product test solutions 12 5.4.1 Test organism suspensions (test and validation suspension) . 1

34、2 5.4.2 Product test solutions . 17 5.5 Procedure for assessing the fungicidal or yeasticidal activity of the product . 18 5.5.1 General . 18 5.5.2 Dilution-neutralization method . 19 5.5.3 Membrane filtration method . 21 5.6 Experimental data and calculation 23 5.6.1 Explanation of terms and abbrev

35、iations . 23 5.6.2 Calculation 24 5.7 Verification of methodology . 26 5.7.1 General . 26 5.7.2 Control of weighted mean counts . 27 5.7.3 Basic limits . 27 5.7.4 Additional limits for Aspergillus brasiliensis . 27 5.8 Expression of results and precision 27 5.8.1 Reduction 27 5.8.2 Control of active

36、 and non-active product test solution (5.4.2) 27 5.8.3 Limiting test organism and fungicidal/yeasticidal concentration . 28 5.8.4 Precision, replicates 28 5.9 Interpretation of results conclusion 28 5.9.1 General . 28 5.9.2 Fungicidal activity for general purposes . 28 5.9.3 Fungicidal activity for

37、specific purposes . 28 5.9.4 Yeasticidal activity for general purposes 28 5.9.5 Yeasticidal activity for specific purposes 29 5.9.6 Yeasticidal activity for teat disinfectants 29 5.10 Test report 29 Annex A (informative) Referenced strains in national collections 31 BS EN 1657:2016g8g17g3g883g888g88

38、7g889g483g884g882g883g888g3g525g8g526BS EN 1657:2016EN 1657:2016 (E) 3 Annex B (informative) Suitable neutralizers and rinsing liquids . 32 Annex C (informative) Graphical representation of test procedures 34 C.1 Dilution-neutralization method 34 C.2 Membrane filtration method 36 Annex D (informativ

39、e) Example of a typical test report . 38 Annex E (informative) Precision of the test result . 42 Bibliography . 45 BS EN 1657:2016g8g17g3g883g888g887g889g483g884g882g883g888g3g525g8g526BS EN 1657:2016EN 1657:2016 (E) 4 European foreword This document (EN 1657:2016) has been prepared by Technical Com

40、mittee 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 October 2016, and conflicting national standa

41、rds shall be withdrawn at the latest by October 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 supersedes EN 1657

42、:2005. This European Standard was revised to harmonize the preparation of the fungal spore suspension with other fungicidal tests of CEN/TC 216 and to incorporate amendments applicable to all European Standards. An additional requirement has been added for the Aspergillus spore suspension and theref

43、ore results obtained using EN 1657:2005 and not fulfilling this additional requirement will need to be confirmed by repeating the tests using EN 1657:2015. The test conditions for teat disinfectants have been added. According to the CEN/CENELEC Internal Regulations, the national standards organizati

44、ons 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, Lithuania, Luxembourg, Malta

45、, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 1657:2016g8g17g3g883g888g887g889g483g884g882g883g888g3g525g8g526BS EN 1657:2016EN 1657:2016 (E) 5 Introduction This European Standard specifies a suspension test for

46、 establishing whether a chemical disinfectant or antiseptic has a fungicidal or yeasticidal activity in the fields described in the scope. This laboratory test takes into account practical conditions of application of the product, including contact time, temperature, test organisms and interfering s

47、ubstances, i.e. conditions which may influence its action in practical situations. The conditions are intended to cover general purposes and to allow reference between laboratories and product types. Each utilization concentration of the chemical disinfectant or antiseptic found by this test corresp

48、onds to defined experimental conditions. However, for some applications the recommendations of use of a product may differ and therefore additional test conditions need to be used. BS EN 1657:2016g8g17g3g883g888g887g889g483g884g882g883g888g3g525g8g526BS EN 1657:2016EN 1657:2016 (E) 6 1 Scope This Eu

49、ropean Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or in the case of ready-to-use-products with water. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance. This European Standard applies to products that are used in the veterinary area i.e. in the breeding, husbandry, production,