EN 14347-2005 en Chemical disinfectants and antiseptics - Basic sporicidal activity - Test method and requirements (phase 1 step 1)《化学消毒剂和防腐剂 基本杀孢子活性的试验方法和要求(第1阶段 第1步骤)》.pdf

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1、BRITISH STANDARD BS EN 14347:2005 Chemical disinfectants and antiseptics Basic sporicidal activity Test method and requirements (phase 1, step 1) The European Standard EN 14347:2005 has the status of a British Standard ICS 11.080.20; 71.100.35 BS EN 14347:2005 This British Standard was published und

2、er the authority of the Standards Policy and Strategy Committee on 5 April 2005 BSI 5 April 2005 ISBN 0 580 45807 5 National foreword This British Standard is the official English language version of EN 14347:2005. The UK participation in its preparation was entrusted to Technical Committee CH/216,

3、Chemical disinfectants and antiseptics, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may b

4、e 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 does not purport to include all the necessary provisions of a contract. Users are

5、 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/European committee any enquiries on the interpretation, or proposals for change, and

6、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, pages 2 to 39 and a back cover. The BSI copyright notice displayed in this document

7、 indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN14347 March2005 ICS11.080.20;71.100.35 Englishversion ChemicaldisinfectantsandantisepticsBasicsporicidalactivity Testmethodandrequirements(phase1,s

8、tep1) DsinfectantschimiquesActivitsporicidedebase Mthodedessaietexigences ChemischeDesinfektionsmittelundAntiseptikaSporizide Wirkung(Basistest)PrfverfahrenundAnforderungen (Phase1,Stufe1) ThisEuropeanStandardwasapprovedbyCENon8December2004. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegula

9、tionswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversio

10、ns(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCentralSecretariathasthesamestatusast heofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Estonia,Finland,

11、France, Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal, Slovakia, Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeSt

12、assart,36B1050Brussels 2005CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN14347:2005:EEN 14347:2005 (E) 2 Contents Page Foreword3 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Requirements.6 5 Test method6 Annex A (informative) Re

13、ferenced strains in national collections.25 Annex B (informative) .26 Annex C (informative) Graphical representation of test procedures .28 Annex D (informative) Test report30 Annex E (informative) Information on the application and interpretation of European Standards on chemical disinfectants and

14、antiseptics .35 Annex F (normative) Precision of the Test Result .37 Bibliography 39 EN 14347:2005 (E) 3 Foreword This document (EN 14347:2005) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNOR. This European Stand

15、ard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2005, and conflicting national standards shall be withdrawn at the latest by September 2005. Attention is drawn to the possibility that some of the elements

16、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. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this Europea

17、n Standard: Austria, Belgium, Cyprus, Czech Republic, 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. EN 14347:2005 (E

18、) 4 Introduction This document describes a suspension test for establishing whether a chemical disinfectant or antiseptic has or does not have a sporicidal activity in the areas described in the scope. If a product complies with the test requirements, it can be considered as possessing a sporicidal

19、activity. The acceptibility of a product as a chemical disinfectant or antiseptic for a defined purpose cannot be determined from this test method. Chemical disinfectants or antiseptics are subjected to further testing by relevant tests according to European Standards to evaluate their activity unde

20、r conditions appropriate to their intended use. There is no evidence that the strains used in this document are virulent. EN 14347:2005 (E) 5 1 Scope This document specifies a test method (phase 1) and the minimum requirements for sporicidal activity of chemical disinfectant or antiseptic products t

21、hat form a homogeneous, physically stable preparation when diluted 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. This document applies to products that are used in agricultural (but not crop protection), d

22、omestic service, food hygiene and other industrial fields, institutional, medical and veterinary applications. NOTE 1 This method cannot be applied for testing sporicidal activity of a product against spores of Clostridium sp. NOTE 2 This document does not evaluate the activity of a product for an i

23、ntended use. More specific test methods described in European Standards (see Introduction) are used for further assessement of the efficacy of chemical disinfectants and antiseptics for a defined purpose. NOTE 3 This method corresponds to a phase 1 test (Annex E). 2 Normative references The followin

24、g referenced documents are 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. EN 12353, Chemical disinfectants and antiseptics Preservation

25、 of microbial strains used for the determination of bactericidal and fungicidal activity EN 14079, Non-active medical devices Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze 3 Terms and definitions For the purposes of this document, the fol

26、lowing terms and definitions apply. 3.1 product (for chemical disinfectants and/or antiseptics) chemical agent or formulation used as chemical disinfectant or antiseptic 3.2 sporicide product which kills dormant bacterial spores of relevant test organisms under defined conditions NOTE The adjective

27、derived from “sporicide“ is “sporicidal“ 3.3 sporicidal activity capability of a product to produce a reduction in the number of viable bacterial spores of relevant test organisms under defined conditions 3.4 sporistatic activity capability of a product to inhibit the germination of dormant bacteria

28、l spores under defined conditions EN 14347:2005 (E) 6 4 Requirements The product, when diluted with water (5.2.2.2) and tested in accordance with Clause 5 under the obligatory test conditions (20 C; 30 min, 60 min or 120 min), shall demonstrate at least a decimal log (lg) reduction in viable counts

29、of 4 and ONT (original neutralization tube) shows visible growth. It is possible to test also the product as delivered (highest test concentration is 80 %). The sporicidal activity shall be evaluated using the dormant spores of: Bacillus subtilis and Bacillus cereus. Where indicated, additional spec

30、ific sporicidal activity shall be determined applying other contact times, temperatures and test organisms in accordance with 5.2.1 and 5.5.1.1 in order to take into account intended specific use conditions. NOTE For these additional conditions, the concentration defined as a result can be lower tha

31、n the one obtained under the obligatory test conditions. 5 Test method 5.1 Principle 5.1.1 A test suspension of bacterial spores is added to a sample of the product as delivered and/or diluted with water. The mixture is maintained at 20 C 1 C for a specific contact time chosen from one of the follow

32、ing 30 min 10 s, 60 min 10 s or 120 min 60 s. At the end of this contact time, an aliquot is taken and transferred into a original neutralization tube (ONT). This tube serves for neutralizing the sporicidal and/or the sporistatic action in this portion and, after incubation, is an indicator for a su

33、ccessful neutralization in the actual test. The numbers of surviving bacterial spores in each sample are determined (by counting the sporeforming bacteria) and the reduction is calculated. 5.1.2 The test is performed using dormant spores of Bacillus subtilis and Bacillus cereus as test-organisms. 5.

34、1.3 Additional and optional contact times, temperatures and test organisms are specified. Further test organisms can be used. 5.2 Materials and reagents 5.2.1 Test organisms The sporicidal activity shall be evaluated using the dormant spores of the following organisms 1) : Bacillus subtilis subsp. s

35、pizizenii ATCC 6633 Bacillus cereus ATCC 12826 1) The ATCC numbers are the collection numbers of strains supplied by the American Type Culture Collection (ATCC). This information is given for the convenience of users of this document and does not constitute an endorsement by CEN of the product named

36、. EN 14347:2005 (E) 7 If additional test organisms are used, they shall be incubated under optimum growth conditions (temperature, time, atmosphere, media) noted in the test report. If the additional test organisms selected do not correspond to the specified strains, their suitability for supplying

37、the required inocula shall be verified. If these test organisms are not classified at a reference center, their identification characteristics shall be stated. In addition, they shall be held by the testing laboratory or national culture collection under a reference for 5 years. NOTE See Annex A for

38、 corresponding strain reference in some other culture collections. 5.2.2 Culture media and reagents 5.2.2.1 General All weights of chemical substances given in this standard refer to the anhydrous salts. Hydrated forms may be used as an alternative, but the weights required shall be adjusted to allo

39、w for consequent molecular weight differences. The reagents shall be of analytical grade and/or appropriate for microbiological purposes. They shall be free from substances that are toxic or inhibitory to the test organisms. NOTE 1 To improve reproducibility, it is recommended that commercially avai

40、lable dehydrated material is used for the preparation of culture media. The manufacturers instructions relating to the preparation of these products should be rigorously followed. NOTE 2 For each culture medium and reagent a limitation for use should be fixed. 5.2.2.2 Water The water shall be freshl

41、y glass distilled water and not demineralized water. Sterilize in the autoclave 5.3.2.1 a). NOTE 1 Sterilization is not necessary if the water is used - e.g. for preparation of culture media - and subsequently sterilized. NOTE 2 If water of adequate quality is not available, water for injections (se

42、e bibliographic reference 2) can be used. 5.2.2.3 Tryptone Soya Agar (TSA) Tryptone, pancreatic digest of casein 15,0 g Soya peptone, papaic digest of Soybean meal 5,0 g Sodium chloride (NaCl) 5,0 g Agar 15,0 g Water (5.2.2.2) to 1 000,0 ml Sterilize in the autoclave 5.3.2.1 a). After sterilization

43、the pH of the medium shall be equivalent to 7,2 0,2 when measured at 20 C. NOTE In special circumstances (problems with neutralization - see 5.5.1.2 and 5.5.1.3) it may be necessary to add neutralizer to TSA (Annex B.3). EN 14347:2005 (E) 8 5.2.2.4 Blood agar 2)Protease peptone 15,0 g Liver digest 2

44、,5 g Yeast extract 5,0 g Sodium chloride (NaCl) 5,0 g Agar 12,0 g Water (5.2.2.2) to 1 000,0 ml Defibrinated sterile sheep blood 70 ml to 100 ml Sterilize in the autoclave excluding the sheep blood 5.3.2.1 a). After sterilization cool down to 45 C to 50 C and add the sterile defibrinated sheep blood

45、 and mix thoroughly. Fill into Petri dishes. 5.2.2.5 Neutralizer The neutralizer shall be validated for the product being tested in accordance with 5.5.2.4. The neutralizer shall be sterile. NOTE 1 Information on neutralizers that have been found to be suitable for some categories of products is giv

46、en in Annex B. NOTE 2 The neutralizer has to form a homogenous, clear, not cloudy preparation when added to TSB 5.2.2.6 b). 5.2.2.6 Tryptone Soya Broth (TSB) a) Composition of Tryptone Soya Broth (TSB) Tryptone, pancreatic digest of casein 17,0 g Soya peptone, papaic digest of Soybean meal 3,0 g Sod

47、ium chloride (NaCl) 5,0 g Dipotassiumhydrogenphosphat (K 2 HPO 4 ) 2,5 g Water (5.2.2.2) to 1 000,0 ml Sterilize in the autoclave 5.3.2.1 a). After sterilization the pH of the medium shall be equivalent to 7,3 0,2 when measured at 20 C. b) Trypone Soya Broth (TSB) with neutralizer. TSB 5.2.2.6 a). A

48、n adequate neutralizer shall be added according to its chemical properties before or after autoclaving (5.2.2.5). TSB plus neutralizer should be filled into glass tubes both in portions of 9 ml and 10 ml. 2) OXOID blood agar base in an example of a suitable product available commercially. EN 14347:2005 (E) 9 5.2.2.7 Sporulation Agar (Manganese-Sulfate-Agar): Peptone USP 10,0 g Yeast extract 2,0 g Manganese sulfate (MnSO 4 ) 0,04 g Agar 15,0 g Water (5.2.2.2) to 1 000,0 ml Sterilize in autoclave 5.3.2.1 a) at 121 C + 1