1、May 2016 English price group 12No 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).ICS 07.100.99; 71.100.70!%SMP“2484245www
2、.din.deDIN EN ISO 22718Cosmetics Microbiology Detection of Staphylococcus aureus (ISO 22718:2015);English version EN ISO 22718:2015,English translation of DIN EN ISO 22718:2016-05Kosmetische Mittel Mikrobiologie Nachweis von Staphylococcus aureus (ISO 22718:2015);Englische Fassung EN ISO 22718:2015,
3、Englische bersetzung von DIN EN ISO 22718:2016-05Cosmtiques Microbiologie Dtection de Staphylococcus aureus (ISO 22718:2015);Version anglaise EN ISO 22718:2015,Traduction anglaise de DIN EN ISO 22718:2016-05SupersedesDIN EN ISO 22718:2009-10www.beuth.deDocument comprises 22 pagesDTranslation by DIN-
4、Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.04.16 DIN EN ISO 22718:2016-05 2 A comma is used as the decimal marker. National foreword This document (EN ISO 22718:2015) has been prepared by Technical Committee ISO/TC 217 “Cosmetics” (Secretariat: IS
5、IRI, Iran) in collaboration with Technical Committee CEN/TC 392 “Cosmetics” (Secretariat: AFNOR, France). The responsible German body involved in its preparation was DIN-Normenausschuss Lebensmittel und landwirtschaftliche Produkte (DIN Standards Committee Food and Agricultural Products), Working Co
6、mmittee NA 057-07-01 AA Kosmetische Mittel. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 18415 DIN EN ISO 18415 ISO 21148 DIN EN ISO 21148 ISO 21149 DIN EN ISO 21149 ISO 29621 DIN EN ISO 29621 Amendments This standard differs from DI
7、N EN ISO 22718:2009-10 as follows: a) normative references have been updated; b) the term “validation” (in the German version “Validierung”) has been replaced throughout the text by “suitability” (in the German version “Eignung”); c) the standard has been editorially revised. Previous editions DIN E
8、N ISO 22718: 2009-10 National Annex NA (informative) Bibliography DIN EN ISO 18415, Cosmetics Microbiology Detection of specified and non-specified microorganisms DIN EN ISO 21148, Cosmetics Microbiology General instructions for microbiological examination DIN EN ISO 21149, Cosmetics Microbiology En
9、umeration and detection of aerobic mesophilic bacteria DIN EN ISO 29621, Cosmetics Microbiology Guidelines for the risk assessment and identification of microbiologically low-risk products EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22718 December 2015 ICS 07.100.99; 71.100.70 Supersede
10、s EN ISO 22718:2009English Version Cosmetics - Microbiology - Detection of Staphylococcus aureus (ISO 22718:2015) Cosmtiques - Microbiologie - Dtection de Staphylococcus aureus (ISO 22718:2015) Kosmetische Mittel - Mikrobiologie - Nachweis von Staphylococcus aureus (ISO 22718:2015) This European Sta
11、ndard was approved by CEN on 26 September 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations 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 concern
12、ing such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. 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
13、its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Ger
14、many, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR
15、 NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 22718:2015 EEuropean foreword .3Introduction 51 Scope . 62 Normative references 63 Terms and definit
16、ions . 64 Principle 75 Diluents and culture media . 75.1 General . 75.2 Diluent for the bacterial suspension (tryptone sodium chloride solution) . 85.2.1 General 85.2.2 Composition . 85.2.3 Preparation . 85.3 Culture media . 85.3.1 General 85.3.2 Agar medium for the suitability test (see Clause 11)
17、soybean-casein digest agar medium (SCDA) or tryptic soy agar (TSA) . 85.3.3 Enrichment broth 95.3.4 Selective agar medium for isolation of Staphylococcus aureus .106 Apparatus and glassware . 117 Strains of microorganisms 118 Handling of cosmetic products and laboratory samples . 119 Procedure 129.1
18、 General recommendation . 129.2 Preparation of the initial suspension in the enrichment broth . 129.2.1 General. 129.2.2 Water-miscible products 129.2.3 Water-immiscible products . 129.2.4 Filterable products 129.3 Incubation of the inoculated enrichment broth 129.4 Detection and identification of S
19、taphylococcus aureus .129.4.1 Isolation 129.4.2 Identification of Staphylococcus aureus 1310 Expression of the results (detection of Staphylococcus aureus) 1311 Neutralization of the antimicrobial properties of the product . 1411.1 General 1411.2 Preparation of inoculum 1411.3 Suitability of the det
20、ection method 1411.3.1 Procedure 1411.3.2 Interpretation of suitability test results . 1412 Test report 15Annex A (informative) Other media .16Annex B (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids 19Bibliography .20Contents PageDIN EN ISO 22718:2016-05 EN
21、ISO 22718:2015 (E)2Foreword .4European foreword This document (EN ISO 22718:2015) has been prepared by Technical Committee ISO/TC 217 “Cosmetics“ in collaboration with Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held by AFNOR. This European Standard shall be given the stat
22、us of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2016, and conflicting national standards shall be withdrawn at the latest by June 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject o
23、f patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 22718:2009. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. According to t
24、he CEN-CENELEC 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,
25、Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 22718:2015 has been approved by CEN as EN ISO 22718:2015 without a
26、ny modification. DIN EN ISO 22718:2016-05 EN ISO 22718:2015 (E)3 ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical co
27、mmittees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with th
28、e International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for t
29、he different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.
30、ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this do
31、cument is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Tra
32、de (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 217, Cosmetics.This second edition cancels and replaces the first edition (ISO 22718:2006), of which it constitutes a minor revision.DIN EN ISO 22718:2016-05 EN ISO 22718:2015 (E
33、)4 IntroductionMicrobiological examinations of cosmetic products are carried out according to an appropriate microbiological risk analysis in order to ensure their quality and safety for consumers.Microbiological risk analysis depends on several parameters such as the following: potential alteration
34、 of cosmetic products; pathogenicity of microorganisms; site of application of the cosmetic product (hair, skin, eyes, mucous membranes); type of users (adults, children under 3 years).For cosmetics and other topical products, the detection of skin pathogens such as Staphylococcus aureus, Pseudomona
35、s aeruginosa and Candida albicans may be relevant because they can cause skin or eye infections. The detection of other kinds of microorganism might be of interest since these microorganisms (including indicators of faecal contamination e.g. Escherichia coli) suggest hygienic failure during the manu
36、facturing process.DIN EN ISO 22718:2016-05 EN ISO 22718:2015 (E)5 1 ScopeThis International Standard gives general guidelines for the detection and identification of the specified microorganism Staphylococcus aureus in cosmetic products. Microorganisms considered as specified in this International S
37、tandard might differ from country to country according to national practices or regulations.In order to ensure product quality and safety for consumers, it is advisable to perform an appropriate microbiological risk analysis to determine the types of cosmetic product to which this International Stan
38、dard is applicable. Products considered to present a low microbiological (see ISO 29621) risk include those with low water activity, hydro-alcoholic products, extreme pH values, etc.The method described in this International Standard is based on the detection of Staphylococcus aureus in a non-select
39、ive liquid medium (enrichment broth), followed by isolation on a selective agar medium. Other methods may be appropriate dependent on the level of detection required.NOTE For the detection of Staphylococcus aureus, subcultures can be performed on non-selective culture media followed by suitable iden
40、tification steps (e.g. using identification kits).Because of the large variety of cosmetic products within this field of application, this method may not be appropriate for some products in every detail (e.g. certain water immiscible products). Other International Standards (ISO 18415) may be approp
41、riate. Other methods (e.g. automated) may be substituted for the tests presented here provided that their equivalence has been demonstrated or the method has been otherwise shown to be suitable.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this doc
42、ument and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 21148:2005, Cosmetics Microbiology General instructions for microbiological examinationE
43、N 12353, Chemical disinfectants and antiseptics Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity3 Terms and definitionsFor the purposes of this document, the fo
44、llowing terms and definitions apply.3.1productportion of an identified cosmetic product received in the laboratory for testing3.2sampleportion of the product (at least 1 g or 1 ml) that is used in the test to prepare the initial suspensionDIN EN ISO 22718:2016-05 EN ISO 22718:2015 (E)6 3.3initial su
45、spensionsuspension (or solution) of the sample in a defined volume of an appropriate enrichment broth3.4sample dilutiondilution of the initial suspension3.5specified microorganismaerobic mesophilic bacterium or yeast that is undesirable in a cosmetic product and is recognized as a skin pathogen spec
46、ies that may be harmful for human health or as an indication of hygienic failure in the manufacturing process3.6Staphylococcus aureusgram-positive cocci, mainly aggregated in grape-like clusters, smooth colonies generally pigmented in yellowNote 1 to entry: The main characteristics for identificatio
47、n are: growth on specific selective medium, catalase positive, coagulase positive.Note 2 to entry: Staphylococcus aureus is an opportunistic pathogen for humans that can also be present on the skin of healthy people without causing disorder for them. It is undesirable in cosmetic products due to its
48、 potential pathogenicity.3.7enrichment brothnon-selective liquid medium containing suitable neutralizers and/or dispersing agents and demonstrated to be suitable for the product under test4 PrincipleThe first step of the procedure is to perform an enrichment by using a non-selective broth medium to increase the number of microorganisms without the risk of inhibition by the selective ingredients that are present in selective/differential growth
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