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!%SMN“2484243www
2、.din.deDIN EN ISO 21150SupersedesDIN EN ISO 21150:2009-10www.beuth.deDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.Cosmetics Microbiology Detection of Escherichia coli (ISO 21150:2015); English version EN ISO 21150:2015, English t
3、ranslation of DIN EN ISO 21150:2016-05 Kosmetische Mittel Mikrobiologie Nachweis von Escherichia coli (ISO 21150:2015); Englische Fassung EN ISO 21150:2015, Englische bersetzung von DIN EN ISO 21150:2016-05 Cosmtiques Microbiologie Dtection dEscherichia coli (ISO 21150:2015); Version anglaise EN ISO
4、 21150:2015, Traduction anglaise de DIN EN ISO 21150:2016-05 Document comprises 21 pages 04.16 DIN EN ISO 21150:2016-05 2 A comma is used as the decimal marker. National foreword This document (EN ISO 21150:2015) has been prepared by Technical Committee ISO/TC 217 “Cosmetics” (Secretariat: ISIRI, Ir
5、an) 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 Committee
6、 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 DIN EN IS
7、O 21150:2009-10 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 EN ISO 2
8、1150: 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 Enumerati
9、on 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 21150 December 2015 ICS 07.100.99; 71.100.70 Supersedes EN IS
10、O 21150:2009English Version Cosmetics Microbiology Detection of Escherichia coli (ISO 21150:2015) Cosmtiques Microbiologie Dtection dEscherichia coli (ISO 21150:2015) Kosmetische Mittel Mikrobiologie Nachweis von Escherichia coli (ISO 21150:2015) This European Standard was approved by CEN on 26 Sept
11、ember 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 concerning such national standards may be o
12、btained 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 its own language and notified to the
13、 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, Germany, Greece, Hungary, Iceland, Irel
14、and, 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 NORMUNG CEN-CENELEC Management Cent
15、re: 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 21150:2015 EEN ISO 21150:2015 (E) Contents Page European foreword . 3 Foreword 4 Introduction 5 1 Scope 6 2 Normative references 6 3 Ter
16、ms and definitions . 6 4 Principle . 7 5 Diluents and culture media . 7 5.1 General 7 5.2 Diluent for the bacterial suspension (tryptone sodium chloride solution) . 8 5.3 Culture media . 8 6 Apparatus and glassware 11 7 Strains of microorganisms 11 8 Handling of cosmetic products and laboratory samp
17、les . 11 9 Procedure 11 9.1 General recommendation . 11 9.2 Preparation of the initial suspension in the enrichment broth 11 9.3 Incubation of the inoculated enrichment broth 12 9.4 Detection and identification of Escherichia coli 12 10 Expression of the results (detection of Escherichia coli) . 13
18、11 Neutralization of the antimicrobial properties of the product . 13 11.1 General . 13 11.2 Preparation of inoculum . 13 11.3 Suitability of the detection method . 13 12 Test report 14 Annex A (informative) Other enrichment broths 15 Annex B (informative) Neutralizers of antimicrobial activity of p
19、reservatives and rinsing liquids . 18 Bibliography . 19 2 DIN EN ISO 21150:2016-05 EN ISO 21150:2015 (E) European foreword This document (EN ISO 21150:2015) has been prepared by Technical Committee ISO/TC 217 “Cosmetics” in collaboration with Technical Committee CEN/TC 392 “Cosmetics” the secretaria
20、t 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 June 2016, and conflicting national standards shall be withdrawn at the latest by June 2016. Attention is drawn to the
21、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 ISO 21150:2009. This document has been prepared under a mandate given to CEN by the
22、European Commission and the European Free Trade Association. According to the 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
23、, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, 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 tex
24、t of ISO 21150:2015 has been approved by CEN as EN ISO 21150:2015 without any modification. 3 DIN EN ISO 21150:2016-05 ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Stan
25、dards is normally carried out through ISO technical committees. 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 t
26、ake part in the work. ISO collaborates closely with the 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 p
27、articular the different approval criteria needed for the 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 o
28、f this document may be the subject of patent rights. 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
29、 www.iso.org/patents).Any trade name used in this document 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
30、 the WTO principles in the Technical Barriers to Trade (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 21150:2006), which has been technically revised
31、.4 EN ISO 21150:2015 (E) DIN EN ISO 21150:2016-05 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 paramet
32、ers such as the following: potential alteration 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 path
33、ogens such as Staphylococcus aureus, Pseudomonas 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
34、 coli) suggest hygienic failure during the manufacturing process.5 EN ISO 21150:2015 (E) DIN EN ISO 21150:2016-05 1 ScopeThis International Standard gives general guidelines for the detection and identification of the specified microorganism Escherichia coli in cosmetic products. Microorganisms cons
35、idered as specified in this International Standard 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, so as to determine the types of
36、 cosmetic products to which this International Standard 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
37、 detection of Escherichia coli in a non-selective liquid medium (enrichment broth), followed by isolation on a selective agar medium. Other methods may be appropriate, depending on the level of detection required.NOTE For the detection of Escherichia coli, subcultures can be performed on non-selecti
38、ve culture media followed by suitable identification steps (e.g. using identification kits).Because of the large variety of cosmetic products within this field of application, this method might not be suited to some products in every detail (e.g. certain water-immiscible products). Other Internation
39、al Standards (ISO 18415) may be appropriate. Other methods (e.g. automated) can be substituted for the test 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, a
40、re 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 of the referenced document (including any amendments) applies.ISO 21148:2005, Cosmetics Microbiology General instruct
41、ions for microbiological examinationEN 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
42、the purposes of this document, the following 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 suspension3.3initial suspensionsus
43、pension (or solution) of the sample in a defined volume of an appropriate enrichment broth6 EN ISO 21150:2015 (E) DIN EN ISO 21150:2016-05 3.4sample dilutiondilution of the initial suspension3.5specified microorganismaerobic mesophilic bacterium or yeast that is undesirable in a cosmetic product and
44、 is recognized as a skin pathogen species that may be harmful for human health or as an indication of hygienic failure in the manufacturing process3.6Escherichia coligram-negative rod, motile, smooth coloniesNote 1 to entry: The main characteristics for identification are catalase positive, oxidase
45、negative, fermentation of lactose, production of indole, growth on selective medium containing bile salts with characteristic colonies.Note 2 to entry: Escherichia coli can be isolated from the moist environmental sources (air, water, soil) and is a faecal contamination indicator.3.7enrichment broth
46、non-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 withou
47、t the risk of inhibition by the selective ingredients that are present in selective/differential growth media.The second step of the test (isolation) of the test is performed on a selective medium followed by identification tests.The possible inhibition of microbial growth by the sample shall be neu
48、tralized to allow the detection of viable microorganisms.1In all cases and whatever the methodology, the neutralization of the antimicrobial properties of the product shall be checked and demonstrated (see Clause 11).5 Diluents and culture media5.1 GeneralGeneral instructions are given in ISO 21148.
49、 When water is mentioned in this International Standard, use distilled water or purified water as specified in ISO 21148.The enrichment broth is used to disperse the sample and to increase the initial microbial population. It may contain neutralizers if the specimen to be tested has antimicrobial properties. The efficacy of the neutralization shall be demonstrated (see Clause 11). Information relative to suitable neutralizers is given in Annex B
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