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!%SMO“2484244www
2、.din.deDIN EN ISO 22717Cosmetics Microbiology Detection of Pseudomonas aeruginosa (ISO 22717:2015),English version EN ISO 22717:2015,English translation of DIN EN ISO 22717:2016-05Kosmetische Mittel Mikrobiologie Nachweis von Pseudomonas aeruginosa (ISO 22717:2015);Englische Fassung EN ISO 22717:201
3、5,Englische bersetzung von DIN EN ISO 22717:2016-05Cosmtiques Microbiologie Dtection de Pseudomonas aeruginosa (ISO 22717:2015);Version anglaise EN ISO 22717:2015,Traduction anglaise de DIN EN ISO 22717:2016-05SupersedesDIN EN ISO 22717:2009-10www.beuth.deDocument comprises 20 pagesDTranslation by D
4、IN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.04.16 DIN EN ISO 22717:2016-05 2 A comma is used as the decimal marker. National foreword This document (EN ISO 22717:2015) has been prepared by Technical Committee ISO/TC 217 “Cosmetics” (Secretariat:
5、 ISIRI, 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
6、 Committee 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
7、 DIN EN ISO 22717:2009-10 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 DI
8、N EN ISO 22717: 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
9、 Enumeration 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 22717 December 2015 ICS 07.100.99; 71.100.70 Supers
10、edes EN ISO 22717:2009English Version Cosmetics - Microbiology - Detection of Pseudomonas aeruginosa (ISO 22717:2015) Cosmtiques - Microbiologie - Dtection de Pseudomonas aeruginosa (ISO 22717:2015) Kosmetische Mittel - Mikrobiologie - Nachweis von Pseudomonas aeruginosa (ISO 22717:2015) This Europe
11、an Standard 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 c
12、oncerning 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
13、 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 standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Franc
14、e, Germany, 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 KOMI
15、TEE 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 reserved worldwide for CEN national Members. Ref. No. EN ISO 22717:2015 EEuropean foreword .3Introduction 51 Scope . 62 Normative references 63 Terms and d
16、efinitions . 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 Claus
17、e 11) soybeancasein digest agar medium (SCDA) or tryptic soy agar (TSA) . 85.3.3 Enrichment broth 95.3.4 Selective agar medium for isolation of Pseudomonas aeruginosa 105.3.5 Selective agar medium for confirmation of Pseudomonas aeruginosa . 1106 Apparatus and glassware . 117 Strains of microorganis
18、ms 118 Handling of cosmetic products and laboratory samples . 119 Procedure 119.1 General recommendation . 119.2 Preparation of the initial suspension in the enrichment broth . 119.2.1 General. 119.2.2 Water-miscible products 129.2.3 Water-immiscible products . 129.2.4 Filterable products 129.3 Incu
19、bation of the inoculated enrichment broth 129.4 Detection and Identification of Pseudomonas aeruginosa 1129.4.1 Isolation 129.4.2 Identification of Pseudomonas aeruginosa .12210 Expression of results (detection of Pseudomonas aeruginosa) 1311 Neutralization of the antimicrobial properties of the pro
20、duct . 1311.1 General 1311.2 Preparation of the inoculum 1311.3 Suitability of the detection method 1311.3.1 Procedure 1311.3.2 Interpretation of suitability test results . 1412 Test report 14Annex A (informative) Other enrichment broths .15Annex B (informative) Neutralizers of antimicrobial activit
21、y of preservatives and rinsing liquids 17Bibliography .18Contents PageDIN EN ISO 22717:2016-05EN ISO 22717:2015 (E)2Foreword .4European foreword This document (EN ISO 22717:2015) has been prepared by Technical Committee ISO/TC 217 “Cosmetics“ in collaboration with Technical Committee CEN/TC 392 “Cos
22、metics” 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 June 2016, and conflicting national standards shall be withdrawn at the latest by June 2016. Atte
23、ntion 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 CEN by the European Commission an
24、d the European Free Trade Association. This document supersedes EN ISO 22717:2009. 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 Repu
25、blic, 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, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endo
26、rsement notice The text of ISO 22717:2015 has been approved by CEN as EN ISO 22717:2015 without any modification. DIN EN ISO 22717:2016-05EN ISO 22717:2015 (E)3 ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies)
27、. The work of preparing International Standards 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
28、-governmental, in liaison with ISO, also take 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 describ
29、ed in the ISO/IEC Directives, Part 1. In particular 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
30、the possibility that some of the elements of 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 IS
31、O list of patent declarations received (see 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
32、 well as information about ISOs adherence to 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 227
33、17:2006), of which it constitutes a minor revision.DIN EN ISO 22717:2016-05EN ISO 22717:2015 (E)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.Microbio
34、logical risk analysis depends on several parameters 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 ot
35、her topical products, the detection of skin pathogens 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 ind
36、icators of faecal contamination e.g. Escherichia coli) suggest hygienic failure during the manufacturing process.DIN EN ISO 22717:2016-05EN ISO 22717:2015 (E)5 1 ScopeThis International Standard gives general guidelines for the detection and identification of the specified microorganism Pseudomonas
37、aeruginosa in cosmetic products. Microorganisms considered 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 microbiolo
38、gical risk analysis to determine the types of cosmetic product 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
39、 this International Standard is based on the detection of Pseudomonas aeruginosa 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 Pseudomonas
40、 aeruginosa, subcultures can be performed on non-selective 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 may not be appropriate in every detail for some products
41、 (e.g. certain water immiscible products). Other International Standards (ISO 18415) may be appropriate. 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 Normat
42、ive referencesThe 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 of the referenced document (including any amendments) ap
43、plies.ISO 21148:2005, Cosmetics Microbiology General instructions 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 (
44、including bacteriophages) activity3 Terms and definitionsFor 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 t
45、est to prepare the initial suspensionDIN EN ISO 22717:2016-05EN ISO 22717:2015 (E)6 3.3initial suspensionsuspension (or solution) of the sample in a defined volume of an appropriate enrichment broth3.4sample dilutiondilution of the initial suspension3.5specified microorganismaerobic mesophilic bacte
46、rium or yeast that is undesirable in a cosmetic product and is recognized as a skin pathogen species that may be harmful for human health or as an indication of hygienic failure in the manufacturing process3.6Pseudomonas aeruginosagram-negative rod, motile; smooth colonies pigmented brown or greenis
47、hNote 1 to entry: The main characteristics for identification are: growth on selective cetrimide agar medium, oxidase positive, production of diffusible fluorescent pigments and production of a soluble phenazine pigment (pyocyanin) in suitable media.Note 2 to entry: Pseudomonas aeruginosa may be iso
48、lated from a wide variety of environmental sources, especially in water and has a very high potential to spoil many different substrates. It may produce infections of human skin or eye area. It is undesirable in cosmetic products for its potential pathogenicity and its capacity to affect the physico-chemical properties of the cosmetic formula.3.7enrichment brothnon-selective liquid medium containing suitable neutralizers and/or dispersing agen
