1、September 2017 English price group 14No 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 07.100.40!%mto“2748176www.din.
2、deDIN EN ISO 18415Cosmetics Microbiology Detection of specified and nonspecified microorganisms (ISO 18415:2017);English version EN ISO 18415:2017,English translation of DIN EN ISO 18415:2017-09Kosmetische Mittel Mikrobiologie Nachweis von spezifizierten und nichtspezifizierten Mikroorganismen (ISO
3、18415:2017);Englische Fassung EN ISO 18415:2017,Englische bersetzung von DIN EN ISO 18415:2017-09Cosmtiques Microbiologie Dtection des microorganismes spcifis et non spcifis (ISO 18415:2017);Version anglaise EN ISO 18415:2017,Traduction anglaise de DIN EN ISO 18415:2017-09SupersedesDIN EN ISO 18415:
4、201108www.beuth.deDocument comprises 29 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.09.17 DIN EN ISO 18415:2017-09 2 A comma is used as the decimal marker. National foreword This document (EN ISO 18415:2017) has been prepar
5、ed by Technical Committee ISO/TC 217 “Cosmetics” (Secretariat: 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 (DI
6、N Standards Committee Food and Agricultural Products), Working Committee NA 057-07-01 AA “Cosmetics”. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 16212 DIN EN ISO 16212 ISO 18416 DIN EN ISO 18416 ISO 21148:2017 DIN EN ISO 21148:2017
7、 ISO 21149 DIN EN ISO 21149 ISO 21150 DIN EN ISO 21150 ISO 22717 DIN EN ISO 22717 ISO 22718 DIN EN ISO 22718 ISO 29621 DIN EN ISO 29621 Amendments This standard differs from DIN EN ISO 18415:2011-08 as follows: a) Normative references have been updated; b) the term “validation” has been replaced thr
8、oughout the text by “suitability”; c) in the Scope, “see ISO 29621” has been added and the reference has been added to the Bibliography; d) in the Scope, “used” has been changed to “substituted” and “validated” has been changed to “shown to be suitable”; e) in 3.8, “validated” has been changed to “d
9、emonstrated to be suitable”; f) in Clause 4, “validated” has been changed to “demonstrated”; g) in Clause 5.1, “specifications” has been changed to “instructions”; h) in 5.1, “are validated” has been changed to “have been demonstrated to be suitable”; i) in 5.2.1, 5.3.3.1, 11.3.1, 11.3.2 and in the
10、heading of 11.3.3, instances of the term “validation” have been changed to “suitability test”; j) in 11.3, the term “validation” in the heading title has been changed to “suitability”; k) in 11.3.3, “validated” has been changed to “satisfactory”; l) in Clause 12 f), the term “validation” has been ch
11、anged to “demonstration of the suitability”; m) the standard has been editorially revised. Previous editions DIN EN ISO 18415: 2011-08 DIN EN ISO 18415:2017-09 3 National Annex NA (informative) Bibliography DIN EN ISO 16212, Cosmetics Microbiology Enumeration of yeast and mould DIN EN ISO 18416, Cos
12、metics Microbiology Detection of Candida albicans DIN EN ISO 21148:2017, Cosmetics Microbiology General instructions for microbiological examination DIN EN ISO 21149, Cosmetics Microbiology Enumeration and detection of aerobic mesophilic bacteria DIN EN ISO 21150, Cosmetics Microbiology Detection of
13、 Escherichia coli DIN EN ISO 22717, Cosmetics Microbiology Detection of Pseudomonas aeruginosa DIN EN ISO 22718, Cosmetics Microbiology Detection of Staphylococcus aureus DIN EN ISO 29621, Cosmetics Microbiology Guidelines for the risk assessment and identification of microbiologically low-risk prod
14、ucts DIN EN ISO 18415:2017-09 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18415 June 2017 ICS 07.100.40 Supersedes EN ISO 18415:2011English Version Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (ISO 18415:2017) Cosm
15、tiques - Microbiologie - Dtection des micro-organismes spcifis et non spcifis (ISO 18415:2017)Kosmetische Mittel - Mikrobiologie - Nachweis von spezifizierten und nichtspezifizierten Mikroorganismen (ISO 18415:2017) This European Standard was approved by CEN on 26 April 2017. CEN members are bound t
16、o 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 obtained on application to the CEN-C
17、ENELEC 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 CEN-CENELEC Management Centre has
18、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, Ireland, Italy, Latvia, Lithuania, Luxe
19、mbourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-10
20、00 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 18415:2017 EEuropean foreword .4Introduction .61 Scope 72 Normative references . 73 Terms and definitions 74 Principle . 95 Diluents and culture media 95.1 Genera
21、l 95.2 Diluent for the microbial suspension (tryptone sodium chloride solution) 95.2.1 General. 95.2.2 Composition . 105.2.3 Preparation . 105.3 Culture media . 105.3.1 General 105.3.2 Enrichment broth 105.3.3 Non-selective agar medium 116 Apparatus and glassware 117 Strains of microorganism 128 Han
22、dling of cosmetic products and laboratory samples 129 Procedure. 129.1 General recommendations 129.2 Preparation of the initial suspension in the enrichment broth 129.2.1 General 129.2.2 Water-miscible products. 139.2.3 Water-immiscible products 139.2.4 Filterable products . 139.3 Incubation of the
23、initial suspension . 139.4 Isolation of specified and non-specified microorganisms . 139.5 Procedure for identification of the specified microorganism: Pseudomonas aeruginosa . 139.5.1 Gram staining 139.5.2 Oxidase test 139.5.3 Identification test 149.6 Procedure for identification of the specified
24、microorganism: Escherichia coli . 149.6.1 Gram staining 149.6.2 Oxidase test 149.6.3 Identification test 149.7 Procedure for identification of the specified microorganism: Staphylococcus aureus . 149.7.1 Gram staining 149.7.2 Catalase test . 149.7.3 Identification test 149.8 Procedure for the identi
25、fication of the specified microorganism: Candida albicans . 159.8.1 Gram staining 159.8.2 Identification test 159.9 Procedure for the identification of non-specified microorganisms 159.9.1 Gram staining 159.9.2 Oxidase test 159.9.3 Catalase test . 159.9.4 Identification test 15Contents PageForeword
26、.5DIN EN ISO 18415:2017-09 EN ISO 18415:2017 (E) 2 10.2 Detection of non-specified microorganisms. 1610.3 Absence of microorganisms 1611 Neutralization of the antimicrobial properties of the product .1611.1 General . 1611.2 Preparation of inoculum 1611.3 Suitability of detection method by enrichment
27、 .1611.3.1 Principle . 1611.3.2 Procedure 1711.3.3 Interpretation of suitability test results .1712 Test report 17Annex A (informative) General scheme for identification of microorganisms19Annex B (informative) Other media .20Annex C (informative) Neutralizers of antimicrobial activity of preservati
28、ves and rinsing liquids 23Bibliography .2510 Expression of the results .1610.1 Detection of specified microorganisms 16DIN EN ISO 18415:2017-09 EN ISO 18415:2017 (E) 3European foreword This document (EN ISO 18415:2017) has been prepared by Technical Committee ISO/TC 217 “Cosmetics“ in collaboration
29、with Technical Committee CEN/TC 392 “Cosmetics” 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 December 2017 and conflicting national standards shall be
30、 withdrawn at the latest by December 2017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 18415:2011. According to t
31、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,
32、Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 18415:2017 has been approved by CEN as EN ISO 18415:2017 w
33、ithout any modification. DIN EN ISO 18415:2017-09 EN ISO 18415:2017 (E) 4 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 tec
34、hnical 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 take part in the work. ISO collaborates closel
35、y 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 particular the different approval criteria ne
36、eded 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 of this document may be the subject of pat
37、ent 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 www .iso .org/ patents).Any trade name u
38、sed in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to t
39、he World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This document was prepared by Technical Committee ISO/TC 217, Cosmetics.This second edition cancels and replaces the first edition (ISO 18415:2007), of whic
40、h it constitutes a minor revision with the following changes: in the Scope, “see ISO 29621” has been added and the reference has been added to the Bibliography; in the Scope, “used” has been changed to “substituted” and “validated” has been changed to “shown to be suitable”; in 3.8, the term “valida
41、ted” has been changed to “demonstrated to be suitable”; in Clause 4, the term “validated” has been changed to “demonstrated”; in 5.1, “specifications” has been changed to “instructions”; in 5.1, the phrase “are validated” has been changed to “have been demonstrated to be suitable”; in 5.2.1, 5.3.3.1
42、, 11.3.1, 11.3.2, instances of the term “validation” and in the heading title of 11.3.3 have been changed to “suitability test”; in 11.3, the term “validation” in the heading title has been changed to “suitability”; in 11.3.3, instances of “validated” have been changed to “satisfactory”; in Clause 1
43、2 f), the term “validation” has been changed to “demonstration of the suitability”.DIN EN ISO 18415:2017-09 EN ISO 18415:2017 (E) 5 IntroductionMicrobiological examinations of cosmetic products are carried out according to an appropriate microbiological risk analysis in order to ensure their quality
44、 and safety for consumers.Microbiological risk analysis depends on several parameters such as: potential alteration of cosmetic products; pathogenicity of microorganisms; site of application of the cosmetic product (hair, skin, eyes, mucous membranes); type of user (adults, children including under
45、3 years).For cosmetics and other 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 infection. The detection of other kinds of microorganisms might be of interest since these
46、microorganisms (including indicators of faecal contamination e.g. Escherichia coli) suggest hygienic failure during manufacturing process.DIN EN ISO 18415:2017-09 EN ISO 18415:2017 (E) 6 1 ScopeThis document gives general guidelines for the detection and identification of specified microorganisms in
47、 cosmetic products as well as for the detection and identification of other kinds of aerobic mesophilic non-specified microorganisms in cosmetic products.Microorganisms considered as specified in this document might differ from country to country according to national practices or regulations. Most
48、of them considered as specified microorganisms include one or more of the following species: Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Candida albicans.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 products to which this document is applicable. Products considered to presen
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