BS EN ISO 21148-2009 Cosmetics - Microbiology - General instructions for microbiological examination《化妆品 微生物学 微生物检查的一般说明书》.pdf

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2、or microbiological examinationICS 07.100.99; 71.100.70Cosmetics Microbiology General instructions BRITISH STANDARDBS ISO EN21148:2009BS EN ISO 21148:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 21/04/2010 03:05, Uncontrolled Copy, (c) BSIThis British Standard was published under the au

3、thority of the Standards Policy and Strategy Committee on 6 January 2006 BSI 2010ISBN 978 0 580 66831 9Amendments/corrigenda issued since publicationDate Comments 31 January 2010 This corrigendum renumbers BS ISO 21148:2005 as BS EN ISO 21148:2009This publication does not purport to include all the

4、necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.National forewordThis British Standard is the UK implementation of EN ISO 21148:2009. It is identical to ISO 21148:2005. It supersede

5、s BS ISO 21148:2005 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CW/217, Cosmetics.A list of organizations represented on this committee can be obtained on request to its secretary.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21148 June

6、2009 ICS 07.100.99; 71.100.70 English Version Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2005) Cosmtiques - Microbiologie - Instructions gnrales pour les examens microbiologiques (ISO 21148:2005, Cor 1:2006 inclus) Kosmetik - Mikrobiologie - Allgemeine

7、 Anleitungen fr mikrobiologische Untersuchungen (ISO 21148:2005) This European Standard was approved by CEN on 23 May 2009. 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 wit

8、hout any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other languag

9、e made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,

10、 France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMIT

11、EE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21148:2009: ELicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 21/04/2010 03:05, Uncontrolled Copy, (c

12、) BSIForeword The text of ISO 21148:2005 has been prepared by Technical Committee ISO/TC 217 “Cosmetics” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 21148:2009 by Technical Committee CEN/SS H99 “Products for household and leisure use - Undetermined”

13、the secretariat of which is held by CMC. 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 2009, and conflicting national standards shall be withdrawn at the latest by December 2009. Attent

14、ion 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. According to the CEN/CENELEC Internal Regulations, the national standards organizations of t

15、he following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovak

16、ia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 21148:2005 has been approved by CEN as a EN ISO 21148:2009 without any modification. ii BS EN ISO 21148:2009BS ISO 21148:2005Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 21/04/2010 03:05, Un

17、controlled Copy, (c) BSIContents Page2 5 7 8 9 10 11 12 Annex A (informative) Basic identification techniques 14Neutralization of the antimicrobial properties of the product . 13Expression of results 13Operating practices . 12Laboratory samples 10Annex B (informative) Basic techniques for counting a

18、nd plating . 19Annex C (informative) Preparation and calibration of inoculums . 20Preparation and sterilization of culture media and reagents 8Preparation of the apparatus and glassware 66 Personnel . 6Strains of microorganisms . 64 Equipment 33 Premises . 1Terms and definitions 11 Scope 1iii Introd

19、uction . ivBS EN ISO 21148:2009BS ISO 21148:2005Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 21/04/2010 03:05, Uncontrolled Copy, (c) BSIIntroduction The purpose of this International Standard is to help ensure that the general techniques used for conducting cosmetic microbiological examin

20、ations are the same in other laboratories that adopt these standards, to help achieve homogeneous results in different laboratories and to contribute towards the protection of the health of the laboratory personnel by preventing risk of infection. When conducting microbiological examinations for cos

21、metic products, it is especially important that: only those microorganisms which are present in the samples be isolated or enumerated; the microorganisms do not contaminate the environment. In order to achieve this, it is necessary to pay attention to personal hygiene and to use working techniques w

22、hich ensure, as far as possible, exclusion of extraneous contamination. Since, in this International Standard it is possible to give only a few examples of the precautions to be taken during microbiological examinations, a thorough knowledge of the microbiological techniques and of the microorganism

23、s involved is essential. It is important that the analyses be conducted as accurately as possible, including calculation of the number of microorganisms. A large number of manipulations can, for example, unintentionally lead to cross-contamination and the analyst should always verify the accuracy of

24、 the results given by his/her technique. It is necessary to take special precautions, not only for reasons of hygiene, but also to ensure good reproducibility of the results. It is not possible to specify all the precautions to be taken in all circumstances, but this International Standard at least

25、provides the main measures to be taken when preparing, sterilizing and storing the media and the equipment. The given recommendations will allow enumeration and detection of mesophilic microorganisms which may grow under aerobic conditions. The recommendations are applicable to the determination of

26、the absence of, or limited occurrence of specified microorganisms that are of interest for cosmetic products. The test methods are described in the individual standards. Alternative microbiological procedures can be used provided that their equivalence has been demonstrated or the method has been ot

27、herwise validated. The choice of a specific method, or combination of methods mentioned in these International Standards will depend on the purpose for performing the test and it is for the user to decide which approach is best for his/her application. ivBS EN ISO 21148:2009BS ISO 21148:2005Licensed

28、 Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 21/04/2010 03:05, Uncontrolled Copy, (c) BSI1Cosmetics Microbiology General instructions for microbiological examination 1 Scope This International Standard gives general instructions for carrying out microbiological examinations of cosmetic products, i

29、n order to ensure their quality and safety, in accordance with an appropriate risk analysis (e.g. low water activity, hydro-alcoholic, extreme pH values). Because of the large variety of products and potential uses within this field of application, these instructions might not be appropriate for som

30、e products in every detail (e.g. certain water-immiscible products). 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 product portion of an identified cosmetic product received in the laboratory for testing 2.2 sample portion of the product (a

31、t least 1 g or 1 ml) which is used in the test to prepare the initial suspension 2.3 initial suspension suspension (or solution) of a sample in a defined volume of an appropriate liquid (diluent, neutralizer, broth or combination of them) 2.4 sample dilution dilution of the initial suspension 3 Prem

32、ises 3.1 Test areas The areas required for the specific operation of a microbiology laboratory are as follows: receipt, storage, preparation and processing of the samples; preparation and sterilization of culture media, apparatus and glassware; performance of analyses: weighing, dilutions, inoculati

33、ons, subculturing, incubation, maintenance of the strain, etc.; decontamination and cleaning of apparatus, glassware, and processing of the analysis waste. BS EN ISO 21148:2009BS ISO 21148:2005Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 21/04/2010 03:05, Uncontrolled Copy, (c) BSI2 3.2 Ad

34、ditional areas The areas included in this category are, for example: entrances, corridors, stairways, lifts; administrative areas (e.g. secretarial, offices, documentation rooms, etc.); cloakrooms and toilets; archive rooms; stores. 3.3 Location of the premises The environment within which the micro

35、biological analyses are carried out shall not affect the reliability of the analyses. Care shall be taken to locate the premises so as to avoid risk of cross-contamination. Care shall be taken to ensure protection against extreme conditions such as excess temperature, dust, humidity, steam, noise, v

36、ibration, exposure to direct sunlight, etc. The surface area shall be sufficiently large to keep the work areas clean and orderly. During the course of the tests, care shall be taken to limit access to the test areas to only those persons required to conduct the tests. Separate rooms and/or separate

37、 areas and/or specific enclosures should be provided for the following: receipt, storage and preparation of samples; manipulation of microbial cultures; preparation of culture media, apparatus and glassware; decontamination and washing area; sterilization; incubators, refrigerators and freezers. 3.4

38、 Equipping the premises 3.4.1 The test premises shall be fitted out in the following ways in order to reduce the risks of contamination by dust and therefore by microorganisms: walls, ceilings and floors should be smooth, non-porous, easy to clean, and resistant to detergents and disinfectants used

39、in laboratories; overhead pipes conveying fluids should not cross the premises unless they are hermetically enclosed; sun-protection systems, when used, shall be installed on the outside of the windows, where practicable; BS EN ISO 21148:2009BS ISO 21148:2005Licensed Copy: Wang Bin, ISO/EXCHANGE CHI

40、NA STANDARDS, 21/04/2010 03:05, Uncontrolled Copy, (c) BSI3 windows and doors shall be able to be closed when conducting the test in order to minimize draughts. Furthermore, they shall be designed so as to avoid the formation of dust traps and hence, to facilitate the cleaning. 3.4.2 The ambient tem

41、perature and air quality (microorganism content, humidity, dust-spreading rate, etc.) shall be compatible with carrying out the tests. According to needs, a filter-ventilation and/or a microbiological cabinet are recommended for this purpose. 3.4.3 The laboratory bench tops and furniture shall be ma

42、de of smooth, non-porous impermeable materials, which are easy to clean and disinfect. Cabinet and equipment tops should be accessible for cleaning. Non-fixed laboratory furniture shall be designed so as to facilitate cleaning the floors. It is desirable that documents or books that are not frequent

43、ly used be kept outside the test areas. 3.5 Maintenance The floors, walls, ceiling, laboratory bench tops and furniture shall be maintained in good order to avoid cracks where dirt might particularly accumulate and thus cause a source of contamination. Regular cleaning and, when relevant, disinfecti

44、on shall be carried out in order to keep the premises in a condition suitable for conducting tests. The ventilation systems and their filters shall be regularly maintained and filters changed when necessary. 4 Equipment 4.1 General In general, all equipment shall be kept clean and in proper working

45、condition. Maintenance operations should be monitored. The measurement instruments and apparatus shall be regularly verified according to an appropriate timetable and results recorded. 4.2 Microbiological cabinets Cabinets are of two types: a) clean-air cabinets, which are intended to protect the pr

46、oduct from extraneous contamination and to minimize contamination due to the operator; b) safety cabinets, which are intended to protect the product from extraneous contamination, and also to protect the operator and the environment. Either cabinet can be used. Safety cabinets should be used for all

47、 work involving risk for the operator. A cabinet is a dust-free workstation equipped with vertical laminar airflow. In microbiology, a safety cabinet is used to retain the microorganisms on filters. 4.3 Balances A microbiology laboratory for analyses of cosmetic products should be equipped with bala

48、nces of the required range and accuracy for the different products to be weighed. Generally, the accuracy required for weighing the samples to be analysed and some components of the culture media and reagents, is 0,01 g. BS EN ISO 21148:2009BS ISO 21148:2005Licensed Copy: Wang Bin, ISO/EXCHANGE CHIN

49、A STANDARDS, 21/04/2010 03:05, Uncontrolled Copy, (c) BSI4 4.4 Homogenizer This equipment (e.g. blender, stomacher, etc.) may be used to prepare the initial suspension from the test samples of non-liquid products. 4.5 pHmeter The pH-meter should be capable of measuring to an accuracy of 0,1 pH units and its minimum measuring threshold shall be 0,01 pH units. 4.6 Autoclave The autoclave shall be kept in good operating condition and shall regularly be inspected by the competent departments in accordance with the manufacturers