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

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1、BRITISH STANDARDCosmetics Microbiology General instructions for microbiological examinationICS 07.100.99; 71.100.70g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g4

2、3g55g3g47g36g58BS ISO EN21148:2009National forewordThis British Standard is the UK implementation of EN ISO 21148:2009. It is identical to ISO 21148:2005. It supersedes BS ISO 21148:2005 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CW/217, Cosmetics

3、.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from

4、 legal obligations.BS EN ISO 21148:2009This British Standard was published under the authority of the Standards Policy and Strategy Committee on 6 January 2006 BSI 2010Amendments/corrigenda issued since publicationDate Comments 31 January 2010 This corrigendum renumbers BS ISO 21148:2005 as BS EN IS

5、O 21148:2009ISBN 978 0 580 66831 9EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21148 June 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

6、les examens microbiologiques (ISO 21148:2005, Cor 1:2006 inclus) Kosmetik - Mikrobiologie - Allgemeine 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

7、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 Management Centre or to any CEN member. This Europea

8、n 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 Management Centre has the same status as the official versions. CEN members are the natio

9、nal standards bodies of 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, Slovakia, Slovenia, Spain, Sweden, Switzerland and U

10、nited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE 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

11、:2009: EForeword 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 - Undetermine

12、d” 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. Att

13、ention 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 o

14、f the 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, Slo

15、vakia, 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 21148:2005Contents Page2 5 7 8 9 10 11 12 Annex A (informative) Basic identificati

16、on techniques 14Neutralization of the antimicrobial properties of the product . 13Expression of results 13Operating practices . 12Laboratory samples 10Annex B (informative) Basic techniques for counting and plating . 19Annex C (informative) Preparation and calibration of inoculums . 20Preparation an

17、d 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 Introduction . ivBS EN ISO 21148:2009BS ISO 21148:2005Introduction The purpose of this International S

18、tandard is to help ensure that the general techniques used for conducting cosmetic microbiological examinations 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 l

19、aboratory personnel by preventing risk of infection. When conducting microbiological examinations for cosmetic 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 or

20、der to achieve this, it is necessary to pay attention to personal hygiene and to use working techniques which 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 micr

21、obiological examinations, a thorough knowledge of the microbiological techniques and of the microorganisms 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

22、example, unintentionally lead to cross-contamination and the analyst should always verify the accuracy of 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 t

23、o specify all the precautions to be taken in all circumstances, but this International Standard at least 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 microorgan

24、isms which may grow under aerobic conditions. The recommendations are applicable to the determination of 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 microbiologic

25、al procedures can be used provided that their equivalence has been demonstrated or the method has been otherwise 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

26、to decide which approach is best for his/her application. ivBS EN ISO 21148:2009BS ISO 21148:20051Cosmetics Microbiology General instructions for microbiological examination 1 Scope This International Standard gives general instructions for carrying out microbiological examinations of cosmetic produ

27、cts, in 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 f

28、or some 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 prod

29、uct (at 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

30、3 Premises 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, ino

31、culations, 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 21148:20052 3.2 Additional areas The areas included in this category are, for example: entrances, corridors, st

32、airways, 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 microbiological analyses are carried out shall not affect the reliability of the analyses. Care sh

33、all 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, vibration, exposure to direct sunlight, etc. The surface area shall be sufficiently large to k

34、eep 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 areas and/or specific enclosures should be provided for the following: receipt, storage and

35、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 Equipping the premises 3.4.1 The test premises shall be fitted out in the following ways in

36、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 in laboratories; overhead pipes conveying fluids should not cross the premises unless they ar

37、e hermetically enclosed; sun-protection systems, when used, shall be installed on the outside of the windows, where practicable; BS EN ISO 21148:2009BS ISO 21148:20053 windows and doors shall be able to be closed when conducting the test in order to minimize draughts. Furthermore, they shall be desi

38、gned so as to avoid the formation of dust traps and hence, to facilitate the cleaning. 3.4.2 The ambient temperature 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 microbi

39、ological cabinet are recommended for this purpose. 3.4.3 The laboratory bench tops and furniture shall be made 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 des

40、igned so as to facilitate cleaning the floors. It is desirable that documents or books that are not frequently 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 parti

41、cularly accumulate and thus cause a source of contamination. Regular cleaning and, when relevant, disinfection 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

42、when necessary. 4 Equipment 4.1 General In general, all equipment shall be kept clean and in proper working 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 Mic

43、robiological cabinets Cabinets are of two types: a) clean-air cabinets, which are intended to protect the product 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

44、protect the operator and the environment. Either cabinet can be used. Safety cabinets should be used for all 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 fi

45、lters. 4.3 Balances A microbiology laboratory for analyses of cosmetic products should be equipped with balances 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 me

46、dia and reagents, is 0,01 g. BS EN ISO 21148:2009BS ISO 21148:20054 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

47、 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 instructions and proper documentation should be recorded. The

48、 autoclave shall not be used to sterilize both clean materials and also to decontaminate used materials at the same time. Wherever possible, separate autoclaves for these two processes should be used. 4.7 Incubator Incubators shall be equipped with a regulation system which allows the temperature to

49、 be kept even and stable over their entire working volume. If the ambient temperature is close to, or higher than, that of the incubator, use an incubator with a cooling system. Incubators should be protected from direct sunlight. If possible, incubators should not be completely filled in one single operation because the culture media will take a long time to equilibrate to temperature, whatever type of incubator is used (forced-air convection or otherwise). The temperature shall be checked and recorded at least every workin