EN ISO 24998-2008 en Plastics laboratory ware - Single-use Petri dishes for microbiological procedures《塑料实验室器皿 微生物过程用单用途皮氏培养皿》.pdf

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1、BS EN ISO24998:2008ICS 71.040.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDPlastics laboratoryware Single-usePetri dishes formicrobiologicalprocedures (ISO24998:2008)This British Standard was published under the authority of the Standards Policy and Strateg

2、y Committee on 31 March 2010 BSI 2010ISBN 978 0 580 58562 3Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 24998:2008National forewordThis British Standard is the UK implementation of EN ISO 24998:2008.It supersedes BS 611-2:1990 which is withdrawn.The UK participation in its pr

3、eparation was entrusted to TechnicalCommittee LBI/36/1, Laboratory Glass and Plastics Apparatus.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsib

4、le for its correct application. Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 24998November 2008ICS 71.040.20English VersionPlastics laboratory ware - Single-use Petri dishes formicrobiological procedures (ISO 24

5、998:2008)Matriel de laboratoire en matire plastique - Botes dePetri usage unique pour mthodes microbiologiques (ISO24998:2008)Laborgerte aus Kunststoff - Einmal-Petrischalen frmikrobiologische Verfahren (ISO 24998:2008)This European Standard was approved by CEN on 29 October 2008.CEN members are bou

6、nd to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN

7、 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status

8、as theofficial versions.CEN members are the national 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, Slova

9、kia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for

10、 CEN national Members.Ref. No. EN ISO 24998:2008: EBS EN ISO 24998:2008EN ISO 24998:2008 (E) 3 Foreword This document (EN ISO 24998:2008) has been prepared by Technical Committee ISO/TC 48 “Laboratory glassware and related apparatus“ in collaboration with Technical Committee CEN/TC 332 “Laboratory e

11、quipment“, the secretariat of which is held by DIN. 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 May 2009, and conflicting national standards shall be withdrawn at the latest by May 2009. Atten

12、tion 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

13、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, Slova

14、kia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 24998:2008 has been approved by CEN as EN ISO 24998:2008 without any modification. BS EN ISO 24998:2008ISO 24998:2008(E) ISO 2008 All rights reserved iiiContents Page Foreword iv 1 Scope . 1 2 Terms

15、and definitions. 1 3 Principle of use . 1 4 Types 2 5 Material 2 6 Design and construction 2 6.1 General. 2 6.2 Dimensions 2 6.3 Rim on lid. 3 6.4 Compartments. 3 6.5 Venting. 3 7 Performance 4 7.1 Rigidity. 4 7.2 Resistance to thermal distortion. 4 7.3 Resistance to fracture 4 7.4 Stability in stac

16、king 4 8 Limitation of contamination. 4 9 Sterility and special microbiological states. 4 10 Packaging 5 11 Marking 5 Annex A (normative) Type test for rigidity 6 Annex B (normative) Type test for resistance to thermal distortion 8 Annex C (normative) Type test for resistance to fracture 9 Annex D (

17、normative) Type test for stability in stacking. 10 Bibliography . 11 BS EN ISO 24998:2008ISO 24998:2008(E) iv ISO 2008 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparin

18、g 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-governmental, in liai

19、son with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of t

20、echnical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is d

21、rawn to 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. ISO 24998 was prepared by Technical Committee ISO/TC 48, Laboratory equipment, Subcommittee SC 6, Laboratory and vo

22、lumetric ware. BS EN ISO 24998:2008INTERNATIONAL STANDARD ISO 24998:2008(E) ISO 2008 All rights reserved 1Plastics laboratory ware Single-use Petri dishes for microbiological procedures 1 Scope This International Standard specifies requirements and test methods for plain, single-use Petri dishes for

23、 microbiological use. This International Standard does not apply to products of similar design which may be used for cell or tissue culture purposes. Neither does it apply to dishes supplied ready loaded with microbiological media. NOTE Petri dishes are used for microbiological routine purposes in v

24、ery large numbers and consequently, are often handled by robotic equipment. Users of such equipment should satisfy themselves that the Petri dishes of any given manufacturer are suitable for use with such equipment and, if obtained from several sources, are compatible if mixed. 2 Terms and definitio

25、ns For the purposes of this document, the following terms and definitions apply. 2.1 Petri dish combination of a dish with an accompanying loose-fitting lid, intended to preserve the microbiological integrity of its unused or in-use enclosed, interior space 2.2 dish shallow, cylindrical or square, o

26、pen-topped container comprising a plane base with an integral outer wall NOTE The dish can be subdivided with internal dividers to form separate compartments. 2.3 lid cover of similar shape to, and larger size than the dish, over which it is placed, inverted, to enclose a working volume NOTE The und

27、erside of the lid can incorporate one or more small protuberances (venting protrusions) to facilitate free circulation of environmental gases. Lids without such protrusions are designed to impede such free circulation. 3 Principle of use Under environmentally controlled conditions, selected to avoid

28、 introduction of unwanted micro-organisms, the lid of the Petri dish is lifted and a quantity of microbiologically nutrient medium introduced (poured) into the dish. The dish is recovered and allowed to equilibrate with a predetermined environment. Under similarly suitable conditions, the lid is lif

29、ted again and a sample under investigation is then introduced onto the medium in the dish. Following closure and a period of storage under predetermined conditions, growth of any microorganisms originating from the sample may have occurred, enabling further study. NOTE Attention is drawn to potentia

30、l national or regional regulations in respect of safe and environmentally compatible disposal of used Petri dishes. BS EN ISO 24998:2008ISO 24998:2008(E) 2 ISO 2008 All rights reserved4 Types Four types of dish are specified in this International Standard. Type A: circular dishes, without internal d

31、ividers, with or without venting protrusions in the lid Type B: circular dishes, with internal dividers, with or without venting protrusions in the lid Type C: square dishes, without internal dividers, with or without venting protrusions in the lid Type D: square dishes, with internal dividers, with

32、 or without venting protrusions in the lid NOTE There can be variants of Type A to Type D in respect of design and construction as given in Clause 6. In that case, detailed specifications are given by the manufacturer. 5 Material The Petri dish shall be made from microbiologically inert transparent

33、plastic and may be self-coloured for batch identification purposes, or colourless. The finished dish shall be free from colour variation or discolouration and physical defects such as striations which may impair its use in microbiology. 6 Design and construction 6.1 General When subjected to visual

34、examination, the Petri dish shall have no sharp edges, projection or surface roughness capable of cutting, puncturing or abrading the skin or gloves of the user, or damaging the packaging. The Petri dish shall be free of holes which would permit leakage or compromising of microbiological integrity.

35、The base of the dish and the closed face of the lid shall be planar, within the limits given in Table 1. 6.2 Dimensions The dimensions of the Petri dish shall conform to those given in Table 1 and, where applicable, to other detailed dimensions given in 6.3 to 6.5. NOTE Manufacturing techniques are

36、capable of yielding products conforming to very tight dimensional tolerances frequently closer than 0,02 mm on products of this order of size. It is for that reason, and to allow manufacturers freedom to innovate designs, that dimensional tolerances are not specified for the major dimensions in Tabl

37、e 1, but ranges are given from within which manufacturers may choose their basic dimensions. This also allows for innovative wall designs incorporating rims or multiple angles to facilitate automated handling. BS EN ISO 24998:2008ISO 24998:2008(E) ISO 2008 All rights reserved 3Table 1 Dimensions of

38、Petri dishes Dimensions in millimetres Range for external dimension of dish Type Nominal size Diameter Length of side Range for external height of dish Range for external height of lid Range for lateral clearance between lid and dish (assembled) at point of contact Flatness: maximum permitted depart

39、ure of base of dish and face of lid from plane A (circular) 60 54 to 65 13 to 17 7,5 to 10,5 1 to 3 1,0 90 85 to 91 13 to 17 7,5 to 10,5 1 to 3 1,0 100 95 to 105 13 to 17 7,5 to 10,5 1 to 3 1,5 A and B (circular) 140 138 to 144 13 to 21 7,5 to 10,5 2 to 4 1,5 100 101 to 104 17 to 21 7,5 to 10,5 1 to

40、 3 1,5 C and D (square) 120 121 to 129 13 to 21 7,5 to 10,5 2 to 4 1,5 The flatness (see Table 1) shall be measured as: the maximum distance between any part of the top face of the base and a horizontal plane touching that face; the maximum distance between any part of the top face of the lid and a

41、horizontal plane touching that face. 6.3 Rim on lid A slight rim may be provided on the outer, closed face of the lid, close to its circumference or, if square, its outer edge. This rim shall not exceed 1 mm in height. NOTE Such a rim is to discourage dishes within stacks from sliding over one anoth

42、er laterally. 6.4 Compartments If the dish has dividers to create internal compartments, the height of the dividers shall be between 50 % and 100 % of the height of the dish and shall not allow leakage between compartments. The number of compartments shall be stated in the labelling of primary packa

43、ging, see Clauses 10 and 11. 6.5 Venting As referred to in 2.3, one or more venting protuberances (protrusions) may be moulded on the inside face of the lid, close to its wall. Such venting protrusions shall extend radially from the wall to exceed the maximum lateral clearance possible between the e

44、dge of the dish and the lid. Single venting protrusion shall have a height within the range 0,12 mm to 0,35 mm. Multiple venting protrusions shall be symmetrically disposed on the lid and shall have a height within the range 0,25 mm to 0,7 mm. The provision of venting shall be designated by the lett

45、er “V” in the marking of primary packages. See Clauses 10 and 11. BS EN ISO 24998:2008ISO 24998:2008(E) 4 ISO 2008 All rights reserved7 Performance 7.1 Rigidity 7.1.1 Lid When tested by the method described in Annex A, the internal diameter (for Type A and B) or the internal width (for Type C and D)

46、 of the lid, measured in the direction of the applied force, shall not decrease by more than 1 mm. 7.1.2 Dish When tested by the method described in Annex A, the internal diameter (for Type A and B) or the internal width (for Type C and D) of the dish, measured in the direction of the applied force,

47、 shall not decrease by more than 2 mm. 7.2 Resistance to thermal distortion After being subjected to the test method described in Annex B, the dish shall retain the degree of flatness given in Table 1 and the dish shall not rock or spin on a flat surface. 7.3 Resistance to fracture 7.3.1 Lid When te

48、sted by the method described in Annex C, the lid shall neither fracture nor permanently deform under a load of 9,81 N. 7.3.2 Dish When tested by the method described in Annex C, the dish shall neither fracture nor permanently deform under a load of 7,36 N. 7.4 Stability in stacking When tested by th

49、e method described in Annex D, it shall be possible to tilt a stack of 10 Petri dishes at an angle of 12 from the vertical without the stack collapsing. 8 Limitation of contamination Petri dishes shall be free from contamination by loose particles greater than 100 m in diameter, as assessed by visual inspection by an observer with usual, or corrected-to-usual, vision without magnification, under a uniform illumination of 300 lx to 750 lx. 9 Sterility and special microbiological states If a manufacturer claims that an unopen

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