DIN EN ISO 24998-2009 Plastics laboratory ware - Single-use Petri dishes for microbiological procedures (ISO 24998 2008) English version of DIN EN ISO 24998 2009-03《塑料实验室器皿 微生物过程用单.pdf

1、March 2009DEUTSCHE NORM English price group 10No part of this standard 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 71.040.20!$VW“1515204www

2、.din.deDDIN EN ISO 24998Plastics laboratory ware Single-use Petri dishes for microbiological procedures (ISO 24998:2008)English version of DIN EN ISO 24998:2009-03Laborgerte aus Kunststoff Einmal-Petrischalen fr mikrobiologische Verfahren (ISO 24998:2008)Englische Fassung DIN EN ISO 24998:2009-03www

3、.beuth.deDocument comprises 16 pagesDIN EN ISO 24998:2009-03 2 National foreword This standard has been prepared by Technical Committee ISO/TC 48 “Laboratory equipment”, Subcommittee SC 6 “Laboratory and volumetric ware” in collaboration with Technical Committee CEN/TC 332 “Laboratory equipment” (Se

4、cretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Laborgerte und Laboreinrichtungen (Laboratory Devices and Installations Standards Committee), Technical Committee NA 055-01-08 AA Volumenmessgerte. EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NOR

5、MEN ISO 24998November 2008ICS 71.040.20English VersionPlastics laboratory ware - Single-use Petri dishes formicrobiological procedures (ISO 24998:2008)Matriel de laboratoire en matire plastique - Botes dePetri usage unique pour mthodes microbiologiques (ISO24998:2008)Laborgerte aus Kunststoff - Einm

6、al-Petrischalen frmikrobiologische Verfahren (ISO 24998:2008)This European Standard was approved by CEN on 29 October 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard witho

7、ut any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 language ma

8、de by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France,

9、 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 STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUN

10、GManagement Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 24998:2008: EContents Page 1 2 3 4 5 6 6.1 6.2 6.3 6.4 6.5 7 7.1 7.2 7.3 7.4 8 9 10 11 EN ISO 24998:2008 (E) 2DIN EN ISO

11、 24998:2009-03 Scope . 4 Terms and definitions. 4 Principle of use . 4 Types 5 Material 5 Design and construction 5 General. 5 Dimensions 5 Rim on lid. 6 Venting. 6 Compartments. 6 Performance 7 Resistance to thermal distortion. 7 Stability in stacking 7 Rigidity. 7 Resistance to fracture 7 Limitati

12、on of contamination. 7 Sterility and special microbiological states. 7 Packaging 8 Marking 8 Annex A (normative) Type test for rigidity 9 Annex D (normative) Type test for stability in stacking. 13 Bibliography . 14 Annex C (normative) Type test for resistance to fracture 12 Annex B (normative) Type

13、 test for resistance to thermal distortion 11 Foreword. 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 equipment“, the secretariat of which i

14、s 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. Attention is drawn to the possibility that

15、 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 the following countries are bound to

16、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, Slovakia, Slovenia, Spain, Sweden, Switzer

17、land 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. EN ISO 24998:2008 (E) 3DIN EN ISO 24998:2009-03 1 Scope This International Standard specifies requirements and test methods for plain, single-use Petri d

18、ishes for 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 purp

19、oses in very 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

20、definitions 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

21、square, open-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 NOT

22、E The underside 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

23、 to avoid 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 l

24、id is lifted 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

25、 potential national or regional regulations in respect of safe and environmentally compatible disposal of used Petri dishes. EN ISO 24998:2008 (E) 4DIN EN ISO 24998:2009-03 4 Types Four types of dish are specified in this International Standard. Type A: circular dishes, without internal dividers, wi

26、th 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 or without

27、 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 plastic and

28、 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 examination

29、, 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. The base of

30、 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 capable of

31、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 Table 1, but ra

32、nges 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. EN ISO 24998:2008 (E) 5DIN EN ISO 24998:2009-03 Table 1 Dimensions of Petri dishes Dimensions in mill

33、imetres 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 departure of base of dish and face of

34、 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 3 1,5 C and D (square) 120 121

35、 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 horizontal plane touching that

36、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 another laterally. 6.4 Compartments

37、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 packaging, see Clauses 10 and 11. 6.

38、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 edge of the dish and the lid. Si

39、ngle 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 letter “V” in the marking of primar

40、y packages. See Clauses 10 and 11. EN ISO 24998:2008 (E) 6DIN EN ISO 24998:2009-03 7 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) of the lid, measured in the direction of the appli

41、ed 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, shall not decrease by more than 2 mm. 7.2 Resistan

42、ce 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 tested by the method described in Annex C, the lid sh

43、all 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 the method described in Annex D, it shall be possible

44、 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 correcte

45、d-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 unopened and unused dish is sterile, or has a special microbiological state, the dish shall have been subjected to a validated p

46、rocess designed to achieve that claim. Validation of the sterilisation process is the responsibility of the manufacturer. NOTE 1 For the validation and routine control of sterilisation procedures, see ISO 11137-1 and ISO 17665-1. NOTE 2 For cleanrooms and associated controlled environments, see ISO

47、14644 (parts 1 to 8). EN ISO 24998:2008 (E) 7DIN EN ISO 24998:2009-03 10 Packaging Petri dishes shall be supplied, assembled, in sealed bags, the permeability of which shall be such as to prevent microbiological contamination of the dishes under usual conditions of storage and handling. All Petri di

48、shes shall be arranged with the same orientation with a maximum of 30 dishes in each bag. The bagged Petri dishes shall be assembled in quantities convenient for sale, storage and handling, in outer cartons (primary packaging) to protect the bags and minimize the risk of compromising the microbiolog

49、ical integrity of the Petri dishes. If the bags are made of polyethylene film, the thickness should be not less than 70 m. 11 Marking As appropriate, the primary packaging (outer cartons, see Clause 10) shall bear the following particulars, which may, where applicable, take the form of a symbol in accordance with regional or national standards: a) the name and address of the manufacturer; b) a description of the product detailing shape, and nominal dimension, whether vented and number of compartments, if subdivided e.g. “Petri dishes, circu