DIN EN ISO 13079-2011 Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method (ISO 13079 2011) German version .pdf

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1、October 2011 Translation by DIN-Sprachendienst.English price group 11No 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).IC

2、S 71.040.20!$t_“1819260www.din.deDDIN EN ISO 13079Laboratory glass and plastics ware Tubes for the measurement of the erythrocyte sedimentation rate by theWestergren method (ISO 13079:2011)English translation of DIN EN ISO 13079:2011-10Laborgerte aus Glas und Kunststoff Westergren-Rohre fr die Eryth

3、rozyten-Sedimentationsgeschwindigkeit (ISO 13079:2011)Englische bersetzung von DIN EN ISO 13079:2011-10Matriel de laboratoire en verre et en plastique Tubes pour le mesurage de la vitesse de sdimentation des rythrocytes par la mthodeWestergren (ISO 13079:2011)Traduction anglaise de DIN EN ISO 13079:

4、2011-10SupersedesDIN 12845:1972-04www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.2009.11 DIN EN ISO 13079:2011-10 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee IS

5、O/TC 48 “Laboratory equipment” in collaboration with Technical Committee CEN/TC 332 “Laboratory equipment”, both secretariats are held by DIN, Germany. The responsible German body involved in its preparation was the Normenausschuss Laborgerte und Laboreinrichtungen (Laboratory Devices and Installati

6、ons Standards Committee), Working Committee NA 055-01-08 AA Volumenmessgerte. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 719 DIN ISO 719 ISO 15223-1 E DIN EN ISO 15223-1 Amendments This standard differs from DIN 12845:1972-04 as fo

7、llows: a) plastics has been included as material for Westergren tubes; b) single-use Westergren tubes have been added; c) requirements have been extended and given in more detail; d) three type tests have been specified in Annexes A, B and C; e) the Westergren reference method is described in an inf

8、ormative Annex D. Previous editions DIN 12845: 1972-04 National Annex NA (informative) Bibliography DIN ISO 719, Glass Hydrolytic resistance of glass grains at 98 C Method of test and classification E DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and in

9、formation to be supplied Part 1: General requirements EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13079 July 2011 ICS 11.100.10 English Version Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method (ISO 13079:2011)

10、Matriel de laboratoire en verre et en plastique - Tubes pour le mesurage de la vitesse de sdimentation des rythrocytes par la mthode Westergren (ISO 13079:2011)Laborgerte aus Glas und Kunststoff - Westergren-Rohre fr die Erythrozyten-Sedimentationsgeschwindigkeit (ISO 13079:2011) This European Stand

11、ard was approved by CEN on 14 July 2011. 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 without any alteration. Up-to-date lists and bibliographical references concerning suc

12、h national standards may be obtained on application to the CEN-CENELEC 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

13、 language and notified to the CEN-CENELEC Management Centre has 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy

14、, 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 KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000

15、Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13079:2011: EContents 2 DIN EN ISO 13079:2011-10 EN ISO 13079:2011 (E) Page 1 Scope 4 2 Normative references 4 3 Material .4 3.1 General4 3.2 Glass .4 3.3 Plastics .

16、5 4 Single-use Westergren tubes .5 4.1 General design.5 4.2 Straightness .5 4.3 Finish 5 4.4 Dimensions.5 4.5 Graduation and figuring6 4.6 Inscriptions.6 4.7 Labelling .6 5 Re-usable Westergren tubes 6 5.1 General design.6 5.2 Straightness .7 5.3 Finish 7 5.4 Dimensions.7 5.5 Graduation and figuring

17、7 5.6 Inscriptions.7 5.7 Labelling .7 6 Support for Westergren tubes8 6.1 Construction.8 6.2 Graduation and figuring9 6.3 Inscriptions.9 7 Graduation and figuring9 7.1 Graduation9 7.2 Figuring of graduation lines .10 8 Marking .10 9 Labelling .10 9.1 Single-use Westergren tubes .10 9.2 Re-usable Wes

18、tergren tubes 10 Annex A (normative) Type test for rigidity of Westergren tubes .12 Annex B (normative) Type test for contamination and interfering substances .13 Annex C (normative) Type test for straightness of Westergren tubes14 Annex D (informative) Measurement of the erythrocyte sedimentation r

19、ate by the Westergren reference method.16 Bibliography 18 Foreword3Foreword This document (EN ISO 13079:2011) has been prepared by Technical Committee ISO/TC 48 “Laboratory equipment” in collaboration with Technical Committee CEN/TC 332 “Laboratory equipment” the secretariat of which is held by DIN.

20、 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 January 2012, and conflicting national standards shall be withdrawn at the latest by January 2012. Attention is drawn to the possibility that some

21、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 implem

22、ent this European Standard: Austria, Belgium, Bulgaria, Croatia, 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, Swit

23、zerland and the United Kingdom. Endorsement notice The text of ISO 13079:2011 has been approved by CEN as a EN ISO 13079:2011 without any modification. 3 DIN EN ISO 13079:2011-10 EN ISO 13079:2011 (E) 1 Scope This International Standard specifies requirements for single-use and re-usable glass and p

24、lastics tubes for measuring the erythrocyte sedimentation rate (ESR) by the Westergren method, and for a support to hold tubes during the performance of the test. These so-called “Westergren tubes” are also sometimes designated as “Westergren pipettes”. A procedure for measuring the erythrocyte sedi

25、mentation rate by the Westergren method is given in informative Annex D. This International Standard does not apply to single-use containers for human venous blood specimen collection and their accessories for which other standards apply. It also does not apply for devices where the Westergren metho

26、d has been used as basis to develop other, similar methods or equipment for the erythrocyte sedimentation rate determination. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For un

27、dated references, the latest edition of the referenced document (including any amendments) applies. ISO 719, Glass Hydrolytic resistance of glass grains at 98 C Method of test and classification 3 Material 3.1 General 3.1.1 Westergren tubes shall be made from rigid, transparent plastics or from glas

28、s of Class HGB 1, HGB 2 or HGB 3 in accordance with ISO 719 so that: a) the rigidity, when tested according to Annex A, shall be such that the distortion does not exceed 1 mm for re-usable Westergren tubes and 1,5 mm for single-use Westergren tubes; b) the transparency shall be sufficient to permit

29、the top of the column of blood and the top of the red cell layer to be seen clearly in relation to the scale. 3.1.2 Westergren tubes shall be free from defects which impair observation of the top of the column of blood and of the top of the red cell layer. 3.2 Glass The manufacturer of the glass tub

30、es should ensure that the glass tubes are as free as possible from visible defects and reasonably free from internal stress. DIN EN ISO 13079:2011-10 EN ISO 13079:2011 (E) 4 3.3 Plastics 3.3.1 The material of which plastics tubes are made shall not affect the ESR value, when tested in accordance wit

31、h the method described in Annex B, by more than 6 mm. 3.3.2 The manufacturer of the plastics tubes shall ensure the following: a) they shall not show adhesive properties towards blood cells; b) they shall not release plasticizers that might alter sedimentation; c) if a mould-release agent is used in

32、 the manufacturing process, it shall not alter sedimentation. 3.3.3 The user should also check the validity of a batch of plastics tubes by comparing the ESR obtained when the test is performed using some of these with the results when glass reference tubes are used. 4 Single-use Westergren tubes 4.

33、1 General design The general design of the single-use Westergren tube shall be as shown in Figure 1. 4.2 Straightness The tube shall be straight when tested in accordance with the method described in Annex C. 4.3 Finish 4.3.1 The glass tube shall be cut square (within 10) with the axis of the tube,

34、and shall be lightly fire polished at each end. The ends may be slightly narrowed within or close to the tolerance given in Table 1, due to the finishing process. 4.3.2 The plastics tube should be cut square (within 10) with the axis of the tube. The ends should be smooth and may be slightly bevelle

35、d. Other ends are acceptable if they comply with the dimensional requirements as specified in Table 1. 4.3.3 The tube shall be supplied free from any contamination which would affect the ESR value when tested in accordance with the method described in Annex B. 4.3.4 The tube, by itself or in associa

36、tion with its support, shall have a mechanism which ensures that the tube remains filled with blood, from its lower end to the zero mark on the scale, during the 60 min required to determine the ESR. 4.4 Dimensions The measuring part of the tube shall conform to the dimensions given in Table 1. Tabl

37、e 1 Essential dimensions of single-use Westergren tubes Dimensions in millimetres Internal diameter 2,55 0,15 Length of measuring part 200 2 DIN EN ISO 13079:2011-10 EN ISO 13079:2011 (E) 5 4.5 Graduation and figuring Graduation or figuring shall be in accordance with Clause 7. 4.6 Inscriptions Insc

38、riptions on the Westergren tube shall be in accordance with Clause 8. 4.7 Labelling Inscriptions on the packaging shall be in accordance with 9.1. Dimensions in millimetres Key 1 tube with scale 2 tube with scale on support Figure 1 Single-use Westergren tubes 5 Re-usable Westergren tubes 5.1 Genera

39、l design The general design of a re-usable Westergren tube shall be as shown in Figure 2. DIN EN ISO 13079:2011-10 EN ISO 13079:2011 (E) 6 5.2 Straightness The tube shall be straight when tested in accordance with the method described in Annex C. 5.3 Finish 5.3.1 The upper end of the tube shall be g

40、round smooth and cut square with the axis of the tube, and shall be slightly bevelled, finely ground, polished or hot calendered. 5.3.2 The lower end of the tube shall be tapered as shown in Figure 2; the tapered portion shall be cut square with the axis of the tube and shall be finely ground, polis

41、hed or hot calendered. 5.3.3 The specified bore of the tube shall be maintained throughout, and shall not be drawn down to form the jet. If jet and upper end of the tube are calendered, they may slightly narrow. 5.4 Dimensions The tube shall conform to the dimensions given in Table 2. Table 2 Dimens

42、ions of re-usable Westergren tubes Dimensions in millimetres Overall length 300 2 External diameter 6,5 0,5 Internal diameter (bore) 2,55 0,15 Length of measuring part 200 2 Length of tapering portion 6 2 Wall thickness of orifice at least 0,5 5.5 Graduation and figuring Graduation and figuring shal

43、l be in accordance with Clause 7. All graduation and markings on re-usable Westergren tubes shall be clean and permanent. 5.6 Inscriptions Inscriptions on the re-usable Westergren tube shall be in accordance with Clause 8. Additionally, the inscription “re-usable Westergren ESR tube” may be inscribe

44、d. 5.7 Labelling Inscriptions on the packaging shall be in accordance with 9.2. DIN EN ISO 13079:2011-10 EN ISO 13079:2011 (E) 7 Dimensions in millimetres Key 1 scale graduated every millimetre, numbered downwards every centimetre 2 length of taper 4 mm to 8 mm, wall at orifice minimum 0,5 mm Figure

45、 2 Re-usable Westergren tubes 6 Support for Westergren tubes 6.1 Construction 6.1.1 The support shall be a rigid structure having clips or holes to hold rigidly one or several Westergren tubes in vertical position. The support shall stand on at least three feet, at the least two of which shall be ad

46、justable. NOTE The adjustable feet and an optional plumb-line or spirit-level permit adjustment that the tubes are held in vertical position. Vibration-free positioning of the support enables correct measurements. 6.1.2 When erythrocyte sedimentation rates are to be measured against scales marked on

47、 the support, the scales shall be marked on a surface fixed vertically behind the tubes and not more than 10 mm from each tube. 6.1.3 The support may be supplied with an automatic reading of the ESR value. 6.1.4 The support shall be constructed of such materials, and in such a way, that it is able t

48、o withstand repeated disinfection in the laboratory. DIN EN ISO 13079:2011-10 EN ISO 13079:2011 (E) 8 6.2 Graduation and figuring 6.2.1 Scales, figuring and inscriptions shall be provided on the support, if not marked on the tubes, and shall conform to Clause 7. NOTE A re-usable tube is intended for

49、 use with an appropriate support forming a system. The distribution of markings between tube and support can differ between one system and another. 6.2.2 Markings on the support shall be permanent. 6.2.3 When scales are provided on a support, they shall be fixed behind every tube, within 10 mm of the tube, as shown in Figure 1. 6.3 Inscriptions Inscriptions shall be permanent and shall conform to Clause 8. The following additional inscriptions shall be marked: a) the recommended method for the disinfection of the support a