EN ISO 13079-2011 en Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method《实验室玻璃和塑料制品 通过韦斯特格伦氏法测量红细胞沉降率所用试管》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 13079:2011Laboratory glass andplastics ware Tubes forthe measurement of theerythrocyte sedimentation rateby the Westergren method (ISO13079:2011)BS EN ISO 13079:2011 BR

2、ITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO13079:2011. It supersedes BS 2554:1987 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee LBI/36, Laboratory glassware and related apparatus. A list of organizations rep

3、resented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011 ISBN 978 0 580 68041 0 ICS 11.100.10; 71.040.20 Compliance with a British Standard

4、cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 August 2011. Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13079 July 201

5、1 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) Matriel de laboratoire en verre et en plastique - Tubes pour le mesurage de la vitesse de sdimentation des rythrocytes par la

6、 mthode Westergren (ISO 13079:2011)Laborgerte aus Glas und Kunststoff - Westergren-Rohre fr die Erythrozyten-Sedimentationsgeschwindigkeit (ISO 13079:2011) This European Standard was approved by CEN on 14 July 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stip

7、ulate 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-CENELEC Management Centre or to any CEN member. This European

8、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-CENELEC Management Centre has the same status as the official versions. CEN members are the

9、 national standards bodies of 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, Sw

10、itzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. N

11、o. EN ISO 13079:2011: EBS EN ISO 13079:2011EN ISO 13079:2011 (E) 3 Foreword 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.

12、 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

13、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

14、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

15、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. BS EN ISO 13079:2011ISO 13079:2011(E) ISO 2011 All rights reserved iiiContents Page Foreword iv 1 Scope1 2 Normative references1 3 Material .1 3.1 G

16、eneral .1 3.2 Glass.1 3.3 Plastics .2 4 Single-use Westergren tubes.2 4.1 General design.2 4.2 Straightness.2 4.3 Finish 2 4.4 Dimensions 2 4.5 Graduation and figuring3 4.6 Inscriptions 3 4.7 Labelling.3 5 Re-usable Westergren tubes3 5.1 General design.3 5.2 Straightness.4 5.3 Finish 4 5.4 Dimension

17、s 4 5.5 Graduation and figuring4 5.6 Inscriptions 4 5.7 Labelling.4 6 Support for Westergren tubes .5 6.1 Construction 5 6.2 Graduation and figuring6 6.3 Inscriptions 6 7 Graduation and figuring6 7.1 Graduation .6 7.2 Figuring of graduation lines.7 8 Marking.7 9 Labelling.7 9.1 Single-use Westergren

18、 tubes.7 9.2 Re-usable Westergren tubes7 Annex A (normative) Type test for rigidity of Westergren tubes .9 Annex B (normative) Type test for contamination and interfering substances .10 Annex C (normative) Type test for straightness of Westergren tubes11 Annex D (informative) Measurement of the eryt

19、hrocyte sedimentation rate by the Westergren reference method 13 Bibliography15 BS EN ISO 13079:2011ISO 13079:2011(E) iv ISO 2011 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work

20、of preparing 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-government

21、al, in liaison 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 mai

22、n task of technical 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. Att

23、ention is drawn 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 13079 was prepared by Technical Committee ISO/TC 48, Laboratory equipment, Subcommittee SC 6, Glass

24、and plastics ware including volumetric instruments. BS EN ISO 13079:2011INTERNATIONAL STANDARD ISO 13079:2011(E) ISO 2011 All rights reserved 1Laboratory glass and plastics ware Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method 1 Scope This International Standa

25、rd specifies requirements for single-use and re-usable glass and plastics 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 “We

26、stergren pipettes”. A procedure for measuring the erythrocyte sedimentation 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 ap

27、ply. It also does not apply for devices where the Westergren method 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 docu

28、ment. For dated references, only the edition cited applies. For undated 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

29、 tubes shall be made from rigid, transparent plastics or from glass 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 We

30、stergren tubes; b) the transparency shall be sufficient to permit 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

31、of the red cell layer. 3.2 Glass The manufacturer of the glass tubes should ensure that the glass tubes are as free as possible from visible defects and reasonably free from internal stress. BS EN ISO 13079:2011ISO 13079:2011(E) 2 ISO 2011 All rights reserved3.3 Plastics 3.3.1 The material of which

32、plastics tubes are made shall not affect the ESR value, when tested in accordance with 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 releas

33、e plasticizers that might alter sedimentation; c) if a mould-release agent is used in 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 w

34、ith the results when glass reference tubes are used. 4 Single-use Westergren tubes 4.1 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 Fi

35、nish 4.3.1 The glass tube shall be cut square (within 10) with the axis of the tube, 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

36、 10) with the axis of the tube. The ends should be smooth and may be slightly bevelled. 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 acc

37、ordance with the method described in Annex B. 4.3.4 The tube, by itself or in association 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

38、The measuring part of the tube shall conform to the dimensions given in Table 1. Table 1 Essential dimensions of single-use Westergren tubes Dimensions in millimetres Internal diameter 2,55 0,15 Length of measuring part 200 2 BS EN ISO 13079:2011ISO 13079:2011(E) ISO 2011 All rights reserved 34.5 Gr

39、aduation and figuring Graduation or figuring shall be in accordance with Clause 7. 4.6 Inscriptions Inscriptions 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

40、 tube with scale on support Figure 1 Single-use Westergren tubes 5 Re-usable Westergren tubes 5.1 General design The general design of a re-usable Westergren tube shall be as shown in Figure 2. BS EN ISO 13079:2011ISO 13079:2011(E) 4 ISO 2011 All rights reserved5.2 Straightness The tube shall be str

41、aight 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 ground 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 tapere

42、d as shown in Figure 2; the tapered portion shall be cut square with the axis of the tube and shall be finely ground, polished 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 cal

43、endered, they may slightly narrow. 5.4 Dimensions The tube shall conform to the dimensions given in Table 2. Table 2 Dimensions 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 Len

44、gth of tapering portion 6 2 Wall thickness of orifice at least 0,5 5.5 Graduation and figuring Graduation and figuring shall 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 Westergr

45、en tube shall be in accordance with Clause 8. Additionally, the inscription “re-usable Westergren ESR tube” may be inscribed. 5.7 Labelling Inscriptions on the packaging shall be in accordance with 9.2. BS EN ISO 13079:2011ISO 13079:2011(E) ISO 2011 All rights reserved 5Dimensions in millimetres Key

46、 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 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 rigid

47、ly 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 adjustable. NOTE The adjustable feet and an optional plumb-line or spirit-level permit adjustment that the tubes are held in vertical position. Vibration-free p

48、ositioning of the support enables correct measurements. 6.1.2 When erythrocyte sedimentation rates are to be measured against scales marked on 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 suppl

49、ied 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 to withstand repeated disinfection in the laboratory. BS EN ISO 13079:2011ISO 13079:2011(E) 6 ISO 2011 All rights reserved6.2 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 use with an appropriate support forming a system. The d