SIST EN ISO 13079:2011
(Main)Laboratory glass and plastics ware - Tubes and support for the measurement of erythrocytic sedimentation rate by the Westergren method (ISO 13079:2011)
Laboratory glass and plastics ware - Tubes and support for the measurement of erythrocytic sedimentation rate by the Westergren method (ISO 13079:2011)
This International Standard 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 “Westergren 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 apply. 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.
Laborgeräte aus Glas und Kunststoff - Westergren-Rohre und Ständer für die Erythrozyten-Sedimentationsgeschwindigkeit (ISO 13079:2011)
Diese Internationale Norm legt Anforderungen an einmalig und mehrmalig verwendbare Glas- und
Kunstfoffrohre zur Messung der Erythrocyten-Sedimentationsgeschwindigkeit (en: erythrocyte sedimantation
rate (ESR)) nach dem Westergrenverfahren fest; des Weiteren ist ein Ständer zur Aufnahme der Rohre
während des Tests beschrieben. Diese sogenannten „Westergrenrohre“ werden manchmal auch als
„Westergrenpipetten“ bezeichnet. Ein Verfahren zur Messung der Erythrocyten-Sedimentationsgeschwindigkeit
nach Westergren ist in Anhang D angegeben.
Diese Norm gilt nicht für Gefäße zur venösen Blutabnahme beim Menschen und für deren Zubehör, für die
andere Normen gelten. Diese Norm gilt auch nicht für Geräte, bei denen das Westergrenverfahren als
Grundlage für die Entwicklung anderer, ähnlicher Verfahren oder Geräte für die Erythrocyten-Sedimentationsgeschwindigkeit
gedient hat.
Matériel de laboratoire en verre et en plastique - Tubes et support pour le mesurage de la vitesse de sédimentation des érythrocytes par la méthode Westergren (ISO 13079:2011)
L'ISO 13079:2011 spécifie les exigences relatives aux tubes en verre ou en plastique à usage unique ou réutilisables utilisés pour le mesurage de la vitesse de sédimentation des érythrocytes par la méthode de Westergren et les exigences relatives au support utilisé pour maintenir les tubes au cours de l'essai. Ces tubes dits «de Westergren» sont aussi parfois désignés sous l'appellation de «pipettes de Westergren». Un mode opératoire pour mesurer la vitesse de sédimentation des érythrocytes par la méthode de Westergren est donné en annexe informative.
L'ISO 13079:2011 ne s'applique pas aux récipients à usage unique utilisés pour le prélèvement d'échantillons de sang veineux humain ni à leurs accessoires, pour lesquels d'autres normes sont applicables. Elle ne s'applique pas non plus aux dispositifs où la méthode de Westergren a été utilisée comme base de développement d'autres méthodes ou matériels similaires pour la détermination de la vitesse de sédimentation des érythrocytes.
Laboratorijska steklena in plastična posoda - Epruvete in podpora za merjenje stopnje usedanja eritrocitov z Westergrenovo metodo (ISO 13079:2011)
Ta mednarodni standard določa zahteve za steklene in plastične posode za enkratno ali večkratno uporabo za merjenje stopnje usedanja eritrocitov (ESR) z Westergrenovo metodo, ter za podporo epruvet med izpeljavo preskusa. Te tako imenovane »Westergrenove epruvete« so včasih označene kot »Westergrenove pipete«. Postopek za merjenje stopnje usedanja eritrocitov z Westergrenovo metodo je podan v informativnem dodatku D. Ta mednarodni standard ne velja za posode za enkratno uporabo za zbiranje vzorcev človeške venske krvi ter njihov pribor, za katere veljajo drugi standardi. Prav tako ne velja za naprave, kjer je bila Westergrenova metoda uporabljena kot osnova za razvoj drugih podobnih metod ali opreme za določanje merjenja stopnje usedanja eritrocitov.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 13079:2011
01-oktober-2011
/DERUDWRULMVNDVWHNOHQDLQSODVWLþQDSRVRGD(SUXYHWHLQSRGSRUD]DPHUMHQMH
VWRSQMHXVHGDQMDHULWURFLWRY]:HVWHUJUHQRYRPHWRGR ,62
Laboratory glass and plastics ware - Tubes and support for the measurement of
erythrocytic sedimentation rate by the Westergren method (ISO 13079:2011)
Laborgeräte aus Glas und Kunststoff - Westergren-Rohre und Ständer für die
Erythrozyten-Sedimentationsgeschwindigkeit (ISO 13079:2011)
Matériel de laboratoire en verre et en plastique - Tubes et support pour le mesurage de
la vitesse de sédimentation des érythrocytes par la méthode Westergren (ISO
13079:2011)
Ta slovenski standard je istoveten z: EN ISO 13079:2011
ICS:
71.040.20 Laboratorijska posoda in Laboratory ware and related
aparati apparatus
SIST EN ISO 13079:2011 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 13079:2011
---------------------- Page: 2 ----------------------
SIST EN ISO 13079:2011
EUROPEAN STANDARD
EN ISO 13079
NORME EUROPÉENNE
EUROPÄISCHE NORM
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)
Matériel de laboratoire en verre et en plastique - Tubes Laborgeräte aus Glas und Kunststoff - Westergren-Rohre
pour le mesurage de la vitesse de sédimentation des für die Erythrozyten-Sedimentationsgeschwindigkeit (ISO
érythrocytes par la méthode Westergren (ISO 13079:2011) 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 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-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 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, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13079:2011: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 13079:2011
EN ISO 13079:2011 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 13079:2011
EN ISO 13079:2011 (E)
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.
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 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 implement 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, Switzerland 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
---------------------- Page: 5 ----------------------
SIST EN ISO 13079:2011
---------------------- Page: 6 ----------------------
SIST EN ISO 13079:2011
INTERNATIONAL ISO
STANDARD 13079
First edition
2011-07-15
Laboratory glass and plastics ware —
Tubes for the measurement of the
erythrocyte sedimentation rate by the
Westergren method
Matériel de laboratoire en verre et en plastique — Tubes pour le
mesurage de la vitesse de sédimentation des érythrocytes par la
méthode Westergren
Reference number
ISO 13079:2011(E)
©
ISO 2011
---------------------- Page: 7 ----------------------
SIST EN ISO 13079:2011
ISO 13079:2011(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2011 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 13079:2011
ISO 13079:2011(E)
Contents Page
Foreword .iv
1 Scope.1
2 Normative references.1
3 Material .1
3.1 General .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 figuring.3
4.6 Inscriptions .3
4.7 Labelling.3
5 Re-usable Westergren tubes.3
5.1 General design.3
5.2 Straightness.4
5.3 Finish .4
5.4 Dimensions .4
5.5 Graduation and figuring.4
5.6 Inscriptions .4
5.7 Labelling.4
6 Support for Westergren tubes .5
6.1 Construction .5
6.2 Graduation and figuring.6
6.3 Inscriptions .6
7 Graduation and figuring.6
7.1 Graduation .6
7.2 Figuring of graduation lines.7
8 Marking.7
9 Labelling.7
9.1 Single-use Westergren tubes.7
9.2 Re-usable Westergren tubes.7
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 tubes.11
Annex D (informative) Measurement of the erythrocyte sedimentation rate by the Westergren
reference method .13
Bibliography.15
© ISO 2011 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 13079:2011
ISO 13079:2011(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work 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-governmental, 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 main 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.
Attention 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 and plastics ware including volumetric instruments.
iv © ISO 2011 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 13079:2011
INTERNATIONAL STANDARD ISO 13079:2011(E)
Laboratory glass and plastics ware — Tubes for the
measurement of the erythrocyte sedimentation rate by the
Westergren method
1 Scope
This International Standard 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 “Westergren 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 apply. 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 document. 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 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 Westergren 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 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.
© ISO 2011 – All rights reserved 1
---------------------- Page: 11 ----------------------
SIST EN ISO 13079:2011
ISO 13079:2011(E)
3.3 Plastics
3.3.1 The material of which 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 release 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 with 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 Finish
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 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 accordance 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
de
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.