SIST EN ISO 8655-7:2022
(Main)Piston-operated volumetric apparatus - Part 7: Alternative measurement procedures for the determination of volume (ISO 8655-7:2022)
Piston-operated volumetric apparatus - Part 7: Alternative measurement procedures for the determination of volume (ISO 8655-7:2022)
This document specifies alternative measurement procedures for the determination of volume of
piston-operated volumetric apparatus.
The procedures are applicable to complete systems comprising the basic apparatus and all parts
selected for use with the apparatus, disposable or reusable, involved in the measurement by delivery
process (Ex). Methods described in this document are suitable for various maximum nominal volumes
of piston-operated volumetric apparatus. It is the responsibility of the user to select the appropriate
method.
Volumenmessgeräte mit Hubkolben - Teil 7: Alternatives Prüfverfahren zur Bestimmung des Volumens (ISO 8655-7:2022)
Dieser Teil von ISO 8655 legt alternative Referenzmessverfahren zur Bestimmung des Volumens von Volumenmessgeräten mit HubkolbenN1) fest.
Die Prüfungen gelten für vollständige Gerätesysteme, bestehend aus dem Grundgerät und allen für die Verwendung ausgewählten Zubehörteilen, die mehrfach verwendbar oder für den einmaligen Gebrauch bestimmt sein können; die Dosierung erfolgt durch Abgabevorgänge (Ex). Die in diesem Teil von ISO 8655 beschriebenen Verfahren eignen sich für unterschiedliche Höchstnennvolumina von Kolbenhubgeräten. Die Anwender dieser Norm müssen sicherstellen, dass das gewählte Verfahren seinem Verwendungszweck entspricht.
ANMERKUNG Allgemeine Anforderungen und Begriffsdefinitionen für Kolbenhubgeräte sind in ISO 8655-1 festgelegt. Hinsichtlich der messtechnischen Anforderungen, der Fehlergrenzen sowie der Anforderungen an Kennzeichnung und Nutzerinformation siehe ISO 8655-2 für Pipetten, ISO 8655-3 für Büretten, ISO 8655-4 für Dilutoren, ISO 8655-5 für Dispenser und ISO 8655-9 für manuell betätigte Präzisionslaborspritzen. Das gravimetrische Referenzmessverfahren für die Volumenbestimmung ist in ISO 8655-6 angegeben. Das photometrische Referenzmessverfahren für die Volumenbestimmung ist in ISO 8655-8 angegeben.
Appareils volumétriques à piston - Partie 7: Modes opératoires de mesure alternatifs pour la détermination de volumes (ISO 8655-7:2022)
Le présent document spécifie des modes opératoires de mesure alternatifs pour la détermination du volume des appareils volumétriques à piston.
Les modes opératoires sont applicables à des systèmes complets comprenant l’appareil de base et toutes les parties sélectionnées pour être utilisées avec l’appareil, à usage unique ou réutilisables, impliqués dans le mesurage par procédé de distribution (Ex). Les méthodes décrites dans le présent document sont adaptées à différents volumes nominaux maximum d’appareils volumétriques à piston. Il en va de la responsabilité de l’utilisateur de sélectionner la méthode appropriée.
Volumetrične naprave, delujoče na bat - 7. del: Nadomestni merilni postopki za določanje prostornine (ISO 8655-7:2022)
Ta dokument določa nadomestne merilne postopke za določanje prostornine volumetrične naprave, delujoče na bat. Postopki se uporabljajo za celotne sisteme, ki jih sestavljajo osnovna naprava in vsi deli, izbrani za uporabo skupaj z napravo, namenjeni enkratni ali večkratni uporabi, ki se uporabljajo pri merjenju z dovajanjem (Ex). Metode, opisane v tem dokumentu, so primerne za različne največje nazivne prostornine volumetričnih naprav, delujočih na bat. Za izbiro ustrezne metode je odgovoren uporabnik.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8655-7:2022
01-julij-2022
Nadomešča:
SIST EN ISO 8655-7:2006
SIST EN ISO 8655-7:2006/AC:2009
Volumetrične naprave, delujoče na bat - 7. del: Nadomestni merilni postopki za
določanje prostornine (ISO 8655-7:2022)
Piston-operated volumetric apparatus - Part 7: Alternative measurement procedures for
the determination of volume (ISO 8655-7:2022)
Volumenmessgeräte mit Hubkolben - Teil 7: Alternatives Prüfverfahren zur Bestimmung
des Volumens (ISO 8655-7:2022)
Appareils volumétriques à piston - Partie 7: Modes opératoires de mesure alternatifs
pour la détermination de volumes (ISO 8655-7:2022)
Ta slovenski standard je istoveten z: EN ISO 8655-7:2022
ICS:
17.060 Merjenje prostornine, mase, Measurement of volume,
gostote, viskoznosti mass, density, viscosity
71.040.20 Laboratorijska posoda in Laboratory ware and related
aparati apparatus
SIST EN ISO 8655-7:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8655-7:2022
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SIST EN ISO 8655-7:2022
EN ISO 8655-7
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 17.060 Supersedes EN ISO 8655-7:2005, EN ISO 8655-
7:2005/AC:2009
English Version
Piston-operated volumetric apparatus - Part 7: Alternative
measurement procedures for the determination of volume
(ISO 8655-7:2022)
Appareils volumétriques à piston - Partie 7: Modes Volumenmessgeräte mit Hubkolben - Teil 7:
opératoires de mesure alternatifs pour la Alternatives Prüfverfahren zur Bestimmung des
détermination de volumes (ISO 8655-7:2022) Volumens (ISO 8655-7:2022)
This European Standard was approved by CEN on 13 February 2022.
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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8655-7:2022 E
worldwide for CEN national Members.
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SIST EN ISO 8655-7:2022
EN ISO 8655-7:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 8655-7:2022
EN ISO 8655-7:2022 (E)
European foreword
This document (EN ISO 8655-7:2022) 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 November 2022, and conflicting national standards
shall be withdrawn at the latest by November 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8655-7:2005, EN ISO 8655-7:2005/AC:2009.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 8655-7:2022 has been approved by CEN as EN ISO 8655-7:2022 without any
modification.
3
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SIST EN ISO 8655-7:2022
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SIST EN ISO 8655-7:2022
INTERNATIONAL ISO
STANDARD 8655-7
Second edition
2022-04
Piston-operated volumetric
apparatus —
Part 7:
Alternative measurement procedures
for the determination of volume
Appareils volumétriques à piston —
Partie 7: Modes opératoires de mesure alternatifs pour la
détermination de volumes
Reference number
ISO 8655-7:2022(E)
© ISO 2022
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SIST EN ISO 8655-7:2022
ISO 8655-7:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2022 – All rights reserved
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SIST EN ISO 8655-7:2022
ISO 8655-7:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 2
4.1 Metrological confirmation . 2
4.2 Uncertainty of measurement . 2
4.3 Operator qualification . 2
5 Performance requirements . .3
5.1 Performance tolerances . 3
5.2 Operator impact . 3
6 Test conditions .3
6.1 General . 3
6.2 Test equipment . 3
6.3 Test room, environmental conditions . 3
6.4 Test volumes . 4
6.4.1 Fixed volume POVA. 4
6.4.2 Adjustable volume POVA . 4
6.5 Number of measurements per test volume . 4
6.6 Test liquids . 5
7 Evaluation . 5
7.1 Mean volume . 5
7.2 Systematic error of measurement . 5
7.3 Random error of measurement . 6
8 Test methods . 6
8.1 General . 6
8.2 Gravimetric method . . 7
8.3 Dual-dye ratiometric photometric method . 7
8.4 Single dye photometric method . 8
8.5 Hybrid photometric/gravimetric method for multichannel POVA . 8
8.6 Titration method . 8
8.7 Batch testing . 8
9 Dispense procedures .8
9.1 General . 8
9.2 Preparation . 9
9.3 Single-channel air displacement pipettes (in accordance with ISO 8655-2) . 9
9.3.1 General . 9
9.3.2 Test cycle . 9
9.4 Multi-channel pipettes (in accordance with ISO 8655-2) . 10
9.5 Positive displacement pipettes (in accordance with ISO 8655-2) . 11
9.6 Burettes (in accordance with ISO 8655-3) . 11
9.7 Dilutors (in accordance with ISO 8655-4) .12
9.7.1 General .12
9.7.2 Test cycle . 12
9.8 Dispensers (in accordance with ISO 8655-5) . 13
9.9 Syringes (in accordance with ISO 8655-9) . 13
9.9.1 General .13
9.9.2 Test cycle .13
10 Reporting of results .14
iii
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SIST EN ISO 8655-7:2022
ISO 8655-7:2022(E)
Annex A (normative) Gravimetric procedure .16
Annex B (normative) Dual-dye ratiometric photometric procedure .21
Annex C (normative) Single dye photometric procedure .29
Annex D (normative) Photometric/gravimetric hybrid procedure .33
Annex E (normative) Titrimetric procedure.41
Annex F (normative) Conversion of liquid mass to volume .45
Bibliography .48
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SIST EN ISO 8655-7:2022
ISO 8655-7:2022(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 48, Laboratory equipment, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 332, Laboratory
equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
This second edition cancels and replaces the first edition (ISO 8655-7:2005), which has been technically
revised. It also incorporates the Technical Corrigendum ISO 8655-7:2005/Cor.1:2008.
The main changes are as follows:
— a gravimetric test method was added (see 8.2);
— a photometric/gravimetric hybrid test method was added (see 8.5);
— a batch testing method was added (see 8.7);
— measurement procedures for all methods are given in normative Annexes A to E;
— standard dispense procedures for POVA described in ISO 8655-2, ISO 8655−3, ISO 8655−4,
ISO 8655−5, and ISO 8655−9 were added (see Clause 9);
— requirements for operator qualification have been added (see 4.3);
— requirements for testing of multi-channel POVA is described in more detail, with specific procedures
given for these apparatus (see 8.5, and Annex D);
— Annexes A, B, and C of the first edition have been deleted and replaced.
A list of all parts in the ISO 8655 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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SIST EN ISO 8655-7:2022
ISO 8655-7:2022(E)
Introduction
The ISO 8655 series addresses the needs of:
— manufacturers, as a basis for quality control including, where appropriate, the issuance of
manufacturer’s declarations;
— calibration laboratories, test houses, users of the equipment and other bodies as a basis for
independent calibration, testing, verification, and routine tests.
The tests specified in the ISO 8655 series are intended to be carried out by trained personnel.
vi
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SIST EN ISO 8655-7:2022
INTERNATIONAL STANDARD ISO 8655-7:2022(E)
Piston-operated volumetric apparatus —
Part 7:
Alternative measurement procedures for the
determination of volume
1 Scope
This document specifies alternative measurement procedures for the determination of volume of
piston-operated volumetric apparatus.
The procedures are applicable to complete systems comprising the basic apparatus and all parts
selected for use with the apparatus, disposable or reusable, involved in the measurement by delivery
process (Ex). Methods described in this document are suitable for various maximum nominal volumes
of piston-operated volumetric apparatus. It is the responsibility of the user to select the appropriate
method.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 1042, Laboratory glassware — One-mark volumetric flasks
ISO 2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 3951-1, Sampling procedures for inspection by variables — Part 1: Specification for single sampling
plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic
and a single AQL
ISO 8655-1, Piston-operated volumetric apparatus — Part 1: Terminology, general requirements and user
recommendations
ISO 8655-2, Piston-operated volumetric apparatus — Part 2: Pipettes
ISO 8655-3, Piston-operated volumetric apparatus — Part 3: Burettes
ISO 8655-4, Piston-operated volumetric apparatus — Part 4: Dilutors
ISO 8655-5, Piston-operated volumetric apparatus — Part 5: Dispensers
ISO 8655-6, Piston-operated volumetric apparatus — Part 6: Gravimetric reference measurement
procedure for the determination of volume
ISO 8655-8, Piston-operated volumetric apparatus — Part 8: Photometric reference measurement
procedure for the determination of volume
ISO 8655-9, Piston-operated volumetric apparatus — Part 9: Manually operated precision laboratory
syringes
ISO/IEC Guide 2, Standardization and related activities — General vocabulary
1
© ISO 2022 – All rights reserved
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SIST EN ISO 8655-7:2022
ISO 8655-7:2022(E)
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated
terms (VIM)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 8655-1, ISO/IEC Guide 2,
ISO/IEC Guide 99 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
acceptance quality limit
AQL
worst tolerable quality level
Note 1 to entry: This concept only applies when a sampling scheme with rules for switching and for
discontinuation, such as in ISO 2859-1, ISO 3951-1 or ISO 3951-5 is used.
Note 2 to entry: Although individual lots with quality as bad as the acceptance quality limit may be accepted
with fairly high probability, the designation of an acceptance quality limit does not suggest that this is a desirable
quality level. Sampling schemes found in International Standards such as ISO 2859-1, ISO 3951-1 or ISO 3951-5,
with their rules for switching and for discontinuation of sampling inspection, are designed to encourage suppliers
to have process averages consistently better than the AQL.
4 General requirements
4.1 Metrological confirmation
Metrological confirmation of all POVA shall be performed on a regular basis to ensure the apparatus
conforms to requirements for its intended use. The requirements of the methods and procedures
described in this document are suitable to be used in the metrological confirmation of POVA. For
calibrations and testing, no less than ten replicate measurements per selected volume shall be
performed and the measurement procedures in this document shall be validated by comparison to one
of the reference measurement procedures described in ISO 8655-6 or ISO 8655-8.
4.2 Uncertainty of measurement
When performing calibrations (ISO 8655-1:2022, 6.4) according to measurement procedures described
in this document, the expanded measurement uncertainty of the mean delivered volume for each
selected volume shall be estimated and reported (see Clause 10 (m)).
When performing testing (ISO 8655-1:2022, 6.4) or routine tests (ISO 8655-1:2022, 6.5), it is optional to
estimate and report the expanded measurement uncertainty.
NOTE For further information on uncertainty for the photometric and gravimetric methods, refer to
[1] [2]
ISO/TR 16153 and ISO/TR 20461 respectively.
4.3 Operator qualification
An operator who uses POVA for volumetric transfers, performs metrological confirmation or routine
tests of POVA shall be adequately trained on the use of the type of POVA under test. Operator training
and competence should be documented.
NOTE 1 Previously calibrated POVA can be used for the qualification of operators.
2
© ISO 2022 – All rights reserved
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SIST EN ISO 8655-7:2022
ISO 8655-7:2022(E)
NOTE 2 Training and qualification requirements for operators of POVA are intended to be included in
ISO 8655-10.
5 Performance requirements
5.1 Performance tolerances
Calibration, testing, and routine test results may be reported without comparison to performance
tolerances. If the results are verified against performance tolerances, these tolerances shall be stated
on the test report/certificate.
Performance tolerances may be based on the user’s liquid handling process tolerances or the product
tolerances given in the part of ISO 8655 corresponding to the type of POVA under test or the tolerances
specified by the manufacturer, subject to them being fit for purpose.
5.2 Operator impact
Measurement of volumetric performance includes random and systematic errors of the POVA, as well as
errors introduced by the device’s operator. The performance of a hand-held pipette is inseparable from
the performance of its operator.
NOTE More information about operator impact is given in ISO 8655-10.
6 Test conditions
6.1 General
Test conditions described in this clause shall be validated for their suitability for the selected test
method and procedure. Test conditions, together with the test equipment and detailed test procedure,
impact the uncertainty of measurement. Examples for the calculation of the expanded uncertainty of
[1]
the mean volume and of the uncertainty in use of a single delivered volume are given in ISO/TR 16153
[2]
and ISO/TR 20461 .
6.2 Test equipment
All equipment used for the testing of POVA, including for the preparation of test solutions, shall be
chosen such that the required uncertainty of measurement can be obtained.
All test equipment used shall be of suitable readability, accuracy, reproducibility and stability, consistent
with the required expanded uncertainty of measurement.
Deviations from the test equipment given in this document shall be taken into account when calculating
the expanded measurement uncertainty and shall be proven to yield measurement results fit for the
intended purpose.
6.3 Test room, environmental conditions
The following applies:
a) The test room should be kept at a steady temperature throughout the entirety of the equilibration
time for the test equipment and POVA (±1 °C), and throughout the POVA testing time (±0,5 °C). All
test equipment, POVA, exchangeable parts (e. g. pipette tips), and reagents used shall be equilibrated
to the test room temperature.
b) The air temperature, relative humidity, and barometric pressure at the time of the test shall be
recorded. At the start and at the end of the n replic
...
SLOVENSKI STANDARD
oSIST prEN ISO 8655-7:2020
01-oktober-2020
Volumetrične naprave, delujoče na bat - 7. del: Nadomestni merilni postopki za
določanje prostornine (ISO/DIS 8655-7:2020)
Piston-operated volumetric apparatus - Part 7: Alternative measurement procedures for
the determination of volume (ISO/DIS 8655-7:2020)
Volumenmessgeräte mit Hubkolben - Teil 7: Alternatives Prüfverfahren zur Bestimmung
des Volumens (ISO/DIS 8655-7:2020)
Appareils volumétriques à piston - Partie 7: Méthodes non gravimétriques pour
l’estimation de la performance d’équipement (ISO/DIS 8655-7:2020)
Ta slovenski standard je istoveten z: prEN ISO 8655-7
ICS:
17.060 Merjenje prostornine, mase, Measurement of volume,
gostote, viskoznosti mass, density, viscosity
71.040.20 Laboratorijska posoda in Laboratory ware and related
aparati apparatus
oSIST prEN ISO 8655-7:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 8655-7:2020
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oSIST prEN ISO 8655-7:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8655-7
ISO/TC 48 Secretariat: DIN
Voting begins on: Voting terminates on:
2020-07-29 2020-10-21
Piston-operated volumetric apparatus —
Part 7:
Alternative measurement procedures for the
determination of volume
ICS: 17.060
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 8655-7:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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oSIST prEN ISO 8655-7:2020
ISO/DIS 8655-7:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST prEN ISO 8655-7:2020
ISO/DIS 8655-7:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 2
4.1 Metrological confirmation . 2
4.2 Operator qualification. 2
5 Requirements for testing multi-channel POVA . 3
6 Performance requirements . 3
6.1 Performance tolerances . 3
6.2 Operator impact . 3
7 Test conditions . 3
7.1 General . 3
7.2 Test equipment . 3
7.3 Test room, environmental conditions . 4
7.4 Test volumes . 4
7.4.1 Fixed volume POVA . 4
7.4.2 Adjustable volume POVA . 4
7.5 Number of measurements per test volume . 4
7.6 Test liquids. 5
8 Evaluation . 5
8.1 Mean volume. 5
8.2 Systematic error . 5
8.3 Random error . 6
9 Test methods . 6
9.1 General . 6
9.2 Gravimetric method . 7
9.3 Dual-dye ratiometric photometric method . 7
9.4 Single dye photometric method . 7
9.5 Hybrid photometric/gravimetric method for multichannel POVA . 7
9.6 Titration method . 8
9.7 Batch testing . 8
10 Dispense procedures . 8
10.1 General . 8
10.2 Preparation . 8
10.3 Single-channel air displacement pipettes (in accordance with ISO 8655-2) . 9
10.3.1 General. 9
10.3.2 Test cycle . 9
10.4 Multi-channel pipettes (in accordance with ISO 8655-2) .10
10.5 Positive displacement pipettes (in accordance with ISO 8655-2) .10
10.6 Burettes (in accordance with ISO 8655-3) .11
10.7 Dilutors (in accordance with ISO 8655-4) .11
10.7.1 General.11
10.7.2 Test cycle .12
10.8 Dispensers (in accordance with ISO 8655-5) .12
10.9 Syringes (in accordance with ISO 8655-9) .13
10.9.1 General.13
10.9.2 Test cycle .13
11 Reporting of results .13
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Annex A (normative) Gravimetric procedure .15
Annex B (normative) Dual-dye ratiometric photometric procedure .20
Annex C (normative) Single dye photometric procedure .27
Annex D (normative) Photometric/gravimetric hybrid procedure .31
Annex E (normative) Titrimetric procedure .40
Annex F (normative) Conversion of liquid mass to volume .44
Bibliography .47
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oSIST prEN ISO 8655-7:2020
ISO/DIS 8655-7:2020(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 48, Laboratory Equipment, Working
Group WG 04, Piston-operated instruments.
This second edition cancels and replaces the first edition (ISO 8655-7:2005 and ISO 8655-7:2005/Cor
1:2008), which has been technically revised.
The main changes compared to the previous edition are as follows:
— a gravimetric test method was added (Clause 9.2);
— a photometric/gravimetric hybrid test method was added (Clause 9.5);
— a batch testing method was added (Clause 9.7);
— measurement procedures for all methods are given in normative Annexes A to E;
— standard dispense procedures for POVA described in ISO 8655-2, −3, −4, −5, and −9 were added
(Clause 10);
— requirements for operator qualification have been added (Clause 4.2);
— requirements for testing of multi-channel POVA is described in more detail, with specific procedures
given for these apparatus (Clauses 5, 9.5, and Annex D);
— Annexes A, B, and C of the first edition have been deleted and replaced.
A list of all parts in the ISO 8655 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
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oSIST prEN ISO 8655-7:2020
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Introduction
ISO 8655 addresses the needs of:
— manufacturers, as a basis for quality control including, where appropriate, the issuance of
manufacturer’s declarations;
— calibration laboratories, test houses, users of the equipment and other bodies as a basis for
independent calibration, certification, and routine checking.
The tests specified in the ISO 8655 series are intended to be carried out by trained personnel.
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oSIST prEN ISO 8655-7:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 8655-7:2020(E)
Piston-operated volumetric apparatus —
Part 7:
Alternative measurement procedures for the
determination of volume
1 Scope
This part of ISO 8655 specifies alternative measurement procedures for the determination of volume of
piston-operated volumetric apparatus.
The tests are applicable to complete systems comprising the basic apparatus and all parts selected
for use with the apparatus, disposable or reusable, involved in the measurement by delivery process
(Ex). Methods described in this part of ISO 8655 are suitable for various maximum nominal volumes of
piston-operated volumetric apparatus. The user of this standard shall ensure that the selected method
is suitable for its intended purpose.
NOTE General requirements and definitions of terms for piston-operated volumetric apparatus are given
in ISO 8655-1. For the metrological requirements, maximum permissible errors, requirements for marking and
information to be provided for users for piston-operated volumetric apparatus, see ISO 8655-2 for pipettes,
see ISO 8655-3 for burettes, see ISO 8655-4 for dilutors, see ISO 8655-5 for dispensers, and see ISO 8655-9 for
manually operated precision laboratory syringes. The gravimetric reference measurement procedure for the
determination of volume is given in ISO 8655-6. The photometric reference measurement procedure for the
determination of volume is given in ISO 8655-8.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO/DIS 8655-1:2020, Piston-operated volumetric apparatus — Part 1: Terminology, general requirements
and user recommendations
ISO/DIS 8655-2, 2022, Piston-operated volumetric apparatus — Part 2: Piston pipettes
ISO/DIS 8655-3:2020, Piston-operated volumetric apparatus — Part 3: Piston burettes
ISO/DIS 8655-4:2020, Piston-operated volumetric apparatus — Part 4: Dilutors
ISO/DIS 8655-5:2020, Piston-operated volumetric apparatus — Part 5: Dispensers
ISO/DIS 8655-6:2020, Piston-operated volumetric apparatus — Part 6: Gravimetric reference measurement
procedure for the determination of volume
ISO/DIS 8655-8:2020, Piston-operated volumetric apparatus — Part 8: Photometric reference
measurement procedure for the determination of volume
ISO/DIS 8655-9:2020, Piston-operated volumetric apparatus — Part 9: Manually operated precision
laboratory syringes
ISO/TR 16153, Piston-operated volumetric instruments — Determination of uncertainty for volume
measurements made using the photometric method
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oSIST prEN ISO 8655-7:2020
ISO/DIS 8655-7:2020(E)
ISO/TR 20461, Determination of uncertainty for volume measurements made using the gravimetric method
ISO/IEC Guide 2, Standardization and related activities — General vocabulary
ISO/IEC Guide 98-3:2008, Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in
me a s ur ement (GUM: 1995)
ISO/IEC Guide 98-4:2012, Uncertainty of measurement — Part 4: Role of measurement uncertainty in
conformity assessment
ISO/IEC Guide 99:2007, International vocabulary of metrology — Basic and general concepts and
associated terms (VIM)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/DIS 8655-1:2020,
ISO/IEC Guide 2, and ISO/IEC Guide 99 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at https:// www .iso .org/ obp
3.1
acceptance quality limit
AQL
worst tolerable quality level
Note 1 to entry: This concept only applies when a sampling scheme with rules for switching and for
discontinuation, such as in ISO 2859-1, ISO 3951-1 or ISO 3951-5 is used.
Note 2 to entry: Although individual lots with quality as bad as the acceptance quality limit may be accepted
with fairly high probability, the designation of an acceptance quality limit does not suggest that this is a desirable
quality level. Sampling schemes found in International Standards such as ISO 2859-1, ISO 3951-1 or ISO 3951-5,
with their rules for switching and for discontinuation of sampling inspection, are designed to encourage suppliers
to have process averages consistently better than the AQL.
[SOURCE: ISO 3951-5:2006, 3.6 – modified: shortened Note 2 to entry.]
4 General requirements
4.1 Metrological confirmation
Metrological confirmation of all POVA shall be performed on a regular basis to ensure the apparatus
conforms to requirements for its intended use. The requirements of the methods and procedures
described in this International Standard are suitable to be used for metrological confirmation of POVA.
For calibrations, the procedure of this International Standard shall be validated by comparison to one
of the reference measurement procedures described in ISO 8655-6 or ISO 8655-8.
4.2 Operator qualification
An operator who uses, calibrates, or tests POVA shall be adequately trained on the use of the type of
POVA under test. Operator training and competence should be documented.
NOTE It is worth considering the qualification of operators with previously calibrated pipettes.
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ISO/DIS 8655-7:2020(E)
5 Requirements for testing multi-channel POVA
Metrological confirmation of multi-channel POVA shall test the performance of each channel of a multi-
channel POVA by calibration and routine tests on a regular basis. Not testing each channel can leave the
user exposed to significant risk of error.
Test liquid should be aspirated simultaneously with all channels of a multi-channel POVA, as described
in ISO 8655-2. If liquid is aspirated in one channel only, this fact shall be reported within the test report.
Depending on the selected test method and available measurement equipment, it might be necessary to
test each channel individually in successive tests.
NOTE 1 Using a test method based on volume measurements in a microplate allows for simultaneous
dispensing of the test liquid from all channels into the microplate. Annex D provides a procedure for calibrating
multi-channel pipettes.
NOTE 2 Consistent and even tip fitting is important and can impact performance.
NOTE 3 Channel to channel variation can be exaggerated by poor quality tips. Differences in dimensions will
lead to inconsistent aspiration and delivery.
6 Performance requirements
6.1 Performance tolerances
Calibration and routine test results may be reported without comparison to performance tolerances.
If the results are verified against performance tolerances, these tolerances shall be agreed upon with
the user.
Performance tolerances may be based on the user’s liquid handling process tolerances or the
product tolerances given in the part of ISO 8655 corresponding to the type of POVA under test or the
manufacturers tolerances, subject to them being fit for purpose.
6.2 Operator impact
Measurement of volumetric performance includes random and systematic errors of the POVA, as well as
errors introduced by the device’s operator. Performance tolerances for POVA shall include the operator
error component as well, where applicable.
NOTE The performance of a hand-held pipette is inseparable from the performance of its operator.
7 Test conditions
7.1 General
Test conditions described in this clause shall be validated for their suitability for the selected test
method and procedure. Test conditions, together with the test equipment and detailed test procedure,
impact the uncertainty of measurement. Examples for the calculation of the expanded uncertainty of
the mean volume and of the uncertainty in use of a single delivered volume are given in ISO/TR 16153
and ISO/TR 20461.
7.2 Test equipment
All equipment used for the testing of POVA, including for the preparation of test solutions, shall be
chosen such that the required uncertainty of measurement can be obtained.
All test equipment used shall be of suitable readability, accuracy, reproducibility and stability, consistent
with the required expanded uncertainty of measurement.
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ISO/DIS 8655-7:2020(E)
Deviations from the test equipment given in this standard shall be taken into account when calculating
the expanded measurement uncertainty and shall be proven to yield measurement results fit for the
intended purpose.
7.3 Test room, environmental conditions
The test room should be kept at a steady temperature throughout the entirety of the equilibration time
for the test equipment and POVA (± 1 °C), and throughout the POVA testing time (± 0,5 °C). All test
equipment, POVA, exchangeable parts (e.g. pipette tips), and reagents used shall be equilibrated to the
test room temperature.
The ambient temperature, relative humidity, and barometric pressure at the time of the test shall be
recorded.
To evaluate a POVA’s fitness for purpose, the test room conditions should reflect the environmental
conditions under which the POVA is used. This can generally be achieved when a POVA is calibrated
within the laboratory in which it is used.
NOTE Calibration laboratories at test houses or pipette manufacturer’s quality control laboratories can often
precisely control environmental conditions to achieve a desired standard condition. It can be very challenging to
reproduce such results under different environmental conditions.
7.4 Test volumes
7.4.1 Fixed volume POVA
In the case of a fixed-volume POVA, the selected volume V is the nominal volume V and is the only
S 0
test volume.
7.4.2 Adjustable volume POVA
a) For calibrations, adjustable volume POVA shall be tested at least at three volumes:
— nominal volume,
— 50 % of the nominal volume, or the closest possible (if equidistant, use the higher value);
— the lower limit of the useable volume range or 10 % of the nominal volume (whichever is the
greater).
Measurement of further volumes is optional.
b) For routine tests, fewer than three volumes may be tested.
In case the POVA is to be tested at only two volumes, the nominal volume and the lower limit of the
useable volume range, or 10% of the nominal volume (whichever is the greater), shall be tested.
NOTE The linearity of delivered volumes between these two test points is unknown and leaves the user with
increased risk for volumetric errors as compared to a test at three volumes.
In case the POVA is tested only at one volume, it shall be tested at its nominal volume, or at the volume
at which it will be used.
7.5 Number of measurements per test volume
The confidence of metrological confirmation increases with the number of replicate measurements
for each test volume. A minimum of ten measurements per volume are required by the reference
measurement procedures of ISO 8655-6 and ISO 8655-8. For the test procedures of this International
Standard, ten measurements are encouraged, but fewer replicate measurements may be made if the
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expanded uncertainty of measurement for the POVA is fit for the intended pu
...
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