SIST EN ISO 8655-2:2022
(Main)Piston-operated volumetric apparatus - Part 2: Pipettes (ISO 8655-2:2022)
Piston-operated volumetric apparatus - Part 2: Pipettes (ISO 8655-2:2022)
This document specifies
— metrological requirements,
— maximum permissible errors,
— requirements for marking and
— information to be provided for users,
for air-displacement (type A) and positive displacement (type D) single-channel and multi-channel
pipettes, complete with their selected tip(s) and any other essential, consumable parts, designed to
deliver the selected volume (Ex).
Volumenmessgeräte mit Hubkolben - Teil 2: Pipetten (ISO 8655-2:2022)
Dieser Teil von ISO 8655 trifft Festlegungen hinsichtlich
- metrologischer Anforderungen,
- Fehlergrenzen,
- Anforderungen an die Kennzeichnung und
- Benutzerinformation
von Pipetten mit Luftpolster (Form A) und von Direktverdrängerpipetten (Form D); er gilt für Einkanal- und Mehrkanalpipetten, die auf das gewählte Volumen (Ex) justiert sind, vollständig mit ihren ausgewählten Pipettenspitzen und anderen wichtigen Verbrauchsteilen.
ANMERKUNG Allgemeine Anforderungen und Begriffsdefinitionen für Kolbenhubgeräte sind in ISO 8655-1 festgelegt. Das gravimetrische Referenzmessverfahren für die Volumenbestimmung ist in ISO 8655-6 angegeben. Das photometrische Referenzmessverfahren für die Volumenbestimmung ist in ISO 8655-8 angegeben. Alternative Verfahren für die Volumenbestimmung werden in ISO 8655-7 beschrieben. Für Sicherheitsanforderungen an elektrisch betriebene Pipetten siehe regionale oder nationale Sicherheitsnormen.
Appareils volumétriques à piston - Partie 2: Pipettes (ISO 8655-2:2022)
Le présent document spécifie:
— les exigences métrologiques;
— les erreurs maximales tolérées;
— les exigences relatives au marquage; et
— les informations à fournir aux utilisateurs;
pour les pipettes monocanal et multicanaux à déplacement d’air (type A) et à déplacement positif (type D), équipées de leur(s) cône(s) sélectionné(s) et de toutes les autres parties essentielles à usage unique, conçues pour distribuer le volume sélectionné (Ex).
Volumetrične naprave, delujoče na bat - 2. del: Pipete (ISO 8655-2:2022)
Ta dokument določa: – meroslovne zahteve; – največje dopustne pogreške; – zahteve za označevanje; in – informacije, predvidene za uporabnike, za enokanalne in večkanalne pipete z izpodrivom zraka (tip A) ter s prisilnim pretokom (tip D), opremljene z izbranimi konicami in drugimi bistvenimi, potrošnimi deli, ki so namenjeni dovajanju izbranega odmerka (Ex).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8655-2:2022
01-julij-2022
Nadomešča:
SIST EN ISO 8655-2:2002
SIST EN ISO 8655-2:2002/AC:2009
Volumetrične naprave, delujoče na bat - 2. del: Pipete (ISO 8655-2:2022)
Piston-operated volumetric apparatus - Part 2: Pipettes (ISO 8655-2:2022)
Volumenmessgeräte mit Hubkolben - Teil 2: Pipetten (ISO 8655-2:2022)
Appareils volumétriques à piston - Partie 2: Pipettes (ISO 8655-2:2022)
Ta slovenski standard je istoveten z: EN ISO 8655-2:2022
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 8655-2:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8655-2:2022
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SIST EN ISO 8655-2:2022
EN ISO 8655-2
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 17.060 Supersedes EN ISO 8655-2:2002, EN ISO 8655-
2:2002/AC:2009
English Version
Piston-operated volumetric apparatus - Part 2: Pipettes
(ISO 8655-2:2022)
Appareils volumétriques à piston - Partie 2: Pipettes Volumenmessgeräte mit Hubkolben - Teil 2: Pipetten
(ISO 8655-2:2022) (ISO 8655-2:2022)
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 8655-2:2022 E
worldwide for CEN national Members.
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SIST EN ISO 8655-2:2022
EN ISO 8655-2:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 8655-2:2022
EN ISO 8655-2:2022 (E)
European foreword
This document (EN ISO 8655-2:2022) 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 8655-2:2002.
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 8655-2:2022 has been approved by CEN as EN ISO 8655-2:2022 without any
modification.
3
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SIST EN ISO 8655-2:2022
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SIST EN ISO 8655-2:2022
INTERNATIONAL ISO
STANDARD 8655-2
Second edition
2022-04
Piston-operated volumetric
apparatus —
Part 2:
Pipettes
Appareils volumétriques à piston —
Partie 2: Pipettes
Reference number
ISO 8655-2:2022(E)
© ISO 2022
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SIST EN ISO 8655-2:2022
ISO 8655-2:2022(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
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SIST EN ISO 8655-2:2022
ISO 8655-2:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle of operation . 2
5 Adjustment .2
5.1 Basis of adjustment . 2
5.2 Initial adjustment . 2
5.3 Subsequent adjustment . 2
5.4 Adjustment for other liquid properties . 2
6 Design . 3
6.1 Types of pipette . 3
6.2 Transfer of hand warmth . 3
7 Pipette tips . 4
7.1 General . 4
7.2 Air-displacement pipette tips . 4
7.3 Positive-displacement pipette tips . 4
8 Type, designation . 5
9 Metrological performance requirements . 5
9.1 General . 5
9.2 Fixed-volume pipettes of types A and D1 . 5
9.3 Fixed-volume pipettes of type D2 . 5
9.4 Variable-volume pipettes of types A, D1 and D2 . 6
9.5 Multi-channel pipettes . 6
9.6 Calculation of maximum permissible errors for volumes not listed in Tables 1, 2
and 3 . 6
9.7 Pipette tips . 9
10 User information . 9
10.1 Pipettes . 9
10.2 Pipette tips and accessories. 10
11 Marking . .10
11.1 Pipettes . 10
11.2 Pipette tips . 10
Annex A (informative) Possible sources of error for air displacement pipettes .11
Annex B (informative) Electronic motorised air displacement pipettes and method
for testing in multi-dispensing mode .13
Bibliography .15
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SIST EN ISO 8655-2:2022
ISO 8655-2:2022(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 8655-2:2002), which has been technically
revised. It also incorporates the Technical Corrigendum ISO 8655-2:2002/Cor.1:2008.
The main changes are as follows:
— ISO 8655-7 and ISO 8655-8 have been added as normative references;
— metrological performance requirements for pipette tips have been further specified;
— Tables 1 and 2 have been revised;
— a new Table 3 has been introduced;
— a new informative Annex B for motorised pipettes has been introduced;
— former Annex A has been added as new Clause 10.
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 8655-2:2022
ISO 8655-2:2022(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.
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SIST EN ISO 8655-2:2022
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SIST EN ISO 8655-2:2022
INTERNATIONAL STANDARD ISO 8655-2:2022(E)
Piston-operated volumetric apparatus —
Part 2:
Pipettes
1 Scope
This document specifies
— metrological requirements,
— maximum permissible errors,
— requirements for marking and
— information to be provided for users,
for air-displacement (type A) and positive displacement (type D) single-channel and multi-channel
pipettes, complete with their selected tip(s) and any other essential, consumable parts, designed to
deliver the selected volume (Ex).
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 8655-1, Piston-operated volumetric apparatus — Part 1: Terminology, general requirements and user
recommendations
ISO 8655-6:2022, Piston-operated volumetric apparatus — Part 6: Gravimetric reference measurement
procedure for the determination of volume
ISO 8655-7:2022, Piston operated volumetric apparatus — Part 7: Alternative measurement procedures
for the determination of volume
ISO 8655-8:2022, Piston-operated volumetric apparatus — Part 8: Photometric reference measurement
procedure for the determination of volume
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 8655-1 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/
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SIST EN ISO 8655-2:2022
ISO 8655-2:2022(E)
4 Principle of operation
Pipettes are used to accurately handle preselected volumes. A tip is attached to the pipette. Pipettes
are typically operated using forward pipetting. Using forward pipetting, with the piston positioned at
the lower aspiration limit, the tip is dipped into the liquid to be dispensed. When moved to the upper
aspiration limit, the piston aspirates the liquid. The liquid volume to be dispensed is then expelled by
depressing or sliding the piston between the volume-defining limits. Some air-displacement pipettes
(see 6.1, Type A) have an extra air volume that can be used to expel the last drop of liquid.
See also Figure 1.
Manufacturers' instruction manuals should contain detailed and specific information about the proper
operation of pipettes.
5 Adjustment
5.1 Basis of adjustment
A pipette shall be adjusted for the delivery (Ex) of its nominal volume (or selected volume, in the case of
a variable-volume model).
For countries that have adopted the standard reference temperature of 20 °C, the adjustment shall be
for the temperature of 20 °C, a relative air humidity of 50 % and a barometric pressure of 101,3 kPa,
when handling grade 3 water as specified in ISO 3696:1987.
For those countries that have adopted a standard reference temperature of 27 °C, the adjustment shall
be for the temperature 27 °C, a relative air humidity of 50 % and a barometric pressure of 101,3 kPa,
when handling grade 3 water as specified in ISO 3696:1987.
5.2 Initial adjustment
A pipette shall be provided with an initial adjustment.
5.3 Subsequent adjustment
Some pipettes have provision for adjustment when, for example, it is found in a routine check that
the volume delivered is not within specification. Such adjustment shall be made in accordance with
the manufacturer's instructions and by reference to a measurement procedure in accordance with
ISO 8655-6, ISO 8655-7 or ISO 8655-8.
Any pipette so adjusted shall have clear, visible evidence that the initial adjustment has been modified.
This information shall also be recorded.
5.4 Adjustment for other liquid properties
Some pipettes are designed to have their factory pre-set adjustment altered by the user so that they will
dispense their specified volume when used with liquids with physical properties differing from those
of water (see Annex A for details). In such cases, the design shall prevent unintentional readjustment.
Such adjustment shall be made in accordance with the manufacturer's instructions or by reference to
the selected test procedure from ISO 8655-7 and the modifications made.
If the pipette is readjusted, it shall be clearly and unequivocally indicated on the outside of the pipette
that readjustment has been affected. The outside of the pipette shall be marked with the name of the
liquid and the adjusted volume range. This information shall be documented appropriately.
2
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SIST EN ISO 8655-2:2022
ISO 8655-2:2022(E)
6 Design
6.1 Types of pipette
A pipette may be designed as follows:
— fixed volume, designed by the manufacturer to dispense only its nominal volume, e.g. 100 μl;
— variable volume, designed by the manufacturer to dispense volumes selectable by the user within
its specified usable volume range, e.g. between 10 μl and 100 μl.
The piston may:
— either have a body of air contained between the piston and the surface of the liquid (air displacement
– Type A); or
— be in direct contact with the surface of the liquid (positive or direct displacement – Type D).
In the case of the Type D pipette, either the plunger or the capillary, or both may be reusable (Type D1)
or disposable (Type D2). See Figure 1 for details.
Type D Type A
Positive (direct) displacement Air displacement
a) Single-channel pipettes b) Multi-channel pipette
Figure 1 — Pipettes
6.2 Transfer of hand warmth
The construction of pipettes and the materials used for their manufacture shall be chosen in such a way
that any heat transmitted from the user's hand to the apparatus during periods of use is minimized.
NOTE Transfer of hand warmth will appear as a systematic drift of results (the delivered volume decreases
over time) during a series of deliveries.
3
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SIST EN ISO 8655-2:2022
ISO 8655-2:2022(E)
7 Pipette tips
7.1 General
7.1.1 The dispensing orifice of the tip shall be shaped in such a way that consistent dispensing of the
liquid to be measured is achieved. When the tip is touched against the wall of a vessel in successive
operations, any amount of liquid remaining in or around the dispensing orifice of the tip shall be
consistent.
7.1.2 In the case of sterilisable pipette tips, the sterilisation procedures indicated as appropriate by
the manufacturer in user information or on packaging (see Clause 10) shall not negatively affect the
metrological characteristics of the tips such as shape, seal and wettability.
NOTE This requirement can be assessed by comparing errors of measurement using tips which have and
have not been sterilised.
7.2 Air-displacement pipette tips
7.2.1 Air-displacement pipette tips shall be disposable parts, usually made of plastic, which fit on the
tip cone of the pipette and prevent the instrument from contact with the aspirated liquid.
7.2.2 Tips for air-displacement shall be fitted in accordance with the pipette supplier's instructions
to form a good seal between the tip and the tip cone of the pipette.
NOTE Variability of the amount of externally retained liquid or an incomplete seal will contribute to poor
precision.
Pipette tips made of plastic for pipettes with air interface are designed for single use. They shall not be
cleaned for reuse as their metrological characteristics will no longer be reliable.
Single use of a pipette tip means mounting the tip on the pipette only once, and then discarding it after
use. While the tip is mounted on the pipette, it may be used to handle several replicate aspiration and
delivery cycles, as long as a tight seal between the tip and pipette’s tip cone is maintained.
7.2.3 The form of the pipette tips to be used with a multi-channel pipette shall be such that all tips
fitted are positioned with parallel axes in the same plane in order to allow for even liquid dispensing
in the target vessels, e.g. the adjacent wells of a microplate. The bottoms of properly fitted tips shall
not vary in spacing from their nominal axes, nor from their common plane by more than ±0,5 mm for
less than 100 µl, ± 1,0 mm for 100 µl up to 350 μl and ±1,5 mm for nominal volumes exceeding 350 μl
(nominal volumes).
7.3 Positive-displacement pipette tips
7.3.1 Positive-displacement pipette tips shall consist of a plunger and a capillary which fit on the
pipette. Various materials may be used for the plunger, such as metal or plastic, and the capillary, such
as plastic or glass. These pipette tips may be reusable (D1) or disposable (D2).
7.3.2 The shape and material of the plunger and capillary shall confer a good seal of the tip, as well as
a smooth action between the plunger and the capillary, to ensure consistent dispensing of the liquid.
7.3.3 Sterilisability shall be in accordance with 7.1.2.
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SIST EN ISO 8655-2:2022
ISO 8655-2:2022(E)
8 Type, designation
Designation of a Type D1 single-channel pipette (positive displacement with reusable plunger) with a
fixed volume of 100 μl:
Pipette ISO 8655 - D1-100
Designation of a Type D2 variable-volume single-channel pipette (positive displacement with disposable
plunger/capillary), volume range variable from 20 μl to 200 μl:
Pipette ISO 8655 - D2 - 20-200
Designation of a Type A variable-volume single-channel pipette with air interface, volume range
variable from 10 μl to 100 μl:
Pipette ISO 8655 - A - 10-100
Designation of an 8-channel pipette with air interface (A) and with a fixed volume of 200 μl:
Pipette ISO 8655 - A - 200 × 8
Designation of a 12-channel pipette with air interface (A), volume range variable from 20 μl to 200 μl:
Pipette ISO 8655 - A - 20-200 × 12
9 Metrological performance requirements
9.1 General
9.1.1 General. The metrological performance of POVA (especially pipettes of type A) can be affected
in many ways. Annex A lists parameters which influence the metrological performance of pipettes and
recommendations for their handling.
9.1.2 Reference test. In order to state the metrological trueness and precision of the POVA and
thus determine its systematic and random errors, a reference measurement procedure as specified in
ISO 8655-6 and ISO 8655-8 or a measurement procedure in accordance with ISO 8655-7 shall be used.
The maximum permissible errors given in Tables 1, 2 and 3 shall apply.
9.1.3 Routine testing. Users shall establish routine testing of POVA in accordance with ISO 8655-1.
9.1.4 Further testing. In the case of electronic motorised pipettes, an additional set of measurements
can be done using dispense mode. See Annex B for more information.
9.2 Fixed-volume pipettes of types A and D1
For air-displacement pipettes (Type A) with fixed volume and for positive-displacement pipettes with
reusable plunger and capillary (Type D1) and with fixed volume, the maximum permissible errors given
in Table 1 apply.
9.3 Fixed-volume pipettes of type D2
For positive-displacement pipettes with a disposable plunger and capillary (Type D2) and with fixed
volume, the maximum permissible errors given in Table 3 apply.
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SIST EN ISO 8655-2:2022
ISO 8655-2:2022(E)
9.4 Variable-volume pipettes of types A, D1 and D2
In the case of variable-volume pipettes, the nominal volume is the greatest possible user-selectable
volume which is specified by the manufacturer. For example, a pipette with a usable volume range from
10 μl to 100 μl has a nominal volume of 100 μl.
The maximum permissible errors in Tables 1 (Type A and D1) and 3 (Type D2) apply.
Maximum permissible errors for intermediate volumes not given in Tables 1 and 3 shall be determined
according to 9.6.
NOTE 1 When not limited to 25 %, the maximum permissible errors in Tables 1 and 3 are constant over the
entire usable volume range. It is recognized that the errors of measurement of intermediate volumes in the usable
volume range
...
SLOVENSKI STANDARD
oSIST prEN ISO 8655-2:2020
01-oktober-2020
Volumetrične naprave, delujoče na bat - 2. del: Pipete (ISO/DIS 8655-2:2020)
Piston-operated volumetric apparatus - Part 2: Pipettes (ISO/DIS 8655-2:2020)
Volumenmessgeräte mit Hubkolben - Teil 2: Pipetten (ISO/DIS 8655-2:2020)
Appareils volumétriques à piston - Partie 2: Pipettes (ISO/DIS 8655-2:2020)
Ta slovenski standard je istoveten z: prEN ISO 8655-2
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 8655-2:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 8655-2:2020
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oSIST prEN ISO 8655-2:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8655-2
ISO/TC 48 Secretariat: DIN
Voting begins on: Voting terminates on:
2020-07-29 2020-10-21
Piston-operated volumetric apparatus —
Part 2:
Pipettes
Appareils volumétriques à piston —
Partie 2: Pipettes
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 8655-2:2020(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 8655-2:2020
ISO/DIS 8655-2:2020(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 8655-2:2020
ISO/DIS 8655-2:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle of operation . 2
5 Adjustment . 2
5.1 Basis of adjustment . 2
5.2 Initial adjustment . 2
5.3 Subsequent adjustment . 2
5.4 Adjustment for other liquid properties . 2
6 Design . 3
6.1 Types of pipette . 3
6.2 Transfer of hand warmth . 4
7 Pipette tips . 4
7.1 . 4
7.1.1 General. 4
7.1.2 Air-displacement pipette tips . 4
7.1.3 Positive-displacement pipette tips . 4
8 Type, designation . 5
9 Metrological performance requirements . 5
9.1 General . 5
9.1.1 Reference test . 5
9.1.2 Routine testing. 5
9.2 Fixed-volume pipettes of types A and D1 . 5
9.3 Fixed-volume pipettes of type D2 . 6
9.4 Variable-volume pipettes of types A, D1 and D2 . 6
9.5 Multi-channel pipettes . 6
9.6 Calculation of maximum permissible errors for volumes not listed in Tables 1, 2 and 3 . 6
9.7 Pipette tips . 9
10 Marking . 9
10.1 Pipettes . 9
10.2 Pipette tips . 9
Annex A (normative) Information to be provided with pipettes and tips .10
Annex B (informative) Possible sources of error for air displacement pipettes .11
Annex C (informative) Electronic motorized air displacement pipettes and method
for testing in multi-dispensing mode .13
Bibliography .15
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oSIST prEN ISO 8655-2:2020
ISO/DIS 8655-2:2020(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 4, Piston-operated instruments.
This second edition cancels and replaces the first edition (ISO 8655-2:2002 and ISO 8655-2:2002/Cor
1:2008), which has been technically revised.
The main changes compared to the previous edition are as follows:
— ISO 8655-7, ISO 8655-8 and ISO 8655-9 have been added as normative references;
— Metrological Performance requirements for pipette tips have been further specified;
— Tables 1 and 2 have been revised;
— A new Table 3 has been introduced;
— A new informative Annex C for motorized pipettes has been introduced;
— Annex A has been revised.
A list of all parts in the ISO 8655 series can be found on the ISO website.
Annex A forms a normative part of this part of ISO 8655. Annex B and Annex C are for information only.
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 8655-2:2020
ISO/DIS 8655-2:2020(E)
Introduction
ISO 8655 addresses the needs of:
— manufacturers, as a basis for quality control including, where appropriate, the issuance of
manufacturers’ declarations;
— calibration laboratories, test houses, users of the equipment and other bodies as a basis for
independent calibration, verification 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 8655-2:2020
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oSIST prEN ISO 8655-2:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 8655-2:2020(E)
Piston-operated volumetric apparatus —
Part 2:
Pipettes
1 Scope
This part of ISO 8655 specifies
— metrological requirements,
— maximum permissible errors,
— requirements for marking and
— information to be provided for users,
for air-displacement (type A) and positive displacement (type D) single-channel and multi-channel
pipettes, complete with their selected tip(s) and any other essential, consumable parts, designed to
deliver the selected volume (Ex).
NOTE General requirements and definitions of terms for piston-operated volumetric apparatus are given
in ISO 8655-1. 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. Alternative methods for the determination of volume are described in ISO 8655-7. For safety
requirements of electrically powered pipettes, see regional or national safety standards.
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 3696:1991, 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 8655-6:2020, Piston-operated volumetric apparatus — Part 6: Gravimetric reference measurement
procedure for the determination of volume
ISO/DIS 8655-7:2020, Piston operated volumetric apparatus — Part 7: Alternative test methods 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
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/DIS 8655-1:2020 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
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oSIST prEN ISO 8655-2:2020
ISO/DIS 8655-2:2020(E)
— IEC Electropedia: available at http:// www .electropedia .org/
4 Principle of operation
Pipettes are used to accurately handle preselected volumes. The tip is attached to the pipette. Pipettes
are typically operated using forward pipetting. Using forward pipetting, with the piston positioned at
the lower aspiration limit, the tip is dipped into the liquid to be dispensed. When moved to the upper
aspiration limit, the piston aspirates the liquid. The liquid volume to be dispensed is then expelled by
depressing or sliding the piston between the volume-defining limits. Some air-displacement pipettes
(see 6.1, Type A) have an extra air volume which can be used to expel the last drop of liquid.
See also Figure 1.
Manufacturers' instruction manuals should contain detailed and specific information about the proper
operation of pipettes.
5 Adjustment
5.1 Basis of adjustment
A pipette shall be adjusted for the delivery (Ex) of its nominal volume (or selected volume, in the case of
a variable-volume model).
For countries that have adopted the standard reference temperature of 20 °C, the adjustment shall be
for the temperature 20 °C, a relative air humidity of 50 % and a barometric pressure of 101,3 kPa, when
handling grade 3 water as specified in ISO 3696.
For those countries that have adopted a standard reference temperature of 27 °C, the adjustment shall
be for the temperature 27 °C, a relative air humidity of 50 % and a barometric pressure of 101,3 kPa,
when handling grade 3 water as specified in ISO 3696.
5.2 Initial adjustment
A pipette shall be provided with an initial adjustment.
5.3 Subsequent adjustment
Some pipettes have provision for adjustment when, for example, it is found in a routine check that
the volume delivered is not within specification. Such adjustment shall be made according to the
manufacturer's instructions and by reference to a measurement procedure according to ISO 8655-6,
ISO 8655-7 or ISO 8655-8.
Any pipette so adjusted shall have clear, visible evidence that the initial adjustment has been modified.
This information shall also be recorded.
5.4 Adjustment for other liquid properties
Some pipettes are designed to have their factory pre-set adjustment altered by the user so that they will
dispense their specified volume when used with liquids with physical properties differing from those of
water (see Annex B for details). In such cases, the design shall prevent unintentional readjustment. Such
adjustment shall be made according to the manufacturer's instructions or by reference to the selected
test procedure from ISO 8655-7 and the modifications made.
If the pipette is readjusted, it shall be clearly and unequivocally indicated on the outside of the pipette
that readjustment has been affected. The outside of the pipette shall be marked with the name of the
liquid and the adjusted volume range. This information shall be documented appropriately.
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oSIST prEN ISO 8655-2:2020
ISO/DIS 8655-2:2020(E)
6 Design
6.1 Types of pipette
A pipette may be designed as follows:
— fixed volume, designed by the manufacturer to dispense only its nominal volume, e.g. 100 μl;
— variable volume, designed by the manufacturer to dispense volumes selectable by the user within
its specified useable volume range, e.g. between 10 μl and 100 μl.
The piston may
— either have a body of air contained between the piston and the surface of the liquid (air displacement
– Type A); or
— be in direct contact with the surface of the liquid (positive or direct displacement – Type D).
In the case of the type D pipette, either the plunger or the capillary, or both may be reusable (Type D1)
or disposable (Type D2). See Figure 1 for details.
Type D Type A
Positive (direct) displacement Air displacement
a) Single-channel pipettes b) Multi-channel pipette
Figure 1 — Pipettes
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oSIST prEN ISO 8655-2:2020
ISO/DIS 8655-2:2020(E)
6.2 Transfer of hand warmth
The construction of pipettes and the materials used for their manufacture shall be chosen in such a way
that any heat transmitted from the user's hand to the apparatus during periods of use is minimized.
NOTE Transfer of hand warmth will appear as a systematic drift of results (the delivered volume decreases
over time) during a series of deliveries.
7 Pipette tips
7.1
7.1.1 General
7.1.1.1 The dispensing orifice of the tip shall be shaped in such a way that consistent dispensing of
the liquid to be measured is achieved. When the tip is touched against the wall of a vessel in successive
operations, any amount of liquid remaining in or around the dispensing orifice of the tip shall be
consistent.
7.1.1.2 In the case of sterilisable pipette tips the sterilisation procedures indicated as appropriate
by the manufacturer in user information or on packaging (see Annex A) shall not negatively affect the
metrological characteristics of the tips such as shape, seal and wettability.
NOTE This requirement can be assessed by comparing errors of measurement using tips which have and
have not been sterilised.
7.1.2 Air-displacement pipette tips
7.1.2.1 Air-displacement pipette tips shall be disposable parts, usually made of plastic, which fit on the
tip cone of the pipette and prevent the instrument from contact with the aspirated liquid.
7.1.2.2 Tips for air-displacement shall be fitted in accordance with the pipette supplier's instructions
to form a good seal between the tip and the tip cone of the pipette.
NOTE Variability of amount of externally retained liquid or an incomplete seal will contribute to poor
precision.
Pipette tips made of plastic for pipettes with air interface are designed for single use. They shall not be
cleaned for reuse as their met
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