EN ISO 8655-4:2022
(Main)Piston-operated volumetric apparatus - Part 4: Dilutors (ISO 8655-4:2022)
Piston-operated volumetric apparatus - Part 4: Dilutors (ISO 8655-4:2022)
This document specifies
— metrological requirements,
— maximum permissible errors,
— requirements for marking and
— information to be provided for users,
for dilutors with a sample uptake capacity (In) from 5 μl to 1 ml and a diluent capacity (Ex) from 50 μl to 100 ml. They are designed to deliver the sample and diluent together in measured proportion and measured volume.
Volumenmessgeräte mit Hubkolben - Teil 4: Dilutoren (ISO 8655-4:2022)
Dieses Dokument trifft Festlegungen hinsichtlich
— metrologischer Anforderungen,
— Fehlergrenzen,
— Anforderungen an die Kennzeichnung und
— Benutzerinformation
von Dilutoren mit einem Nennvolumen für die Probenaufnahme (In) von 5 µl bis 1 ml und einem Nennvolumen für die Verdünnung (Ex) von 50 µl bis 100 ml. Sie dienen zur gemeinsamen Abgabe der Probe mit der Verdünnungsflüssigkeit in abgemessenem Mengenverhältnis und Volumen.
Appareils volumétriques à piston - Partie 4: Diluteurs (ISO 8655-4:2022)
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 diluteurs d’une capacité de prélèvement d’échantillon (In) allant de 5 µl à 1 ml et d’une capacité de diluant (Ex) allant de 50 µl à 100 ml. Ceux-ci sont conçus pour distribuer l’échantillon et le diluant ensemble dans une proportion connue et dans un volume mesuré.
Volumetrične naprave, delujoče na bat - 4. del: Razredčevalci (ISO 8655-4:2022)
Ta dokument določa: – meroslovne zahteve; – največje dopustne pogreške; – zahteve za označevanje; in – informacije, predvidene za uporabnike za dilutorje s predelom za zajem vzorca (In) od 5 μl do 1 ml in predelom za redčilo (Ex) od 50 μl to 100 ml. Namenjeni so hkratnemu dovajanju vzorca in redčila z izmerjenim razmerjem in izmerjeno prostornino.
General Information
Relations
Overview
EN ISO 8655-4:2022 - "Piston-operated volumetric apparatus - Part 4: Dilutors" specifies metrological requirements, maximum permissible errors, marking and user information for laboratory dilutors. The standard applies to dilutors with a sample uptake capacity (In) of 5 µl to 1 ml and a diluent capacity (Ex) of 50 µl to 100 ml. It replaces the 2002 edition and aligns dilutor testing and documentation with the ISO 8655 series for piston-operated volumetric apparatus.
Key topics and requirements
- Scope and principle: Defines operation of dilutors that aspirate a measured sample and deliver it together with a measured diluent volume; covers manual, electrical, pneumatic or hydraulic drives and hand‑held, bottle‑top or bench‑top configurations, including automated analyser components.
- Metrological performance: Requires determination of system trueness and precision using gravimetric methods (total system includes pistons, valves, drive, uptake/delivery probe, tubing and any change‑over unit).
- Maximum permissible errors (MPEs): Tables list MPEs for nominal volumes; the standard also gives a formula to calculate MPEs for selected volumes:
- e_Vs = (V_nom / V_s) × e_Vnom
- Values do not apply below 10% of nominal volume; calculated MPEs are capped at 25%.
- Adjustment: Specifies initial and subsequent adjustment procedures and reference conditions (standard reference temperature 20 °C or 27 °C, 50% RH, 101.3 kPa, using grade 3 water per ISO 3696).
- Marking and user information: Requires clear marking and detailed manufacturer instructions, including evidence and records when subsequent adjustments are performed.
- Testing references: Measurement and verification by ISO 8655-6 (gravimetric reference procedure) or ISO 8655-7 (alternative procedures).
Practical applications and users
EN ISO 8655-4:2022 is intended for:
- Manufacturers - product design, quality control and performance declarations for dilutors.
- Calibration laboratories and test houses - to perform verification, calibration and routine checks using standardized gravimetric methods.
- Clinical, pharmaceutical and research laboratories - to select and validate dilutors for sample preparation, serial dilution and automated workflows.
- Regulatory and QA teams - to ensure documented compliance of volumetric dilutor equipment.
Adoption of this standard helps ensure accurate, traceable dilution steps, reduce assay variability and support compliance in laboratory workflows.
Related standards
- ISO 8655-1 - Terminology, general requirements and user recommendations
- ISO 8655-6 - Gravimetric reference measurement procedure for determination of volume
- ISO 8655-7 - Alternative measurement procedures for determination of volume
Keywords: EN ISO 8655-4:2022, dilutors, piston-operated volumetric apparatus, metrological requirements, maximum permissible errors, gravimetric measurement, calibration, laboratory equipment.
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2022
Nadomešča:
SIST EN ISO 8655-4:2002
SIST EN ISO 8655-4:2002/AC:2009
Volumetrične naprave, delujoče na bat - 4. del: Razredčevalci (ISO 8655-4:2022)
Piston-operated volumetric apparatus - Part 4: Dilutors (ISO 8655-4:2022)
Volumenmessgeräte mit Hubkolben - Teil 4: Dilutoren (ISO 8655-4:2022)
Appareils volumétriques à piston - Partie 4: Diluteurs (ISO 8655-4:2022)
Ta slovenski standard je istoveten z: EN ISO 8655-4:2022
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 8655-4
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 17.060 Supersedes EN ISO 8655-4:2002, EN ISO 8655-
4:2002/AC:2009
English Version
Piston-operated volumetric apparatus - Part 4: Dilutors
(ISO 8655-4:2022)
Appareils volumétriques à piston - Partie 4: Diluteurs Volumenmessgeräte mit Hubkolben - Teil 4: Dilutoren
(ISO 8655-4:2022) (ISO 8655-4:2022)
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 8655-4:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 8655-4:2022) 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 8655-4:2002.
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 8655-4:2022 has been approved by CEN as EN ISO 8655-4:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 8655-4
Second edition
2022-04
Piston-operated volumetric
apparatus —
Part 4:
Dilutors
Appareils volumétriques à piston —
Partie 4: Diluteurs
Reference number
ISO 8655-4:2022(E)
ISO 8655-4:2022(E)
© 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 8655-4:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle of operation . 1
5 Adjustment .2
5.1 Basis of adjustment . 2
5.2 Initial adjustment . 2
5.3 Subsequent adjustment . 2
6 Metrological performance requirements . 3
6.1 General . 3
6.2 Calculation of maximum permissible errors not given in Tables 1 and 2 . 3
7 User information . 5
8 Marking . . 6
iii
ISO 8655-4:2022(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 8655-4:2002), which has been technically
revised. It also incorporates the Technical Corrigendum ISO 8655-4:2002/Cor.1:2008.
The main changes are as follows:
— ISO 8655-7 has been added as a normative reference;
— Tables 1 and 2 have been revised.
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.
iv
© ISO 2
...
Frequently Asked Questions
EN ISO 8655-4:2022 is a standard published by the European Committee for Standardization (CEN). Its full title is "Piston-operated volumetric apparatus - Part 4: Dilutors (ISO 8655-4:2022)". This standard covers: This document specifies — metrological requirements, — maximum permissible errors, — requirements for marking and — information to be provided for users, for dilutors with a sample uptake capacity (In) from 5 μl to 1 ml and a diluent capacity (Ex) from 50 μl to 100 ml. They are designed to deliver the sample and diluent together in measured proportion and measured volume.
This document specifies — metrological requirements, — maximum permissible errors, — requirements for marking and — information to be provided for users, for dilutors with a sample uptake capacity (In) from 5 μl to 1 ml and a diluent capacity (Ex) from 50 μl to 100 ml. They are designed to deliver the sample and diluent together in measured proportion and measured volume.
EN ISO 8655-4:2022 is classified under the following ICS (International Classification for Standards) categories: 17.060 - Measurement of volume, mass, density, viscosity; 71.040.20 - Laboratory ware and related apparatus. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 8655-4:2022 has the following relationships with other standards: It is inter standard links to EN ISO 8655-4:2002, EN ISO 8655-4:2002/AC:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN ISO 8655-4:2022 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
The EN ISO 8655-4:2022 standard provides a comprehensive framework for the evaluation and use of piston-operated volumetric apparatus specifically focused on dilutors. This document is critical for organizations that rely on precise liquid measurements, particularly in laboratories and industrial settings where accurate dilution of samples is essential. One of the key strengths of this standard is its detailed specification of metrological requirements, ensuring that users can achieve high accuracy in their dilutions. The inclusion of maximum permissible errors allows users to maintain consistency and reliability in their measurements, thereby enhancing the overall quality of their results. This focus on precision is vital for industries where regulatory compliance is essential, making the standard highly relevant. Furthermore, the EN ISO 8655-4:2022 standard lays out clear requirements for marking and information to be provided for users. This aspect is particularly beneficial, as it enhances user understanding and facilitates the correct usage of dilutors. By standardizing the labeling and instructional requirements, this document aids in reducing errors in settings that require meticulous handling of samples and diluents. The specified sample uptake capacity of 5 μl to 1 ml and diluent capacity ranging from 50 μl to 100 ml expands the applicability of this standard across various fields, from pharmaceutical labs to environmental testing. This broad scope ensures that the standard can be utilized effectively in diverse situations where precise dilution processes are necessary. Overall, the EN ISO 8655-4:2022 standard stands out not only for its rigorous metrological and usability requirements but also for its applicability in ensuring high standards of accuracy in volumetric measurements. Its relevance is further amplified by its alignment with international standards, fostering global consistency in the field of sample dilution.
EN ISO 8655-4:2022 표준은 피스톤 작동식 부피 측정 기구의 일환으로, 희석기를 위한 실용적인 지침과 기준을 제공합니다. 이 문서는 희석기의 측정 요구사항, 최대 허용 오차, 표시 요구 사항, 사용자에게 제공해야 할 정보 등을 명확히 규정하고 있습니다. 이 표준의 범위는 샘플 업테이크 용량이 5μl에서 1ml까지, 희석 용액의 용량이 50μl에서 100ml까지인 희석기를 대상으로 하고 있으며, 이는 실험에서 요구되는 정밀한 측정을 지원합니다. 희석기는 샘플과 희석제를 혼합해 측정된 비율로 전달하는 데 사용되며, 이러한 기능은 정확한 분석을 위해 필수적입니다. EN ISO 8655-4:2022의 강점 중 하나는 메트롤로지 요구사항을 세밀하게 규정하고 있다는 점입니다. 이는 실험실에서의 신뢰성을 높이고, 사용자가 기기의 성능을 충분히 이해하고 활용할 수 있도록 돕습니다. 또한, 최대 허용 오차를 명시함으로써 사용자들은 실험 과정에서 발생할 수 있는 오류를 미리 인지하고 예방할 수 있습니다. 이 표준은 관련 업계에서의 희석기의 설계 및 제작에 있어서 가장 중요한 지침으로 자리 잡고 있으며, 실험실 내에서의 일관성 있고 정확한 결과를 보장하는 데 기여합니다. 또한, 사용자에게 필요한 정보와 표시 요구 사항을 설정함으로써, 기기의 사용성을 향상시키고, 사용자 경험을 개선하는 데 중요한 역할을 합니다. 결론적으로, EN ISO 8655-4:2022는 현대 실험실에서 피스톤 작동식 희석기의 신뢰성과 정확성을 보장하는 데 있어 필수적인 표준으로, 다양한 분야에서 광범위하게 활용될 수 있습니다. 이 표준은 모든 사용자들이 효과적으로 기기를 사용할 수 있게 하여, 정밀한 실험 결과를 도출하는 데 중대한 기여를 합니다.
La norme EN ISO 8655-4:2022, intitulée "Appareils volumétriques à piston - Partie 4 : Diluteurs", établit un cadre métrologique essentiel pour les diluteurs, définissant des exigences précises à respecter. Cette norme se concentre sur les exigences métrologiques, les erreurs maximales admissibles, les conditions de marquage, ainsi que les informations nécessaires à fournir aux utilisateurs. Le champ d'application de cette norme couvre spécifiquement les diluteurs ayant une capacité d'aspiration d'échantillons (In) variant de 5 μl à 1 ml et une capacité de diluant (Ex) allant de 50 μl à 100 ml. Cela en fait un document particulièrement pertinent pour les laboratoires et les établissements de recherche qui utilisent des diluteurs pour mixer des échantillons de manière précise. Parmi ses points forts, la norme EN ISO 8655-4:2022 présente une approche rigoureuse en matière de métrologie, garantissant des résultats fiables grâce à la définition d'erreurs maximales admissibles. Cette précision est cruciale, car elle assure une meilleure qualité des analyses et contribue à la fiabilité des données scientifiques et techniques. En outre, les exigences de marquage et les informations à fournir pour les utilisateurs favorisent la traçabilité et l'utilisation appropriée des appareils, renforçant ainsi la sécurité des opérations en laboratoire. Cela témoigne de l'engagement de la norme envers l'amélioration continue des pratiques métrologiques dans le domaine des diluteurs. La pertinence de la norme EN ISO 8655-4:2022 ne peut être sous-estimée, car elle répond à un besoin croissant de standardisation dans les méthodes de dilution et de manipulation d'échantillons. En intégrant des critères clairs et uniforme, cette norme favorise également l'harmonisation des processus à l'échelle internationale, ce qui est essentiel pour maintenir la conformité et les normes de qualité à travers différents secteurs.
Die Norm EN ISO 8655-4:2022 beschreibt die wesentlichen metrologischen Anforderungen und Funktionsweisen von Kolbenbetriebenen volumetrischen Geräten, insbesondere von Verdünnungsmitteln. Sie richtet sich an Fachleute, die mit der Messung von Flüssigkeiten in Laborumgebungen arbeiten, und stellt sicher, dass die Geräte zuverlässig und genau arbeiten. Ein wesentlicher Aspekt der Norm ist die Festlegung der maximal zulässigen Fehler, die für Verdünnungsmittel mit einer Probenaufnahmefähigkeit (In) von 5 μl bis 1 ml und einer Verdünnerkapazität (Ex) von 50 μl bis 100 ml anwendbar sind. Diese spezifischen Anforderungen tragen dazu bei, die Qualität und Genauigkeit der Ergebnisse in der chemischen und biomedizinischen Analyse zu garantieren. Durch die strikten metrologischen Vorgaben wird sichergestellt, dass die Geräte in verschiedenen Anwendungen, von der klinischen Diagnostik bis zur Forschungsumgebung, standardisiert und zuverlässig verwendet werden können. Darüber hinaus umfasst die Norm Anforderungen an die Kennzeichnung und die Informationen, die den Benutzern zur Verfügung gestellt werden müssen. Dies fördert die Benutzerfreundlichkeit und das Verständnis der Benutzer, was besonders wichtig ist für die Anwendung in einem Laborumfeld, in dem präzise Messungen notwendig sind. Die Relevanz der EN ISO 8655-4:2022 liegt in ihrer Fähigkeit, die Standardisierung von Verdünnungsmitteln zu fördern, was letztendlich zu einer höheren Nachvollziehbarkeit und Konsistenz in wissenschaftlichen Experimenten und deren Ergebnissen führt. Diese Norm ist ein unverzichtbares Werkzeug für Unternehmen und Labore, die Wert auf Präzision und Klarheit in ihren Messprozessen legen.
EN ISO 8655-4:2022は、ピストン式体積器具の中で濃度を調整するための装置についての規格であり、特に調整装置（ダイリューター）に焦点を当てています。この文書は、5μlから1mlのサンプル摂取容量（In）および50μlから100mlの溶媒容量（Ex）を持つダイリューターの計測要求を明確に医療や科学の分野での利用に適した基準を設定しています。 この標準の大きな強みは、計測技術における要件が詳細に説明されていることです。特に最大許容誤差に関する基準が設けられており、ユーザーは製品の精度を確保するために必要な情報を容易に理解できます。また、マーキング要件も含まれており、ユーザーに対して重要な情報が明確に示されることによって、適切な使用法を促進します。 さらに、この規格はダイリューターが他の計測器具と比較してどのように異なるかを示す重要なフレームワークを提供しています。これにより、製造業者や研究者は、規格に準拠した高品質の製品を開発する際の指標として利用することができます。また、グローバルな文脈においても、EN ISO 8655-4:2022は国際基準に基づいており、国や地域を問わず関連する領域での一貫した利用が期待されます。 EN ISO 8655-4:2022は、ダイリューターに関する顧客のニーズと市場の要求に応じた実用的かつ信頼性の高い標準を提供しており、メトロロジーの領域での重要性を強調しています。この文書に沿って製品を設計・製造することは、企業の競争力を高める要因となり、ユーザーにとっても信頼性の高い結果をもたらすことでしょう。
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