SIST EN ISO 22916:2023

Microfluidic devices - Interoperability requirements for dimensions, connections and initial device classification (ISO 22916:2022)

This document specifies requirements for the seamless integration with other microfluidic components and systems to facilitate the process of designing new microfluidic devices (e.g. microfluidic chips, sensors, actuators, connectors).
This document is applicable to devices in the field of “microfluidics” needing microfluidic interconnections.

Mikrofluidikgeräte - Interoperabilitätsanforderungen für Abmessungen, Anschlüsse und anfängliche Geräteklassifizierung (ISO 22916:2022)

Dispositifs microfluidiques - Exigences d’interopérabilité concernant les dimensions, les connexions et la classification initiale des dispositifs (ISO 22916:2022)

Le présent document spécifie les exigences pour la bonne intégration avec d’autres composants et systèmes microfluidiques, afin de faciliter le processus de conception de nouveaux dispositifs microfluidiques (par exemple, puces, capteurs, actionneurs, connecteurs microfluidiques).
Le présent document est applicable aux dispositifs dans le domaine de la microfluidique nécessitant des interconnexions microfluidiques.

Mikrofluidne naprave - Zahteve za interoperabilnost dimenzij, priključkov in začetne razvrstitve naprav (ISO 22916:2022)

Ta dokument določa zahteve za nemoteno integracijo z drugimi mikrofluidnimi komponentami in sistemi, s čimer se poenostavi postopek načrtovanja novih mikrofluidnih naprav (npr. mikrofluidna vezja, senzorji, prožila, priključki).
Uporablja se za naprave na področju »mikrofluidike«, pri katerih so potrebne mikrofluidne medsebojne povezave.

General Information

• Status: Published
• Public Enquiry End Date: 22-Nov-2022
• Publication Date: 22-Jan-2023
• ICS: 71.040.20 - Laboratory ware and related apparatus
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 04-Jan-2023
• Due Date: 11-Mar-2023
• Completion Date: 23-Jan-2023
• Ref Project: EN ISO 22916:2022 - Microfluidic devices - Interoperability requirements for dimensions, connections and initial device classification (ISO 22916:2022)

Overview

EN ISO 22916:2022 - Microfluidic devices: Interoperability requirements for dimensions, connections and initial device classification - specifies minimum interface requirements to enable seamless integration of microfluidic components (chips, sensors, actuators, connectors). Adopted by CEN as EN ISO 22916:2022, this standard targets interoperability in the microfluidics ecosystem so devices from different suppliers can be connected, tested and deployed with reduced custom engineering effort.

Key topics

• Scope and applicability: Requirements for devices in the field of microfluidics that require microfluidic interconnections.
• Reference and terminology: Uses ISO 10991 vocabulary for consistent definitions.
• Chip topology and reference point: Guidance on chip layout, naming and a defined reference point to enable repeatable positioning and interfacing.
• Dimensional requirements: General tolerances plus specific guidance for chip thickness and outer dimensions aligned to common formats (microplate compatibility, microscope slide format, credit-card-like formats).
• Building blocks: Standardized microfluidic building-block concepts to simplify design reuse and modularity.
• Top and side connections: Specifications for port pitch, port diameter/shape, distances from edges, port nomenclature, interfacing areas and clamping zones to ensure reliable mechanical and fluidic connections.
• Application classes: Initial device classification with temperature and pressure boundary conditions that inform standardized testing (e.g., leakage, burst pressure, flow throughput) and product readiness.

Applications and users

EN ISO 22916:2022 is practical for:

• Device designers and OEMs creating microfluidic chips, cartridges and connectors - to design components that plug into existing systems.
• System integrators and instrument manufacturers who need predictable interfaces for pumps, sensors and peripheral modules.
• Research labs and academia seeking to swap or combine chips from multiple sources without redesigning fixtures.
• Test laboratories and quality teams using the application-class boundaries to develop cross‑technology tests and validation protocols.
• Regulatory and procurement teams evaluating interoperability and second‑source availability.

Adoption of this standard reduces custom tooling, accelerates prototyping, and simplifies scale-up and manufacturing transitions.

Related standards

• ISO 10991 - Micro process engineering - Vocabulary (normative reference for terms).
• IWA 23:2016 - Earlier guidance that has been technically revised and integrated into ISO 22916:2022.

Keywords: EN ISO 22916:2022, microfluidic devices, interoperability, microfluidic chips, connectors, device classification, microfluidics standard.

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2023
Mikrofluidne naprave - Zahteve za interoperabilnost dimenzij, priključkov in
začetne razvrstitve naprav (ISO 22916:2022)
Microfluidic devices - Interoperability requirements for dimensions, connections and
initial device classification (ISO 22916:2022)
Mikrofluidikgeräte - Interoperabilitätsanforderungen für Abmessungen, Anschlüsse und
anfängliche Geräteklassifizierung (ISO 22916:2022)
Dispositifs microfluidiques - Exigences d’interopérabilité concernant les dimensions, les
connexions et la classification initiale des dispositifs (ISO 22916:2022)
Ta slovenski standard je istoveten z: EN ISO 22916:2022
ICS:
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 22916
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2022
EUROPÄISCHE NORM
ICS 71.040.20
English Version
Microfluidic devices - Interoperability requirements for
dimensions, connections and initial device classification
(ISO 22916:2022)
Dispositifs microfluidiques - Exigences Mikrofluidikgeräte - Interoperabilitätsanforderungen
d'interopérabilité concernant les dimensions, les für Abmessungen, Anschlüsse und anfängliche
connexions et la classification initiale des dispositifs Geräteklassifizierung (ISO 22916:2022)
(ISO 22916:2022)
This European Standard was approved by CEN on 20 December 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, Türkiye 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 22916:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 22916:2022 has been prepared by Technical Committee ISO/TC 138 "Plastics pipes,
fittings and valves for the transport of fluids” of the International Organization for Standardization
(ISO) and has been taken over as EN ISO 22916:2022 by 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 June 2023, and conflicting national standards shall be
withdrawn at the latest by June 2023.
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.
Any feedback and questions on this document should be directed to the users’ national standards body.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 22916:2022 has been approved by CEN as EN ISO 22916:2022 without any modification.

INTERNATIONAL ISO
STANDARD 22916
First edition
2022-01
Microfluidic devices —
Interoperability requirements for
dimensions, connections and initial
device classification
Dispositifs microfluidiques — Exigences d’interopérabilité concernant
les dimensions, les connexions et la classification initiale des
dispositifs
Reference number
ISO 22916:2022(E)
ISO 22916:2022(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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 22916:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 General dimension tolerances.1
5 Chip reference point and topology.2
5.1 Chip topology . 2
5.2 Naming of the chip . 3
5.3 Reference point . 3
6 Microfluidic chip dimensions .5
6.1 Chip thickness . 5
6.2 Outer chip dimensions for microplate compatibility . 5
6.3 Outer chip dimensions for microscope slide compatibility . 6
6.4 Outer chip dimensions close to credit card format . 7
6.5 Microfluidic building blocks . 8
7 Microfluidic top connections .9
7.1 General . 9
7.2 Port pitch . 9
7.3 Port diameter . 9
7.4 Distance between ports and edges . 9
7.5 Port nomenclature. 9
7.6 Interfacing area . 10
7.7 Clamping zone . 11
8 Microfluidic side connections .12
8.1 General .12
8.2 Port pitch . 12
8.3 Port size and shape .12
8.4 Distance between ports and edges . 13
8.5 Port nomenclature. 13
8.6 Clamping zone . 13
9 Application classes .13
Bibliography .15
iii
ISO 22916:2022(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.
This first edition of ISO 22916 cancels and replaces IWA 23:2016, which has been technically revised.
The main changes are as follows:
— the content of IWA 23 was transferred into a standard for the first time;
— the terms and definitions have been removed in the present document and it refers mainly to
ISO 10991;
— the rationale behind technical decisions in IWA 23 have been removed from the present document;
— the geometrical pitch dimensions are included in Clause 4;
— the device classification is included in Clause 9;
— further information have been introduced in the present document.
NOTE IWA 23 initiated the standardization effort in microfluidics and presented mainly the terms and
definitions, the geometrical pitch rationale and dimensions and the device classification rationale and proposal.
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 22916:2022(E)
Introduction
This document was developed in response to microfluidics community demand for minimum
specifications for interoperability of microfluidics components, since most of the microfluidics products
are produced internally with custom dimensions and characteristics.
Microfluidics based diagnostics have been shown over the years to be viable alternatives to conventional
macroscale analysis systems, and in some applications provide analytical capabilities which are not
possible using macroscale systems. Hence, exploitation of microfluidics will play an important role for
next generation of medical devices. However, there are many (potential) applications for microfluidics,
and also many technologies and materials being used. This diversity is a problem when it comes to
combining microfluidic components. Researchers do not want to spend much time on side issues like
correct connection of tooling; they also want to use chips from different suppliers without needing to
change their whole experimental setup; and they want their developed products to go as smoothly as
possible into production. Providers of analytical services do not want their limited laboratory space
cluttered with a multitude of incompatible instruments. Chemical engineers want easy interconnection
between pumps, sensors and reactors, and finally, operational managers want a second source for
their products. In short interoperability and therefore standardizing the interfaces between them is
important.
Another essential requirement for interoperability is standardization of testing. Testing may be partly
very application specific, but there are also tests that are to be used cross application, cross technol
...