National foreword

This British Standard is the UK implementation of EN ISO 22916:2022. It is identical to ISO 22916:2022. It supersedes BS ISO 22916:2022, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee LBI/1/2, Laboratory Equipment.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 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 foreword

The text of ISO 22916:2022 has been prepared by Technical Committee ISO/TC 48 "Laboratory equipment” 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.

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.

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 technology and cross material; for instance leakage test, burst pressure tests and flow throughput tests. The test protocol is developed considering the material of the chips, the temperature and pressure range of operation. From studies of the products on the market, a number of application classes with specific temperature and pressure ranges have been defined, that will provide the boundary conditions for the tests to be developed. Ultimately, these tests will lead to quicker access to the market.

1 Scope

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.

2 Normative references

3 Terms and definitions

4 General dimension tolerances

5 Chip reference point and topology

5.1 Chip topology

5.2 Naming of the chip

5.3 Reference point

6 Microfluidic chip dimensions

6.1 Chip thickness

6.2 Outer chip dimensions for microplate compatibility

6.3 Outer chip dimensions for microscope slide compatibility

6.4 Outer chip dimensions close to credit card format

6.5 Microfluidic building blocks

7 Microfluidic top connections

7.1 General

7.2 Port pitch

7.3 Port diameter

7.4 Distance between ports and edges

7.5 Port nomenclature

7.6 Interfacing area

7.7 Clamping zone

8 Microfluidic side connections

8.1 General

8.2 Port pitch

8.3 Port size and shape

8.4 Distance between ports and edges

8.5 Port nomenclature

8.6 Clamping zone

9 Application classes

Bibliography

BS EN ISO 22916:2022

Microfluidic devices. Interoperability requirements for dimensions, connections and initial device classification

Current

Published:

31 Jul 2025