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)

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

General Information

Status
Published
Publication Date
30-Mar-2023
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
21-Dec-2022
Due Date
08-Nov-2024
Completion Date
21-Dec-2022

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SLOVENSKI STANDARD
SIST EN ISO 22916:2023
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
SIST EN ISO 22916:2023 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 22916:2023
---------------------- Page: 2 ----------------------
SIST EN ISO 22916:2023
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 22916:2023
EN ISO 22916:2022 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 22916:2023
EN ISO 22916:2022 (E)
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.

---------------------- Page: 5 ----------------------
SIST EN ISO 22916:2023
---------------------- Page: 6 ----------------------
SIST EN ISO 22916:2023
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 2022
---------------------- Page: 7 ----------------------
SIST EN ISO 22916:2023
ISO 22916:2022(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
© ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 22916:2023
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 2022 – All rights reserved
---------------------- Page: 9 ----------------------
SIST EN ISO 22916:2023
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.
© ISO 2022 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 22916:2023
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

...

SLOVENSKI STANDARD
oSIST prEN ISO 22916:2022
01-oktober-2022
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: prEN ISO 22916
ICS:
71.040.20 Laboratorijska posoda in Laboratory ware and related
aparati apparatus
oSIST prEN ISO 22916:2022 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 22916:2022
---------------------- Page: 2 ----------------------
oSIST prEN ISO 22916:2022
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 2022
---------------------- Page: 3 ----------------------
oSIST prEN ISO 22916:2022
ISO 22916:2022(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
© ISO 2022 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 22916:2022
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 2022 – All rights reserved
---------------------- Page: 5 ----------------------
oSIST prEN ISO 22916:2022
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.
© ISO 2022 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 22916:2022
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 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.

© ISO 2022 – All rights reserved
---------------------- Page: 7 ----------------------
oSIST prEN ISO 22916:2022
---------------------- Page: 8 ----------------------
oSIST prEN ISO 22916:2022
INTERNATIONAL STANDARD ISO 22916:2022(E)
Microfluidic devices — Interoperability requirements for
dimensions, connections and initial device classification
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

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 10991, Micro process engineering — Vocabulary
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 10991 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
— IEC Electropedia: available at https:// www .electropedia .org/
4 General dimension tolerances

Table 1 and Table 2 present the recommended general dimension tolerances regarding port pitches,

chip thicknesses and port dimensions respectively for to
...

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