Interoperability of microfluidic devices -- Guidelines for pitch spacing dimensions and initial device classification

IWA 23:2016 is a consensus document developed by the workshop participants and observers in response to the need for standardization and harmonization of pitch spacing dimension, initial device classification and terminology of relevance. IWA 23:2016 will serve as a guideline and is applicable to various interested parties and stakeholders in the microfluidics community. IWA 23:2016: - specifies geometrical standards in relation to pitch connector dimensions of microfluidic devices, - specifies an initial device classification rules, and - defines terms of relevance.

Interopérabilité des dispositifs microfluidiques -- Lignes directrices relatives aux valeurs du pas et à la classification initiale des dispositifs

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Status
Published
Publication Date
23-Aug-2016
Current Stage
6060 - International Standard published
Start Date
11-Jul-2016
Completion Date
24-Aug-2016
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INTERNATIONAL IWA
WORKSHOP 23
AGREEMENT
First edition
2016-09-01
Interoperability of microfluidic
devices — Guidelines for pitch
spacing dimensions and initial device
classification
Interopérabilité des dispositifs microfluidiques — Lignes directrices
pour les dimensions d’un pas d’espacement et le classement initial de
l’appareil
Reference number
IWA 23:2016(E)
ISO 2016
---------------------- Page: 1 ----------------------
IWA 23:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland

All rights reserved. Unless otherwise specified, 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

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copyright@iso.org
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ii © ISO 2016 – All rights reserved
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IWA 23:2016(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Terms and definitions ..................................................................................................................................................................................... 1

3 Geometrical pitch specifications ......................................................................................................................................................... 3

3.1 General ........................................................................................................................................................................................................... 3

3.2 Geometrical specifications on pitch dimensions ....................................................................................................... 4

4 Device classification .......................................................................................................................................................................................... 5

4.1 General ........................................................................................................................................................................................................... 5

4.2 Initial device classification............................................................................................................................................................ 5

5 Potential future work ...................................................................................................................................................................................... 6

Annex A (informative) Workshop resolutions ............................................................................................................................................ 7

Annex B (informative) Workshop contributors ........................................................................................................................................ 9

Bibliography .............................................................................................................................................................................................................................11

© ISO 2016 – All rights reserved iii
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IWA 23:2016(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 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 .

The committee responsible for this document is the ISO/TMB, Technical Management Board.

International Workshop Agreement IWA 23 was approved at a workshop organized by pan European

(ENIAC Joint Undertaking) project MFmanufacturing, in association with Deutsches Institut für

Normung (DIN). The workshop was held in British Standards Institution (BSI), London, United

Kingdom, on 19 April, 2016. The workshop resolutions and contributors are listed in Annexes A and B,

respectively.
iv © ISO 2016 – All rights reserved
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IWA 23:2016(E)
Introduction

Microfluidics technology plays an important role for next generation devices. In the last few decades,

initial R& D investment in academia has led to the generation of a number of spin out companies.

Most of the companies that have flourished are microfluidic foundries or suppliers of microfluidic

components. However, the track record associated with the success of actual application devices

has been disappointing, with only a small handful of products (such as the ink jet printer) reaching

commercial success.

The concern surrounding the lack of commercialization with regards to microfluidic devices has been

discussed amongst various interested parties and stakeholders within the Microfluidics Consortium

(MC). MC is an ad hoc group that offers a forum for discussion amongst interested parties and

stakeholders in the microfluidics community. Such discussions led to the identification of several factors

that can potentially hinder commercial success of microfluidics devices. This includes the high R&D and

manufacturing costs of devices currently sold into a relatively small market [13]. It has been recognized

that in order to reduce costs, there is a need to bring manufacturing of microfluidic devices to the same

level of maturity and industrialization as electronic devices. This meant the need to mimic some of

the standardization initiatives and outputs from the electronic industry in order to not only reduce

costs but at the same time increase interoperability, thus promoting plug-and-play. The standardization

initiative that had begun in the MC led to the development of several internal documents, such as a

guideline on how to design microfluidic devices [14]. The standardization initiative and knowledge base

gained through the MC eventually led to the formation of a pan-European project MFmanufacturing

consisting of 20 project partners.

In identifying what standards should be proposed, consideration must be given to current market

needs and trends. This led MFmanufacturing to develop, implement and analyse a survey (of 134

respondents), in order to identify those items that are in need of standardization to ultimately enhance

the commercialization of microfluidic devices. Attention was given to those items that have been

identified as being of highest priority, which are
a) terminology of relevance,
b) geometrical specifications on pitch dimensions,
c) device classification.
These items are further discussed in the relevant paragraphs below.
© ISO 2016 – All rights reserved v
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International Workshop Agreement IWA 23:2016(E)
Interoperability of microfluidic devices — Guidelines for
pitch spacing dimensions and initial device classification
1 Scope

This International Workshop Agreement is a consensus document developed by the workshop

participants and observers in response to the need for standardization and harmonization of pitch

spacing dimension, initial device classification and terminology of relevance.

This International Workshop Agreement will serve as a guideline and is applicable to various interested

parties and stakeholders in the microfluidics community.
This International Workshop Agreement

— specifies geometrical standards in relation to pitch connector dimensions of microfluidic devices,

— specifies an initial device classification rules, and
— defines terms of relevance.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
classification
method of sorting into categories
[SOURCE: ISO 22935-1:2009, 3.7]
2.2
connector
component that allows one part of the set to be connected to another
[SOURCE: ISO 3826-4:2015, 3.4]
2.3
device
component or assembly of components to perform a required function
[SOURCE: ISO 10209:2012, 2.30, modified]
2.4
end-users

person or persons who will ultimately be using the system for its intended purpose

[SOURCE: ISO/IEC 19770-5:2015, 3.13]
2.5
integration

process of physically and functionally combining lower-level functional elements (hardware or

software) to obtain a particular functional configuration considered to be of a much higher-level entity

[SOURCE: ISO 10795:2011, 1.117, modified]
© ISO 2016 – All rights reserved 1
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IWA 23:2016(E)
2.6
interconnect
device used to connect two things together
2.7
interested party and stakeholders

person or organization that can affect, be affected by or perceive themselves to be affected by a decision

or activity
[SOURCE: ISO 28007-1:2015, 3.6]
2.8
interoperability

characteristic of providing an intended function in coordination with other components, the

characteristic of sharing information with other system functions or components to provide additional

functionality
[SOURCE: ISO 22902-1:2006, 3.1.42]
2.9
microfluidics

handling of fluids in technical apparatus having internal dimensions in the range of micrometres up to

a few millimetres
[SOURCE: ISO 10991:2009, 2.5, modified]
2.10
miniaturization
making things on a smaller or miniature scale
2.11
pitch

mean distance between corresponding features in a regular array of features on a surface

[SOURCE: ISO 18115-2:2013, 5.106]
2.12
plug and play

denoting or relating to software or devices that are intended to work perfectly when first used

or connected, without reconfiguration or adjustment by the user and thereby enable automatic

configuration
[SOURCE: ISO/IEC/IEEE 21451-4:2010, 3.1.31, modified]
2.13
reliability
capability of a device to function without a failure in all specified conditions
[SOURCE: ISO 16972:2010, 3.158]
2.14
verification

confirmation, through the provision of objective evidence, that specified requirements have been

fulfilled
[SOURCE: ISO 14025:2006, 3.9]
2 © ISO 2016 – All rights reserved
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IWA 23:2016(E)
3 Geometrical pitch specifications
3.1 General

One of the main outputs of the survey is to address the need for geometrical specifications associated

with connectors that will ultimately support an increasing trend towards highly integrated complex

devices (that may require connections to electrical or optical elements) and miniaturization [15].

Interestingly, this output from the MFmanufacturing survey coincided with the result of an earlier

finding from a survey conducted by Semiconductor Equipment and Materials International (SEMI). The

SEMI survey (of 85 respondents) also concluded the need for industry to cater for complex and highly

integrated devices. It is important to highlight that although the two surveys have reached the same

conclusion, the SEMI survey focused on Micro- Electro- Mechanical Systems (MEMS)/sensors rather

than microfluidics [16].

In order to support the drive towards highly integrated complex microfluidic based devices, geometrical

specifications associated with pitch positions must be considered. Much of the early discussions within

MFmanufacturing started in evaluating what has been done with regards to this. Figure 1 summarizes

potential possibilities in relation to port pitch spacing dimensions.
Dimensions in millimetres
Figure 1 — Port pitch dimension possibilities

Figure 1 clearly shows for the purpose of integration and miniaturization, the trend towards smaller

pitches must be realized. In further defining the geometrical specifications for pitch, several factors

must be taken into consideration to include the need to:

a) adapt to what the majority of microfluidic manufacturers and users are currently using, such as

existing standards already found in laboratory equipment [17];

b) have a reliable leakage-free fluidic connections using the currently available multiport connection

technologies.
© ISO 2016 – All rights reserved 3
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IWA 23:2016(E)
3.2 Geometrical specifications on pitch dimensions

The purpose of this Clause is to specify the geometrical connector pitch dimensions for microfluidic

devices.

Designs of microfluidic devices shall be based on a metric multiple pitch concept of n × 1,5 mm, where

n ≥ 1. An example layout for the n × 1,5 mm grid is shown in Figure 2.
Dimensions in millimetres
Key
1 referen
...

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