EN ISO 16189:2021

Footwear - Critical substances potentially present in footwear and footwear components - Test method to quantitatively determine dimethylformamide in footwear materials (ISO 16189:2021)

This document specifies a method to determine the amounts of dimethylformamide (DMF) in footwear and footwear components containing polyurethane (PU) coated material.
NOTE 1   In the footwear industry, when PU is injected (reaction moulded), this process does not require the use of DMF. For PU coated material, the use of DMF is possible.
NOTE 2   Several abbreviations can be used for dimethylformamide DMF, DMFa, DMFo. This document uses DMF.
ISO/TR 16178:2021, Table 1 defines which materials are concerned by this determination.

Schuhe - Möglicherweise in Schuhen und Schuhbestandteilen vorhandene kritische Substanzen - Prüfverfahren zur quantitativen Bestimmung von Dimethylformamid in Schuhwerkstoffen (ISO 16189:2021)

Dieses Dokument legt ein Verfahren zur quantitativen Bestimmung von Dimethylformamid (DMF) in Schuhen und Schuhbestandteilen fest, die mit Polyurethan (PU) beschichtetes Material enthalten.
ANMERKUNG 1 In der Schuhindustrie ist für diesen Prozess, bei dem PU eingespritzt wird (RIM-Verfahren), die Verwendung von DMF nicht erforderlich. Für PU-beschichtetes Material ist die Verwendung von DMF möglich.
ANMERKUNG 2 Für Dimethylformamid DMF, DMFa, DMFo können mehrere Abkürzungen verwendet werden. Dieses Dokument verwendet DMF.
ISO/TR 16178:2021, Tabelle 1, legt fest, welche Materialien von dieser Bestimmung betroffen sind.

Chaussures - Substances critiques potentiellement présentes dans les chaussures et les composants de chaussures - Méthode d’essai pour déterminer quantitativement le diméthylformamide dans les matériaux de chaussures (ISO 16189:2021)

Le présent document spécifie une méthode pour déterminer la quantité de diméthylformamide (DMF) dans les chaussures et les composants de chaussures contenant un matériau enduit de polyuréthane (PU).
NOTE 1   Dans l’industrie de la chaussure, lorsque du PU est injecté (moulage par réaction), ce procédé ne nécessite pas l’emploi de DMF. Pour les matériaux enduits de PU, l’utilisation de DMF est possible.
NOTE 2   Plusieurs abréviations peuvent être utilisées pour désigner le diméthylformamide: DMF, DMFa, DMFo. Le présent document utilise l’abréviation DMF.
Le Tableau 1 de l’ISO/TR 16178:2021 définit les matériaux qui sont concernés par cette détermination.

Obutev - Kritične snovi, ki so lahko v obutvi in delih obutve - Preskusna metoda za kvantitativno ugotavljanje dimetilformamida v obutvenih materialih (ISO 16189:2021)

Ta dokument določa metodo za ugotavljanje količine dimetilformamida (DMF) v obutvi in delih obutve, ki vsebujejo material, prevlečen s poliuretanom (PU). OPOMBA 1: Postopek vbrizgavanja poliuretana v obutveni industriji (reakcijsko brizganje) ne zahteva uporabe dimetilformamida. Za material, prevlečen s poliuretanom, je uporaba dimetilformamida mogoča. OPOMBA 2: Za dimetilformamid je mogoče uporabiti različne kratice: DMF, DMFa, DMFo. V tem dokumentu se uporablja kratica DMF. V preglednici 1 standarda ISO/TR 16178:2021 so opredeljeni materiali, ki jih zadeva ta določitev.

General Information

• Status: Published
• Publication Date: 07-Dec-2021
• Withdrawal Date: 29-Jun-2022
• ICS: 61.060 - Footwear
• Technical Committee: CEN/TC 309 - Footwear
• Drafting Committee: CEN/TC 309/WG 2 - Footwear and environmental aspects
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 08-Dec-2021
• Completion Date: 08-Dec-2021
• Ref Project: SIST EN ISO 16189:2022 - Footwear - Critical substances potentially present in footwear and footwear components - Test method to quantitatively determine dimethylformamide in footwear materials (ISO 16189:2021)

Relations

• Replaces: CEN ISO/TS 16189:2013 - Footwear - Critical substances potentially present in footwear and footwear components - Test method to quantitatively determine dimethylformamide in footwear materials (ISO/TS 16189:2013)
• Effective Date: 15-Dec-2021

Overview - EN ISO 16189:2021 (ISO 16189:2021) - DMF test method for footwear

EN ISO 16189:2021 specifies a laboratory test method to quantitatively determine dimethylformamide (DMF) in footwear and footwear components made from or containing polyurethane (PU) coated materials. Adopted by CEN as EN ISO 16189:2021, this standard updates and replaces the earlier ISO/TS 16189:2013. It is intended for materials where the use of DMF is possible (PU coated material), noting that reaction‑moulded (injected) PU production typically does not require DMF.

Keywords: EN ISO 16189:2021, ISO 16189:2021, dimethylformamide, DMF, footwear testing, polyurethane coated.

Key topics and technical requirements

• Scope: Quantitative determination of DMF in footwear materials containing PU coating; materials of interest are further defined in ISO/TR 16178:2021.
• Sample preparation:
  • Cut PU coated material into pieces approximately 3–5 mm edge length.
  • Weigh (1.00 ± 0.10) g of sample into a sealed glass vial.
  • Add 1 ml internal standard (DMF‑d7 working solution) and 9 ml methanol.
• Extraction:
  • Extract in an ultrasonic bath at 70 ± 5 °C for 60 ± 5 minutes; cool and filter through a PTFE membrane (0.45 µm) if necessary.
• Analytical determination:
  • Analysis by gas chromatography with mass selective detection (GC‑MS) using an internal standard (DMF‑d7).
  • Calibration: at least four calibration points (example range 0.5–20 mg/l shown in the standard).
  • Results expressed as a mass fraction (mg/kg) using an internal‑standard linear regression calibration.
• Reagents & apparatus: DMF (reference standard), DMF‑d7 internal standard, methanol, amber volumetric glassware (ISO 4787), GC‑MS, ultrasonic bath, PTFE filters and vials. Working and stock solutions stored refrigerated (~4 °C).

Applications and who uses this standard

• Footwear manufacturers: monitor DMF residues in PU coated components to manage product safety and process control.
• Independent testing laboratories: provide accredited screening and quantitative analysis of DMF in shoes, insoles, linings and other footwear parts.
• Material suppliers and quality control teams: verify supplier materials and ensure compliance with buyer specifications or regulatory requirements.
• Regulators and compliance officers: reference a standardized GC‑MS method for enforcement, surveillance and risk assessment related to DMF in consumer footwear.

Practical value: the standard offers a reproducible, validated extraction and GC‑MS workflow for reliable quantification of DMF, enabling consistent reporting (mg/kg) across laboratories.

Related standards

• ISO/TR 16178:2021 - defines materials concerned by this determination.
• ISO 4787 - laboratory glassware and volumetric instruments (referenced for volumetric procedures).
• Supersedes: ISO/TS 16189:2013 (previous technical specification).

For procurement or laboratory implementation search terms: EN ISO 16189:2021, ISO 16189 DMF test method, footwear DMF GC‑MS analysis, polyurethane coated footwear testing.

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2022
Nadomešča:
SIST-TS CEN ISO/TS 16189:2014
Obutev - Kritične snovi, ki so lahko v obutvi in delih obutve - Preskusna metoda za
kvantitativno ugotavljanje dimetilformamida v obutvenih materialih (ISO
16189:2021)
Footwear - Critical substances potentially present in footwear and footwear components
- Test method to quantitatively determine dimethylformamide in footwear materials (ISO
16189:2021)
Schuhe - Möglicherweise in Schuhen und Schuhbestandteilen vorhandene kritische
Substanzen - Prüfverfahren zur quantitativen Bestimmung von Dimethylformamid in
Schuhwerkstoffen (ISO 16189:2021)
Chaussures - Substances critiques potentiellement présentes dans les chaussures et les
composants de chaussures - Méthode d’essai pour déterminer quantitativement le
diméthylformamide dans les matériaux de chaussures (ISO 16189:2021)
Ta slovenski standard je istoveten z: EN ISO 16189:2021
ICS:
61.060 Obuvala Footwear
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 16189
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2021
EUROPÄISCHE NORM
ICS 61.060 Supersedes CEN ISO/TS 16189:2013
English Version
Footwear - Critical substances potentially present in
footwear and footwear components - Test method to
quantitatively determine dimethylformamide in footwear
materials (ISO 16189:2021)
Chaussures - Substances critiques potentiellement Schuhe - Möglicherweise in Schuhen und
présentes dans les chaussures et les composants de Schuhbestandteilen vorhandene kritische Substanzen -
chaussures - Méthode d'essai pour déterminer Prüfverfahren zur quantitativen Bestimmung von
quantitativement le diméthylformamide dans les Dimethylformamid in Schuhwerkstoffen (ISO
matériaux de chaussures (ISO 16189:2021) 16189:2021)
This European Standard was approved by CEN on 5 November 2021.

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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16189:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 16189:2021) has been prepared by Technical Committee ISO/TC 216
"Footwear" in collaboration with Technical Committee CEN/TC 309 “Footwear” the secretariat of which
is held by UNE.
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 2022, and conflicting national standards shall be
withdrawn at the latest by June 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 CEN ISO/TS 16189:2013.
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 16189:2021 has been approved by CEN as EN ISO 16189:2021 without any modification.

INTERNATIONAL ISO
STANDARD 16189
Second edition
2021-11
Footwear — Critical substances
potentially present in footwear
and footwear components — Test
method to quantitatively determine
dimethylformamide in footwear
materials
Chaussures — Substances critiques potentiellement présentes dans
les chaussures et les composants de chaussures — Méthode d’essai
pour déterminer quantitativement le diméthylformamide dans les
matériaux de chaussures
Reference number
ISO 16189:2021(E)
ISO 16189:2021(E)
© ISO 2021
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 16189:2021(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 1
5 Reagents . 1
6 Apparatus . 2
7 Preparation of sample . 3
7.1 Sampling . 3
7.2 Extraction . 3
8 Determination with GC-MS . 3
8.1 Calibration standard . 3
8.2 Examples of instrumental method . 3
9 Expression of results - Calibration curve . 4
10 Performance of the method . 4
11 Test report . 4
Annex A (informative) Suggested parameters for GC-MS determination of DMF .5
Bibliography . 6
iii
ISO 16189:2021(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
...