EN 16778:2016

Protective gloves - The determination of Dimethylformamide in gloves

This document specifies a test method for the determination of Dimethylformamide (DMFa – CAS N° 68-12-2) in glove materials.
NOTE   For Dimethylformamide the following abbreviations can be used: DMF, DMFa DMFo.
The test method is applicable for the following materials:
-   polyurethane (PU) materials (except elastane), PU Coated material (textile, leather), PU foam, PU blended materials;
-   adhesives;
-   all materials manufactured with a dipping process using DMFa.

Schutzhandschuhe - Bestimmung von Dimethylformamid in Handschuhen

Dieses Prüfverfahren legt die Bestimmung von Dimethylformamid (DMFa - CAS N° 68 12 2) in Handschuh-materialen fest.
ANMERKUNG 1   Für Dimethylformamid können die folgenden Abkürzungen verwendet werden: DMF, DMFa, DMFo.
ANMERKUNG 2   Die folgenden Materialien werden behandelt:
-   Materialien aus Polyurethan (PU), PU-beschichtetes Material (Textil, Leder), Polyurethanschaum;
-   Klebemittel;
-   alle Materialien, die mit einem Tauchverfahren hergestellt werden, das DMFa2 verwendet.
ANMERKUNG 3   Elastan enthaltende Materialien sind nicht Gegenstand der vorliegenden Norm.

Gants de protection - Détermination de la teneur en diméthylformamide dans les gants

Le présent document spécifie une méthode d’essai pour déterminer la teneur en diméthylformamide (DMFa – N° CAS 68-12-2) dans les gants.
NOTE   Les abréviations suivantes peuvent être utilisées pour le diméthylformamide : DMF, DMFa, DMFo.
La méthode d'essai est applicable aux matériaux suivants :
—   le polyuréthanne (PU) (à l'exception de l'élasthanne), les matériaux enduits de polyuréthanne (textile, cuir), la mousse de polyuréthanne, les mélanges de matériaux contenant du polyuréthanne ;
—   les adhésifs ;
—   tous les matériaux fabriqués selon un procédé par immersion utilisant du DMFa.

Varovalne rokavice - Ugotavljanje dimetilformamida v rokavicah

Ta preskusna metoda določa način ugotavljanja dimetilformamida (DMFa – CAS N° 68-12-2) v materialih rokavic. OPOMBA: Za dimetilformamid se lahko uporabljajo kratice DMF, DMFa ali DMFo. OPOMBA: Obravnavani so zlasti naslednji materiali: – poliuretanski (PU) materiali, materiali, prevlečeni s poliuretanom (tekstil, usnje), poliuretanska pena – lepila – vsi materiali, ki so izdelani s postopkom potopitve z uporabo DMFa2 OPOMBA: Materiali, ki vsebujejo elastan, niso obravnavani v tem standardu.

General Information

• Status: Published
• Publication Date: 29-Mar-2016
• Withdrawal Date: 29-Sep-2016
• ICS: 13.340.40 - Hand and arm protection
• Technical Committee: CEN/TC 162 - Protective clothing including hand and arm protection and lifejackets
• Drafting Committee: CEN/TC 162/WG 8 - Protective gloves
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 10-Oct-2025
• Completion Date: 22-Oct-2025
• Directive: 89/686/EEC - Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment
• Mandate: M/031 - Standardization mandate to CEN/CENELEC concerning standards for Personal Protective Equipment
• Ref Project: SIST EN 16778:2016 - Protective gloves - The determination of Dimethylformamide in gloves

Overview

EN 16778:2016 - "Protective gloves - The determination of Dimethylformamide in gloves" (CEN) specifies a laboratory test method to detect and quantify Dimethylformamide (DMFa / DMF) in glove materials. The standard is focused on materials where DMF may be present due to manufacture or processing, notably polyurethane (PU) materials, PU-coated textiles or leather, PU foam, PU blends, adhesives and any materials produced by dipping processes using DMFa.

Keywords: EN 16778:2016, Dimethylformamide, DMF, protective gloves, test method, PU gloves, GC‑MS

Key topics and technical requirements

• Scope and materials: Applicable to PU (except elastane), PU-coated materials, adhesives and dipped goods produced with DMFa.
• Analytical principle: Cut test pieces are extracted with methanol in a sealed flask using an ultrasonic bath (30 min at ~70 °C), followed by filtration and analysis by GC‑MS (SIM/SCAN mode).
• Internal standard: Use of deuterated internal standard DMFa‑d7 to ensure accurate quantification.
• Calibration: Multi‑point calibration (five levels plus blank) prepared in methanol; calibration curve used to calculate sample concentration from GC‑MS peak areas.
• Sample handling: Receive and store samples in airtight plastic bags (no vacuum sealing); if held >24 h, store at (4 ± 3) °C. Condition samples 24 ± 1 h at (23 ± 2) °C before prep. Test pieces are specific (full finger plus palm/back strips) and cut into ~10 × 10 mm pieces.
• Quantification & reporting: Results reported as mass fraction (mg/kg or ppm); method quantification limit (LOQ) is 5 mg/kg DMFa in gloves.
• Equipment & reagents: Analytical balance, PTFE‑sealed flasks, ultrasonic bath, PTFE membrane filters (0.45 µm), GC‑MS, methanol, certified DMFa and DMFa‑d7 standards.

Practical applications and users

• Who uses it:
  • Third‑party testing laboratories performing compliance and safety tests on protective gloves.
  • Glove manufacturers for incoming quality control and supplier verification.
  • PPE procurement and certification bodies assessing chemical safety of gloves.
  • Regulatory agencies and occupational safety teams screening for DMF residues that could pose health risks.
• Why it’s used:
  • Confirm absence or quantify residual DMFa from manufacturing (especially dipping processes).
  • Support product safety documentation, regulatory compliance and supplier audits.
  • Inform material selection and process controls for PU glove production.

Related standards

• CEN reference and bibliography includes CEN ISO/TS 16189 / ISO/TS 16189:2013 (footwear DMF test method), which is relevant where DMF testing across different PPE components is required.

EN 16778:2016 is a practical, instrument‑based standard for reliably detecting residual Dimethylformamide in glove materials using established extraction and GC‑MS quantification procedures.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Varovalne rokavice - Ugotavljanje dimetilformamida v rokavicahSchutzhandschuhe - Bestimmung von Dimethylformamid in HandschuhenGants de protection - Détermination de la teneur en diméthylformamide dans les gantsProtective gloves - The determination of Dimethylformamide in gloves13.340.40Varovanje dlani in rokHand and arm protectionICS:Ta slovenski standard je istoveten z:EN 16778:2016SIST EN 16778:2016en,fr,de01-junij-2016SIST EN 16778:2016SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16778
March
t r s x ICS
s uä u v rä v r English Version
Protective gloves æ The determination of Dimethylformamide in gloves Gants de protection æ Détermination de la teneur en diméthylformamide dans les gants
Schutzhandschuhe æ Bestimmung von Dimethylformamid in Handschuhen This European Standard was approved by CEN on
u r January
t r s xä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels
t r s x CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s x y y zã t r s x ESIST EN 16778:2016

Results of the interlaboratory trial . 10 Bibliography . 11
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