ISO 16189:2021 PDF

Overview

ISO 16189:2021 is an international standard published by the International Organization for Standardization (ISO) that specifies a test method for quantitative determination of dimethylformamide (DMF) in footwear and footwear components. This method focuses on materials containing polyurethane (PU) coatings, where DMF may be present due to its use in the coating process. The standard provides a scientifically validated procedure using gas chromatography coupled with mass selective detection (GC-MS) to ensure accurate detection and measurement of DMF in footwear materials.

The presence of DMF in footwear components is a critical safety concern due to its potential health risks. Therefore, ISO 16189:2021 supports manufacturers, testing labs, and regulatory bodies in monitoring and controlling DMF content to meet safety and compliance requirements.

Key Topics

• Scope: The standard applies specifically to PU coated footwear materials, where DMF might be used during manufacturing. It excludes PU injected or reaction-moulded processes that do not require DMF.
• Sample Preparation: Small pieces (3-5 mm) of the PU coated material are cut and extracted in methanol at 70 °C for 1 hour using an ultrasonic bath.
• Analytical Technique: DMF quantification is performed via gas chromatography-mass spectrometry (GC-MS), utilizing an internal standard and calibration curve for precise measurement.
• Reagents and Apparatus: Detailed specification of reagents includes analytical-grade DMF, DMF-d7 (internal standard), and methanol. Laboratory apparatus such as ultrasonic baths, precision balances, PTFE filters, and GC-MS equipment are also specified.
• Calibration and Reporting: The method outlines preparation of calibration solutions, instrumental settings, expression of results as mg/kg in the sample, and comprehensive test report requirements aligned with ISO practices.
• Performance: ISO 16189:2021 achieves a limit of quantification (LOQ) of 5 mg/kg or lower for DMF detection, offering reliable sensitivity.

Applications

• Footwear Quality Control: Footwear manufacturers incorporate ISO 16189:2021 to monitor and control DMF residues in PU coated materials, helping to reduce chemical exposure risks.
• Regulatory Compliance: Testing labs and inspection agencies use this standard to verify that footwear products comply with health and safety regulations regarding hazardous substances.
• Material Safety Assessment: The standard assists in assessing chemical safety during product development or supplier audits, ensuring safer consumer products.
• Research and Development: R&D teams can apply the quantitative DMF detection method for material innovation while controlling critical substances in footwear components.

Related Standards

• ISO/TR 16178:2021 – Provides a list of critical chemical substances relevant to footwear and identifies materials subject to DMF determination.
• ISO 21061 – Covers general principles on chemical testing and sample preparation for footwear.
• EN 17131 and EN 16778 – European standards related to the determination of DMF in textiles and protective gloves using gas chromatography methods.
• ISO 3696 – Specifies quality and testing protocols for water used in analytical laboratory settings.
• ISO 4787 – Defines requirements for volumetric laboratory glassware used during testing procedures.

This standard is essential for manufacturers and laboratories involved in footwear production, ensuring consumer safety by effectively managing critical chemical substances like dimethylformamide through standardized, accurate testing methods. For further information, visit ISO.org.