Medical Device Extractables & Leachables

Extractables and Leachables (E&L) Testing

ISO 10993-18

Chemical characterization studies under ISO 10993-18 identify substances that may be released from medical devices. Extractables and leachables (E&L) results are essential inputs for toxicological risk assessment.

Required by FDA, EU MDR and other global regulators
Applies to polymers, coatings, adhesives, colorants, metals, ceramics
Supports overall device risk management

E&L Purpose
E&L Testing Process
Extractables vs Leachables

E&L Purpose

Why characterize chemicals for medical devices?

Ensures compliance with FDA, EU MDR, global regulators
Provides full chemical profile of device materials
Supports toxicological risk assessment and biological evaluation
Covers VVOC, VOC, SVOC, NVOC and elemental impurities

E&L Testing Process

Accredited and GLP-Compliant Testing

Hohenstein is a Good Laboratory Practice-compliant laboratory, certified to perform chemical, physical and biological testing.

Hohenstein applies validated analytical methods to characterize device materials.

Sample preparation (ISO 10993-12)
VOC screening in aqueous extracts (GC-MS)
SVOC screening in aqueous, semi-polar and non-polar extracts (GC-MS)
NVOC screening in aqueous, semi-polar and non-polar extracts (HPLC-qTOF)
Elemental impurity screening in aqueous extracts (ICP-MS)
VVOC and VOC screening by thermal desorption (in emission chamber)

Factsheet - Chemical Characterization - DIN EN ISO 10993-18

Extractables vs Leachables

What is the difference between Extractables & Leachables?

Extractables testing uses strong solvents, elevated temperatures and extended extraction times to create exaggerated, worst-case conditions. These studies:
- Identify and quantify compounds that could potentially extract from a device
- Reveal more compounds than would typically appear under clinical use
Leachables testing uses simulated-use conditions (e.g., artificial urine) to reveal a more realistic patient exposure

Used together with a toxicological risk assessment (TRA), these studies help determine if further safety testing is needed.

Why Hohenstein Medical?

Testing performed in ISO/IEC 17025–accredited, GLP-certified laboratory
Decades of material chemistry and biocompatibility expertise
US-based team with direct coordination to FDA and EU MDR requirements
Integrated support with broader ISO 10993 biological evaluation services
Customized study designs for unique materials, device types and risk profiles

Chemical Characterization of Medical Devices

E&L Purpose

E&L Testing Process

Extractables vs Leachables