Laboratory testing services

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SEM-EDX imaging

Imaging of the sample using a scanning electron microscope (SEM) with energy-dispersive X-ray spectroscopy (EDX or EDS). Typically, several images are taken with varying magnifications to get a good overview of the sample. An EDX mapping, line scan, or point measurement is …

SEM imaging

Imaging of the sample using scanning electron microscopy (SEM). Typically, several images are taken with varying magnifications to get a good overview of the sample. Non-conductive samples can be prepared with a metallic coating to allow imaging. For cross-section measurement, …

Biological Evaluation Plan (BEP)

ISO 10993-1
WHAT is a Biological Evaluation Plan? A Biological Evaluation Plan (BEP) is a critical part of assessing the safety of a medical device. It involves a detailed examination of various aspects such as the device's design & …

Face mask tests according to EN 14683 for type II and type IIR masks

EN 14683, ISO 10993-10, ISO 10993-5, …
We offer comprehensive test packages for verifying the quality of type II and type IIR face masks according to the EN …

TEM imaging

Imaging of the sample with transmission electron microscope (TEM). Typically, several images with varying magnifications are taken to get a good overview of the sample. TEM allows nm-resolution images. Solid samples often require FIB preparation, which is not included in the price. …

Chemical characterization of medical devices by ISO 10993-18

ISO 10993-18
Chemical characterization by the ISO 10993-18 standard is performed to identify the constituents of a medical device and to estimate and control the risks associated with its chemical …

Bioburden testing by ISO 11737-1, aerobic & anaerobic bacteria and fungi

ISO 11737-1
The term bioburden describes the presence of microorganisms on a product, raw material, or surface. Bioburden testing plays a crucial role in the quality control of …

Sterility test by ISO 11737-2: Aerobic bacteria, anaerobic bacteria and fungi

ISO 11737-2
Sterility testing measures the growth of microorganisms on a product after the product has been sterilized. ISO 11737-2 is a harmonized standard for evaluating …

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Distribution testing of shipping containers and systems by ASTM D4169

ASTM D4169
ASTM D4169 is widely used in various industries, including packaging, logistics, and transportation, to assess the ability of shipping containers and packaging systems to …

Accelerated aging of medical device sterile barrier systems by ASTM F1980

ASTM F1980
ASTM F1980 establishes a standardized approach for accelerated aging testing of medical device sterile barrier systems (SBS), either with or without devices. These …

Wound dressing test methods (EN 13726)

EN 13726
Wound dressings are applied to open wounds acquired through trauma or surgery to absorb excess wound exudate, and to protect the wound from further mechanical damage and infection. Appropriate testing of different types of …

Biocompatibility evaluation of breathing gas pathways by ISO 18562

ISO 18562-2, ISO 18562-3
The biocompatibility of medical devices with breathing gas pathways is generally assessed according to ISO 18562 standards. Measurlabs offers tests …

Biocompatibility testing by the ISO 10993 standard family

ISO 10993-1
The biocompatibility of medical devices is generally assessed according to ISO 10993 standards. Measurlabs offers a wide range of tests by the standard family, including the following: - …

Cytotoxicity testing by ISO 10993-5

ISO 10993-5
Cytotoxicity assessment is a crucial part of biocompatibility testing, which ensures that medical devices do not cause adverse reactions when in contact with the body. The assessment is required for new medical devices to be …

Microbial barrier testing by ASTM F1608

ASTM F1608
The ASTM F1608 method is used to determine the passage of airborne bacteria through porous materials used in the packaging of sterile medical devices. With the test, different materials can be compared to determine which …

Skin irritation testing by ISO 10993-23

ISO 10993-23
ISO 10993-23 tests for irritation encompass a range of testing options for assessing the impacts of medical devices on the patient's tissues. Tests can be performed in vitro or in vivo, depending on the requirements …

Skin sensitization testing by ISO 10993-10

ISO 10993-10
Skin sensitization testing by the ISO 10993-10 standard is a key part of assessing the biocompatibility of medical devices. Testing is required for all medical devices that come into contact with the human body …

Systemic toxicity studies for medical devices by ISO 10993-11

ISO 10993-11
As part of a medical device's biocompatibility evaluation, systemic toxicity tests following ISO 10993-11 are used to assess the risk of the device or its components causing harmful …

Toxicological risk assessment of medical devices by ISO 10993-17

ISO 10993-17
Toxicological risk assessment by the ISO 10993-17 standard is essential for determining the biocompatibility of a medical device. After chemical characterization (ISO 10993-18) is …

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