Laboratory testing services

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, …

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 & structure, its material composition, …

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 before analysis. HR-TEM can also be …

We offer comprehensive test packages for verifying the quality of type II and type IIR face masks according to the EN …

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 …

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 medical devices, …

Bacterial endotoxin tests, also known as Limulus Amebocyte Lysate (LAL) tests, are used to detect endotoxins in pharmaceuticals to evaluate the pyrogenic …

The bacterial reverse mutation (AMES) test is used to evaluate the genotoxic effect of a medical device or its extract when in contact with a bacterial suspension. The test is …

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

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 …

A biological evaluation report (BER) or biological risk assessment report (BRA) collects and evaluates the results of biological evaluation studies and concludes the medical device's biological risk. It is a comprehensive …

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

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

Sterilization residue testing according to ISO 10993-7 is a crucial part of the biocompatibility assessment for medical devices that have been sterilized with …

The purpose of cleaning validation studies is to show that reusable medical devices can be reprocessed effectively between uses so that patients are …

Cyclosiloxanes are the primary building blocks of siloxane polymers and, ultimately, silicone rubber. Hence, cyclosiloxanes can remain in the final silicone article as residual impurities. Several cyclosiloxanes (D4, D5, D6; see table below) are considered harmful …

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 …

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 …

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

The ISO 11737-3 standard provides internationally recognized guidelines for bacterial endotoxin testing of medical devices. Tests described in the standard can be used to evaluate the pyrogenic potential of medical …

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 …

Hemocompatibility testing is performed to evaluate the interaction between a medical device or material and blood. The goal is to ensure that the device does not cause adverse effects, such as …

ISO 10993-23 is an internationally recognized standard for assessing the irritation potential of medical devices when they come into contact with skin, mucosal membranes, or subcutaneous tissues. Irritation tests performed …

IEC 60601-1 is a widely accepted benchmark standard that defines the general requirements for the safety of medical electrical equipment, particularly addressing the …

Pyrogenicity assessment by ISO 10993-11 to evaluate the material-mediated pyrogenic (i.e., fever-inducing) potential of medical devices. Material-mediated pyrogenicity tests focus on non-endotoxin-related substances, …

Sensitization assessment by ISO 10993-10 is a crucial part of biocompatibility testing and one of the most common tests required to ensure the safety and compliance of medical devices. The goal is to show that …