Laboratory

Laboratory

As a manufacturer of medical devices, Margomed focuses on conducting tests as part of its manufacturing control. The testing laboratory operates in accordance with the EN ISO 13485:2016/A11:2021 Quality Management System. All tests and measurements are carried out under controlled conditions (ISO 8 cleanliness class) and based on applicable standards, relevant technical specifications, or other requirements as requested by the customer.

 

We offer laboratory services in the following areas:

  • Sterility testing
  • Microbiological purity testing (bioburden)
  • Aging tests in a climatic chamber
  • Environmental testing – analysis of particulate and microbiological contamination, as well as surface microbiological contamination using contact plates
  • Physicochemical testing
  • Material strength testing – including tensile, compression, torsion, and bending strength measurements
  • Other tests upon client request

Due to the medical nature of our company, our laboratory is specialized in testing:

  • Medical devices, in accordance with relevant normative requirements
  • Packaging intended for sterilization
  • Clean-room environments, assessing air and surface cleanliness

Our testing services include:

Biological Testing

  • Sterility testing using the direct immersion and membrane filtration methods – in compliance with PN–EN ISO 11737–2:2020
  • Bioburden testing – determination of the microbiological contamination level in accordance with PN–EN ISO 11737–1:2018
  • Evaluation of sterilization effectiveness for medical devices sterilized with ethylene oxide, in accordance with PN–EN ISO 11135:2014-08 and PN–EN ISO 11138–1:2017
  • Environmental cleanliness testing for microbiological contamination in accordance with PN–EN ISO 17141:2021, and for particulate contamination in accordance with PN–EN ISO 14644–1:2016

Physicochemical Testing

UV-VIS Spectrophotometer Analysis

  • We use a UV-VIS Spectrophotometer (200–800 nm) — an indispensable tool in modern laboratories.
    Our testing scope includes quantitative and qualitative analysis of chemical solutions and pure substances, as well as characterization of materials through UV-VIS spectral analysis.

Material Characteristics Testing Using a Universal Testing Machine

  • Our universal testing machine is primarily used to evaluate the mechanical strength of plastic and metal materials.
    Depending on client requirements, we perform compression, bending, and tensile strength tests to determine material performance under various loads.

Aging Tests in a Climatic Chamber

  • We operate a climatic chamber that enables reliable stability testing and precise maintenance of constant climatic conditions.
    The Peltier technology used in the chamber ensures both high temperature and humidity control accuracy and significant energy efficiency compared to traditional systems.
  • The climatic chamber is an essential laboratory device used to accelerate the aging process of various material samples.
    It allows for the simulation of extreme environmental conditions (temperature, humidity) in a controlled environment,
    helping to predict material behavior under specific climatic changes.
  • Optimizing test procedures with the use of climatic chambers ensures product reliability and compliance before market introduction.