Ensuring the safety of medical devices
Patient safety starts with effective control of microbiological risks. That is why it is essential to understand the presence of microorganisms on medical devices, both before and after sterilisation.
Sterility and bioburden testing provides valuable insight into the effectiveness of cleaning and sterilisation processes, helping you demonstrate that your products meet applicable quality and safety requirements.
Assessing microbial contamination and sterilisation performance
Sterility and bioburden testing complement one another. While a sterility test confirms that a product is free from microbial growth after sterilisation, a bioburden test determines the number of viable microorganisms present before the sterilisation process.
Together, these results provide an essential foundation for process validation, quality control and risk management in the manufacture of medical devices.
Accredited testing in accordance with ISO 11737
Normec performs sterility and bioburden testing in accordance with internationally recognised standards, including:
- ISO 11737-1:2018/Amd 1:2021 for bioburden testing
- BS EN ISO 11737-2:2019 for sterility testing
During bioburden testing, viable microorganisms present on medical devices are quantified before sterilisation. Sterility testing verifies whether any microbial growth remains after sterilisation.
We also provide steam quality testing in accordance with HTM 01-01 Part C Table 5, including:
- Bacterial endotoxin analysis (<0.25 EU/mL)
- Chemical analysis (CFPPST)
With our support, you can:
- Obtain reliable data on microbiological safety
- Demonstrate compliance with relevant ISO standards for sterility and bioburden testing
- Support process validation and quality assurance with objective test results
- Gain insight into the quality of sterilisation steam
- Strengthen evidence of product safety and regulatory compliance
Expertise in microbiological testing
Our sterility and bioburden testing services form part of Normec's comprehensive analytical offering for the medical device industry. Through our accredited laboratories and experienced microbiology specialists, we deliver reliable results for both routine quality control and qualification studies.
We support manufacturers, healthcare organisations and validation specialists with accurate testing and clear, comprehensive reporting.
Supporting increasingly stringent quality requirements
Requirements for microbiological safety and product quality continue to become more demanding. Regular sterility and bioburden testing helps you demonstrate that your processes remain under control while identifying potential risks at an early stage.
Normec is your trusted partner for continuous quality improvement, regulatory compliance and patient safety.
Would you like to know more about sterility and bioburden testing?
Frequently Asked Questions
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A bioburden test determines the number of viable microorganisms present on a medical device before sterilisation.
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A sterility test verifies that a product is free from microbial growth after sterilisation.
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We perform bioburden testing according to ISO 11737-1:2018/Amd 1:2021 and sterility testing according to BS EN ISO 11737-2:2019.
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These tests help control microbiological risks, demonstrate product safety and support compliance with quality and regulatory requirements.
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Steam quality testing assesses whether the steam used in sterilisation processes meets the required quality standards.
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Bacterial endotoxins are substances produced by certain bacteria that can trigger harmful biological reactions. They are therefore monitored as part of steam quality testing.
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Yes. We support both routine quality control programmes and validation and qualification studies.