For precision in sterility and bioburden
Sterility and bioburden
We’ve developed UKAS accredited analytical methods which are based on the Sterilisation of Healthcare Products: ISO 11737-1:2018/Amd 1:2021 for bioburden testing, and BS EN ISO 11737-2:2019 for sterility testing. This helps make sure contamination risks are reduced and managed on medical devices and that patient safety is ensured in healthcare settings.
Why choose Normec?
UKAS-accredited methods aligned with ISO 11737-1:2018/Amd 1:2021 and BS EN ISO 11737-2:2019 standards
Clear, quantifiable bioburden results and sterility data
Support for both routine and qualification testing
Steam purity testing available in line with HTM 01-01 specs
Our sterility and bioburden testing is an extension to our medical device analytical capability. Both methods are UKAS-accredited
What is Sterility and bioburden testing?
Sterility testing is a quality control process used in healthcare settings to verify the efficacy of cleaning processes, ensuring the introduction of contaminants is prevented and contamination risks reduced.
Bioburden testing is similar to sterility, however, instead it identifies and quantifies viable microorganisms on a medical device before it is sterilised.
Sterility and bioburden testing
We’ve developed analytical methods aligned with:
ISO 11737-1:2018/Amd 1:2021 - Bioburden testing
BS EN ISO 11737-2:2019 - Sterility testing
Bioburden testing quantifies viable microorganisms on devices prior to sterilisation (incubation at 35°C for 72 hours). Sterility testing confirms the absence of microbial growth post-sterilisation.
We also offer steam sterility testing, ensuring the steam used meets HTM 01-01 Part C Table 5 requirements. This includes:
Bacterial endotoxin analysis (<0.25 EU/mL)
Chemistry suite testing (CFPPST)
These services help assess steam quality for both operational and performance qualification, supporting the longevity of the steriliser and safety of the final product.
Accreditations & Recognitions
We go for quality. For guaranteed results.
At Normec Latis Scientific, we uphold the highest standards of quality, safety, and environmental responsibility. We are certified for: - ISO 9001 – Quality Management Systems - ISO 14001 – Environmental Management Systems - ISO 45001 – Occupational Health and Safety Management Systems These certifications demonstrate our commitment to delivering reliable, safe, and sustainable services, while continuously improving our processes and protecting people and the environment. Proficiency Testing Proficiency testing is central to our quality system and provides confidence that our methods, equipment and staff are delivering the levels of quality required by UKAS and our clients. Normec Latis Scientific participates in external proficiency testing schemes provided by Public Health England and FAPAS.
UKAS schedule of accreditation
Our laboratories are accredited by the United Kingdom Accreditation Service (UKAS) to the norm ISO/IEC 17025:2017, the British, European and International Standard for quality assurance in analytical laboratories. The full standard covers quality assurance and method specific procedures, with all individual methods inspected and approved by UKAS. Normec Latis Scientific Limited, a UKAS accredited testing laboratory No. 2279.
Legionella Control Association
Latis Scientific hold the LCA Certificate of Registration issued by the Legionella Control Association (LCA).
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Normec Latis Scientific
London United Kingdom