The latest edition of ISO 10993-1:2025 introduces important updates to the biological evaluation of medical devices, strengthening integration with ISO 14971 and introducing revised contact categorisation and biological effects.

Biocompatibility is essential to medical device safety, compliance, and global market approval. Guided by ISO 10993 and ISO 14971, it ensures devices perform without harming patients while meeting evolving regulatory standards. Regular updates and risk-based strategies are key to maintaining…

ISO 10993 and ISO 18562 are complementary biocompatibility standards used to evaluate medical device safety. ISO 10993 focuses on biological risks from materials in contact with tissue, while ISO 18562 addresses inhalation risks from devices delivering breathing gases. Knowing which…

A personal reflection on how biological evaluation shaped the author’s life, from life-saving but imperfect neonatal blood bags to growth-hormone therapies and early medical devices, and how these experiences now inform a human-centred approach to designing safer, smarter medical technologies…

ISO 10993-12:2021 is a critical but often overlooked standard that defines how medical devices must be prepared and extracted before biocompatibility testing. Proper sample preparation ensures accurate, clinically relevant results and prevents regulatory setbacks caused by false positives, missed risks,…

Medical device lifecycle testing is essential for regulatory approval, especially for reusable instruments subject to repeated sterilisation. Benchtop autoclaves, when combined with sensors and dataloggers, can speed up testing cycles and improve data accuracy, helping smaller labs deliver rapid, reliable…

At Test Labs we validate cleaning, disinfection, and sterilisation of reusable medical devices to ensure safety, regulatory compliance, and durability. Our insights help medical device manufacturers produce devices that are effective, reliably reprocessable, and sustainable.

The importance of validating cleaning, disinfection, and sterilisation instructions for reusable medical devices and highlights of how ISO 17664 compliance protects patients and supports manufacturers in meeting regulatory requirements.

Integrated electronic traceability is transforming medical device reprocessing by unifying fragmented systems into a single, data-driven ecosystem. This shift enables real-time visibility, improved patient safety, operational efficiency, and measurable sustainability across healthcare workflows.

Incompatibility between disinfectants and device materials results in equipment damage and higher HAI rates. Understanding and addressing root causes is essential.

Mechanical degradation caused by repeated medical device reprocessing can lead to fatigue, cracking, surface wear, and loss of function. Understanding these risks, and validating durability through service-life testing is essential for safe reuse and regulatory compliance.

Quality testing in medical devices ensures safety, compliance, and performance from concept to market. By verifying material integrity, chemical safety, and mechanical strength, it prevents failures and builds confidence in device reliability. It’s a strategic investment that protects patients, reputation,…

Material compatibility testing ensures medical devices maintain safety and performance throughout cleaning, sterilisation, and use. It helps manufacturers choose appropriate materials and reprocessing methods.

BS 8628:2022 establishes a standardised method for testing and validating the performance of automated UV surface disinfection systems. It enables consistent, science-based comparison of UV technologies across healthcare, pharmaceutical, and other high-risk environments.

BS EN 17272 standardises how airborne room disinfection systems are tested, enabling measurable, repeatable validation of whole-room microbial efficacy.

Manual disinfection is essential for heat-sensitive reusable medical devices that can’t undergo sterilisation. Breaking down when, why, and how manual disinfection is used, including regulatory standards, Spalding classification, and critical process controls that medtech leaders must know to stay compliant…

While Good Laboratory Practice principles were originally intended for non-clinical studies in the chemical and pharmaceutical sectors, their scope has expanded to other industries, such as medical devices.

Medical device and IVD safety relies on IEC 60601-1 and IEC 61010-1 standards. Understanding MOPP, MOOP and clearances is critical for risk management and regulatory compliance. These standards guide manufacturers in delivering safe, compliant and reliable products.