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,…

Particulate contamination presents a serious but often overlooked risk to medical device safety, particularly when particles enter the bloodstream. Understanding where particulates originate, how they are extracted and analysed, and which standards define acceptable limits is essential for protecting patients,…

FDA has partially recognised ISO 10993-1:2025, meaning medical device manufacturers can adopt the new standard but must carefully address several key FDA exceptions when preparing biological evaluation submissions.

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.

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…

Service life validation demonstrates that a medical device continues to perform safely and effectively throughout its intended lifespan. It verifies durability under expected use, maintenance, and reprocessing conditions, supporting ISO 14971 compliance and risk management. By replicating real-world stressors, customised…

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.

Retesting is costly and avoidable. This article breaks down the 10 most common IFU mistakes that trigger rework, and how to fix them early.

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.

Reusable medical devices face increased regulatory scrutiny under MDR and FDA expectations, with reprocessing now requiring clear, defensible evidence. Common failures occur in cleaning validation, disinfection efficacy, sterilisation justification, service life testing, and post-reprocessing biocompatibility. Strong validation programmes start with…

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.

Visual degradation after cleaning, disinfection, or sterilisation is often dismissed as cosmetic, but it can indicate deeper mechanical or chemical damage. Identifying and managing surface changes early is critical to maintaining medical device safety, performance, and compliance.

Chemical agents used during medical device cleaning, disinfection, and sterilisation can degrade metals and polymers, leading to corrosion, embrittlement, discoloration, and additive leaching. These changes can compromise performance, safety, and regulatory compliance. Understanding material compatibility, controlling processing parameters, and validating…

BS EN 17272 testing provides a framework for evaluating hydrogen peroxide disinfection systems, but the evidence and claims it supports depend on factors such as chamber volume, cycle parameters, formulation and organism selection.

Test Labs developed a bespoke, EN/ISO-informed efficacy testing strategy for KISANALITIKA’s TIXAR® after conventional testing methods could not adequately address the product’s unique characteristics.

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

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.