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.

A practical guide to building Biological Evaluation Reports (BERs) that meet today's Notified Body expectations through chemistry-led evidence, robust toxicological assessment and integrated risk management.

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,…

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.

ISO 10993-12 provides guidance on sample selection, extraction conditions and reference materials to ensure biocompatibility testing generates relevant and scientifically defensible results.

Worst-case justification allows medical device manufacturers to validate reprocessing using the most challenging device in a product family, saving time, cost, and resources. Test Labs applies a structured, standards-based approach aligned with ISO and AAMI guidance to identify, assess, and…

Low temperature hydrogen peroxide sterilisation (VHP) provides an effective, low-residue alternative for heat and moisture-sensitive medical devices. Guided by ISO 22441:2022, it requires rigorous validation and material compatibility testing to ensure consistent sterility and device integrity. When properly validated, VHP…

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…

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

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…

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,…

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…

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.

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.

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.

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.