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…

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 10993-12:2021 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,…

This article explores cytotoxicity testing, a critical step in assessing the biocompatibility of medical devices. It explains how cytotoxicity studies are conducted using in vitro methods to evaluate whether materials used in a device cause cell damage or death.

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.

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…

Residual hydrogen peroxide can pose hidden risks in sterilised medical devices, impacting both patient safety and regulatory compliance. ISO 22441 and ISO 10993 standards provide frameworks for assessing toxicological risk, guiding manufacturers through chemical characterisation, extraction studies and Margin of…

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.

Pre-compliance testing is a valuable tool for product development, as it allows you to proactively identify potential failures

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.

Post-cleaning, any residual ATP is collected from the sample and measured using the ATP bioluminescence monitor

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.

This course is specifically designed for medical device manufacturers seeking to enhance their understanding of laboratory processes and regulatory requirements for medical devices.

Pre-compliance testing is a valuable tool for product development, as it allows you to proactively identify potential failures

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.