Test Labs Newsletter November 2024

Test Labs MEDICA 2024 Story

Medica 2024 was set to be our biggest event of the year and our second time exhibiting at what’s arguably the largest healthcare conference in the world – or at least in Europe! Preparations began in the summer with the creation of our second edition of Outlook, our annual journal, which we officially launched at the event. Representing Test Labs this year were Tautvydas, Enrico, Marianne, Sophie, and Chris, bringing a wealth of expertise in biocompatibility, IFU validations, microbiology, and mechanical engineering to share with our visitors.

Medical Device Biocompatibility Testing

We offer tests which evaluate cytotoxicity and biological risks within the chemical make-up of a medical device:

• ?Biological Evaluation Plan
• ISO 10993-3 Tests for genotoxicity, carcinogenicity and reproductive toxicity
• ISO 10993-4 Selection of tests for interactions with blood
• ISO 10993-5 Test for cytotoxicity – in vitro methods
• ISO 10993-7 Ethylene oxide sterilization residuals
• ISO 10993-10 Tests for skin sensitization
• ISO 10993-11 Tests for systemic toxicity
• ISO 10993-17 Toxicological risk assessment of medical device constituents
• ISO 10993-18 Chemical characterization of medical device materials within a risk? ?management process
• ISO 10993-23 Tests for irritation – in vitro methods
• Biological Evaluation Report

Our biocompatibility testing is a fundamental step in allowing a medical device to be recognised as safe for use. All medical devices which encounter human tissue should be subject to biocompatibility testing, critically cytotoxicity evaluation. We offer tests which aid in addressing the biocompatibility of medical device materials. These tests are performed to ISO 10993-5 to determine cytotoxic potential.

?To determine which test are relevant to your device, we offer a biological evaluation plan (BEP) which will identify the tests needed for your medical device, as well as sourcing available information on your product. After constructing the BEP and performing the required tests and sourcing the biocompatibility information, Test labs offer a biological evaluation Report (BER) with the complete set of justifications and results on your product.

How Design Changes Impact Biocompatibility in Medical Devices

Sophie Bell

?Medical devices must adhere to rigorous safety standards, but even minor design changes (whether to materials, functionality, or manufacturing processes) can significantly affect biocompatibility. Biocompatibility refers to how well a device interacts with biological tissue during its intended use, without causing adverse effects. When a device’s design changes, it’s essential to re-evaluate its biocompatibility to ensure patient safety.

Challenges Faced by Medical Device Testing Laboratories

Enrico Allegra

The medical device industry is complex and diverse, presenting unique challenges not only for manufacturers but also for the testing laboratories that support them. While much discussion focuses on the hurdles manufacturers encounter in bringing their products to market, the role of testing laboratories is equally critical and fraught with its own set of challenges.