Considerations for Navigating ISO 22442-3:2007 Viral Inactivation Studies

What is ISO 22442?

EN ISO 22442 is the standard for medical devices that use tissues from preclinical models and their derivatives. Manufacturers must show that they can effectively inactivate and remove viruses from raw materials and finished products. The types and amounts of non-human materials in medical devices differ, including bovine/porcine heart valves and hemostatic sponges, among others.

What is ISO 22442-3:2007?

ISO 22442-3:2007 is a specific part of the ISO 22442 series that focuses on the requirements for the characterization and qualification of non-human tissues and their derivatives used in the production of medical devices. It provides detailed guidelines for assessing the biological safety of these materials, including considerations for sourcing, processing and risk evaluation.

What are viral inactivation studies?

Viral inactivation studies are scientific investigations focused on evaluating methods and techniques to eliminate or deactivate viruses that can present in medical devices. Medical devices that sometimes utilize non-human tissues include catheters, cardiovascular heart valves and vascular grafts, orthopedic bone void fillers and viscosupplements as well as wound care dressings and hemostats.

In order for the EN ISO 22442-3 study process to be as successful as possible, a few important decisions need to be made, including:

• Virus selection — titre, handleability and relevancy to the non-human tissue being investigated must be taken into account
• Appropriate study design — the right expert CRO can make sure you’re meeting the requirements of different regulatory bodies

What else will be covered in the EN ISO 22442 webinar?

Our speakers will explain the use of non-human tissue and derivatives in developing medical devices and how they’re able to enhance performance, stabilize formulations, and improve properties.

They’ll also walk through:

• When and what to think about when pursuing a viral inactivation study
• The ISO 22442-3 study process steps — and the decisions you’ll have to make in the process
• Considerations for molecular screening and batch release
• Common regulatory hurdles and what you can do about them
• NAMSA case studies addressing these questions and concerns