The main purpose of ISO 10993-1 is to focus on a risk-based approach for evaluating biocompatibility of medical devices and to ensure patient safety. A second goal of the document is to ensure animal welfare and to minimize the number and exposure of animal tests. The introduction of the requirement for a biological evaluation plan in ISO10993-1 in 2018 and the need to rely on chemical and physical information to evaluate the necessity of in-vivo testing is an important step towards a reduction of the use of lab animals.
With this persisting concern regarding the unnecessary use of lab animals in Europe and the US, legislation and regulations are implementing the reduction of the use of animals for testing medical devices at an increasing rate which forces the industry to look for in vitro alternatives.
In 2021, an in vitro irritation test was accepted by ISO 10993 where Nelson Labs US played a leading role. This leaves one test from the big three (cytotoxicity, sensitization, irritation) as the only test that still requires lab animals.
Currently a huge effort is being undertaken to assess and validate already accepted OECD methods for in vitro sensitization for the testing of medical devices. Nelson Labs has been investigating in vitro sensitization methods for the past several years.
This presentation will focus on the road towards an animal free testing environment to evaluate the biological safety of Medical Devices and present the current status for animal free test methods.