Abstract
Abstract In case of cardiovascular implants classified as class III medical products there is a specific responsibility for manufacturers as well as regulatory authorities to follow international standards to guarantee for safety and efficacy. Fast developments of science and technology as well as novel clinical findings create permanent needs to match the standardization. Therefore, a set of international standards is analyzed with respect to their use for particular coronary drug-eluting stents and artificial heart valves. It was found that standards (ISO, ASTM) exist for general requirements on passive implants, but also specifically relate to arterial stents, stent grafts, bioresorbable and drug-eluting stents, as well as artificial heart valves. New work items address new methods for characterization of coating integrity, particulate matter and simulated use testing. European Medical Device Regulation (MDR) requires technical expertise and capacity at Notified Bodies supported by independent test laboratories. Generally, the interest in standardization from industry, test laboratories and authorities is high, but more input from medical experts would further improve the value of standardization and its relevance for safe and even more effective implants.
Highlights
Technical standards represent a consensus of the current state of technology
In case of cardiovascular implants which are classified as class III medical products there is a specific responsibility for manufacturers as well as regulatory authorities to follow these recommendations
There is a permanent need to adapt these standards to the fast progress of science and technology, which results in a complex and time-consuming process of standard development
Summary
Technical standards represent a consensus of the current state of technology. They support product development and guarantee their safe and efficient use. In case of cardiovascular implants which are classified as class III medical products there is a specific responsibility for manufacturers as well as regulatory authorities to follow these recommendations. A couple of new requirements came up. Referencing standards can help to reduce the efforts to the technically relevant minimum without losing information about product safety and efficacy. This study is considering normative and informative guidance from standardization under the new requirements of the MDR. The need for new test methods is derived by presenting exemplary technical solutions
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
