Publications : 2019

Mihalchik-Burhans AL, Rogers EN. 2019. Considerations for leachables and extractables testing. In: Gad S (ed), Integrated Safety and Risk Assessment for Medical Devices and Combination Products, pp. 239–263. Springer.


Excerpt from Abstract: This chapter provides a summary [of] the regulation, experimental design, and analytical techniques commonly utilized in extractables and leachables (E&L) testing for medical devices. Extractables are indicated as chemical compounds generated under aggressive, exaggerated experimental conditions, while leachables are chemical compounds expected to be present in a medical device under clinical use conditions…