Biocompatibility Evaluation of Breathing Medical Devices: Understanding ISO 18652

Traditionally, toxicologists and biocompatibility experts considered the materials in breathing gas pathways as external communicating devices and evaluated these materials according to the ISO 10993 series of international standards. 1 In the past, testing laboratories would refer to the ISO 109931 matrix of biocompatibility endpoints and simply check off the tests recommended for external communicating devices. Unfortunately, this approach leads to testing that provides questionable benefit and potential hazards being missed. In order to bridge these gaps in ISO 10993, ISO Technical Committee 121 released a new set of standards specifically geared toward the biocompatibility evaluation of breathing gas pathways in healthcare applications. 2 In March 2017, the committee published ISO 18562, a four-part standard aimed at providing the general framework required to adequately determine the acceptability of medical devices that contain breathing gas pathways. 2 This article takes a dive into the testing requirements of ISO 18562 and discusses the details necessary for medtech companies to satisfy this new standard.