Comparison of ISO standards for device performance; 20072 and 27427: a critical appraisal.

Abstract Two separate international standards, ISO 20072:2009 and ISO 27427:2010, have recently been published that relate to the development and performance testing of oral inhaled products (OIPs). The scope of ISO 20072 encompasses all OIP forms except nebulizing systems, whereas ISO 27427 was developed specifically for this class of OIP. Compliance with these standards will likely be necessary for manufacturers seeking approval to market inhaler devices in the European Union (EU). Their adoption in the United States may take a considerable time, but the FDA has expressed support in general terms for the ISO process. Key aspects of both standards that are very different in style and content are identified and discussed from the perspective of a potential user. In the approach adopted by ISO 20072, a formalized risk assessment is undertaken as a key part of design verification, in order to develop the Device Functionality Profile (DFP) of the device. The DFP is subsequently verified by the System Verific...