ISO 20072:2009适用于用于将计量或预计量的雾化药物输送到或通过人体呼吸道（包括鼻、口腔、气管、支气管和肺泡部位）输送的手持式单次和多次使用气雾剂药物输送装置（ADDD）的设计、标签、使用说明和测试要求。本国际标准适用于个人使用的可再填充和一次性器械。 ISO 20072:2009旨在用于器械设计验证，而非制剂质量评估。本国际标准的目的是通过实验室（体外）试验验证ADDD设计始终符合制造商的设计规范，方法是满足器械功能特性和系统验证试验，两者均由风险评估确定，并根据使用说明进行评估。

ISO 20072:2009 applies to the design, labelling, instructions for use and testing requirements for hand-held single- and multi-use aerosol drug delivery devices (ADDDs) intended to deliver a metered or pre-metered aerosolized medication to or by means of the human respiratory tract (including nasal, oral, tracheal, bronchial and alveolar sites). This International Standard applies to both refillable and disposable devices intended for personal use. ISO 20072:2009 is intended for device design verification and not for drug product quality assessment. The objective of this International Standard is to verify, by laboratory (in-vitro) testing, that the ADDD design consistently meets the manufacturer's design specification by satisfying a device functionality profile and system verification test both of which are determined from a risk assessment and evaluated in accordance with the instructions for use.