喷雾给药装置的设计验证.试验方法和要求

[中文适用范围]： 本国际标准旨在用于设备设计验证，而非药物产品质量评估。本国际标准的目的是通过实验室（体外）测试验证，ADDD 设计通过满足设备功能概况（DFP）和系统验证测试，始终符合制造商的设计规格，这两者均基于风险评估确定，并按照使用说明进行评估。本国际标准排除了 ISO 27427 涵盖的连续或半连续气溶胶化设备、不释放活性药物成分（API）的气溶胶化设备、通用气溶胶化设备（用于呼吸机）和雾化器。本国际标准不适用于 ADDD 的单个部件或组件的制造商（例如：（喷雾）泵、阀门、容器等）。注：有时设备可能同时属于本国际标准和 ISO 27427 的范围。委员会设想，产品的预期用途和设备的风险评估将决定制造商选择哪个国际标准进行 ADDD 设计验证。本国际标准概述了 ADDD 设计验证应与基于风险的 ADDD 设备功能概况（与药物、安慰剂或代表性药物结合）一起进行的流程。ISO 27427 概述了对用于非特定类别活性药物成分的雾化系统的气动气溶胶性能进行表征的流程。 [外文原描述]： 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.