scope:

This International Standard applies to the performance and testing requirements for hand-held single- and multi-use aerosol drug delivery devices (ADDD) intended to deliver a metered or pre-metered aerosolized medications to or by means of the human respiratory tract (includes nasal, oral, tracheal, bronchial and alveolar sites). This includes hand-held devices intended for personal use both refillable and disposable. The objective of this standard is to verify, by laboratory (in-vitro) testing, that the ADDD design consistently meets the manufacturer's design specification and performance profile when used in accordance with the instructions for use as determined by a risk assessment. ADDD's described herein are typically referred to as "combination products" in that they are designed to be used with a specific active pharmaceutical ingredient. The standard excludes continuous or semi-continuous aerosolization devices covered in ISO 27427 1 ) 'Respiratory therapy and other equipment - Nebulizing systems and components', aerosolization devices which do not emit API, general purpose aerosolization devices (for use with ventilators), and atomizers. NOTE There may be times, however, when a device falls under the scope of this standard and ISO 27427. The committee envisions that the intended use of the product and the risk assessment of the device will drive which standard the manufacturer chooses for design verification of the ADDD. ISO 20072 outlines the process by which ADDD design verification is to be made in conjunction with a risk based performance profile of the ADDD with either the intended active pharmaceutical ingredient or a representative material. ISO 27427 outlines the process undertaken by which the characterization of the aerodynamic aerosol performance of a liquid delivery device designed for use with a non-specific class of active pharmaceutical ingredient(s)is made.