BS EN ISO 20072:2013 pdf free download.Aerosol drug delivery device design verification Requirements and test methods (ISO 20072:2009). 5 Requirements 5.1 General Unless justified by the risk assessment, the following general requirements apply. a) The ADDD shall be designed so thatten operated in accordance with the instwctions for use, it provides the emitted mass or dose as specified and verified by the ADDD manufacturer (see 5.4). b) The ADDD shall be designed so that the operator is aware that the ADDD has been actuated. c) The ADDD shall be designed to minimize the risk of inadvertent actuation, d) The performance of the combination of the ADDD and any accessory specified by the ADDD manufacturer shall comply with the device functionality profile and system verification test applicable to that combination. The manufacturer shall identify as part of the ADDD or ADDD system the specific accessories that are suitable for use. e) The ADDD shall be designed so that the operator can determine when the medication intended to be delivered is near completion and is near or has reached exhaustion. 1) A prefilled ADDD with an actuation counter or content indicator shall not reset once the end of life is reached. A…