ISO INTERNATIONAL STANDARD 20072 First edition 2009-08-01 Aerosol drug delivery device design verification Requirements and test methods Verification de la conception d'un dispositif d'administration de médicament sous forme d'aérosol - Exigences et méthodes d'essai Reference number ISO 20072:2009(E) @ISO 2009 py IHS under ted without license from IHS Not for Resale ISO 20072:2009(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by IsO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below COPYRIGHTPROTECTEDDOCUMENT @ ISO2009 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, IsO's member body in the country of the requester. ISO copyright office Case postale 56. CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ ISO 2009 - All rights reserved edwithoutlicense from IHS Not for Resale ISO 20072:2009(E) Contents Page Foreword. Introduction 1 Scope 2 Normative references. 3 Terms and definitions 4 Symbolsandabbreviatedterms 6 5 Requirements 5.1 General... 5.2 Risk assessment requirements 5.3 Devicefunctionalityprofile.... .8 5.4 Systemverificationtest 5.5 Uncertainty of measurements and conformance with specification. 5.6 Test requirements. 6 Test methods 6.1 General...... 6.2 Test procedures 12 6.3 Test conditions .16 6.4 Test evaluations 17 7 Test report 8 Information supplied by the manufacturer .19 8.1 General. .19 8.2 Marking. 19 8.3 Instructionsforuse .20 Annex A (informative) Rationale for requirements . .22 Annex B (informative) Further guidance and clarification of the device functionality profile .... ...24 AnnexC(informative)Rationalefortestmethods. .26 Annex D (informative) Two-sided tolerance limit factors (k).. Annex E (informative) Alternative acceptance criteria for the device functionality profile evaluation .... Bibliography.... Copyright International Organizaion for Standardizalon'ghts reserved ii nse from IHS Not for Resale