DANSK DSF/ISO/DIS 23217 PDF

This document provides guidance on the development of medication delivery systems, which are intended for self-administration of medicinal products to the specific demographic group of paediatric patients who are performing some or all use steps required for its intended use. It also provides requirements that shall be met if the product is declared, labelled and/or claimed for this purpose. Use steps include any handling action performed after receipt of the product to the patient; these may include but are not limited to: – Transport – carrying the product while travelling (e.g. by walking, train, airplane, automobile, bus); – Storage – storage by the patient in their home, school, office or in temporary storage cases before or between uses; – Preparation – steps necessary to place the product in a state where it is ready to be administered; – Operation – steps necessary to initiate, adjust, pause, stop, or otherwise manage the delivery of medication using the product; – Maintenance – steps necessary to keep the product in good working order; – Disposal – steps to ensure safe disposal of the product after use (e.g. placement of the product in a suitable receptacle. Only devices covered by the following documents and intended for use by paediatric patients are in the scope of this document: – ISO 11608 (all parts), Needle-based injection systems for medical use – Requirements and test methods – ISO 21649, Needle-free injectors for medical use – Requirements and test methods – ISO 7886 (all parts), Sterile hypodermic syringes for single use – ISO 8537, Sterile single-use syringes, with or without needle, for insulin – ISO 7864, Sterile hypodermic needles for single use. Although specifically intended for medication delivery systems as noted above, this document could be useful in the development of other systems if they are intended for use by the paediatric population. Devices not in the scope of this document include catheters, for example those in the scope of ISO 10555 series and infusion pump systems, e.g. IEC 60601-2-24 and aerosol delivery devices (ISO 20072).