scope:

This document provides guidelines on the development of drug 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 on when 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 can 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.

This document is applicable to injectable drug delivery systems for administration of medicinal products covered under the scope of ISO/TC 84. See Figure 1.

However, this document can also be useful for development of other drug delivery devices or systems.

This document can 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).