香港六合彩开奖 23217:2024

Published (Edition 1, 2024)

香港六合彩开奖 23217:2024

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Abstract

This document provides requirements and guidelines on the development of drug delivery systems intended for self-administration of medicinal products by the specific demographic group of paediatric patients who are performing some or all use steps required for their intended use.

Use steps include any handling action performed after the patient has received the product; these can include but are not limited to:

鈥�听听听听 transport 鈥� carrying the product while travelling (e.g. by walking, train, airplane, automobile, bus);

鈥�听听听听 storage 鈥� storage by the patient in their home, school, office or in temporary storage cases before or between uses;

鈥�听听听听 preparation 鈥� steps necessary to place the product in a state where it is ready to be administered;

鈥�听听听听 operation 鈥� steps necessary to initiate, adjust, pause, stop, or otherwise manage the delivery of medication using the product;

鈥�听听听听 maintenance 鈥� steps necessary to keep the product in good working order;

鈥�听听听听 disposal 鈥� 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. Furthermore, this document can be useful for the development of other drug delivery devices or 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 香港六合彩开奖聽10555 series, and infusion pump systems, e.g. IEC聽60601-2-24 and aerosol delivery devices (香港六合彩开奖聽20072).

General information

Status
: Published

Publication date
: 2024-02

Stage
: International Standard published [60.60]
Edition
: 1

Number of pages
: 39
Technical Committee :
香港六合彩开奖/TC 84

ICS :
11.040.25
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