Full Description

This document provides guidance for assessment and evaluation of planned changes to drug deliverysystems that are integral with, packaged with, or cross-labelled for use with a specified medicinalproduct. This document is applicable to the drug delivery system's lifecycle from registration clinicalstudies to end-of-life. This document is applicable to the assessment of changes within the followingdrug delivery systems:

needle-based injection systems for medical use;
aerosol drug delivery devices;
needle-free injectors for medical use.

Cross References:
IEC 62304
ISO 62366-1
ISO 11608 (all parts)
ISO 12417-1
ICH Q8
ISO/TR 19244
ICH Q12
IEC 60601-1
ISO 14971
ISO 13485
ISO 20072
ISO 10993 (all parts)
ICH Q10
ICH Q9
ISO 21649


All current amendments available at time of purchase are included with the purchase of this document.

Product Details

Published: 08/07/2019 ISBN(s): 9780580961946 Number of Pages: 44 File Size: 1 file , 2.4 MB Same As: ISO 20069:2019 Product Code(s): 30350510, 30350510, 30350510 Note: This product is unavailable in United Kingdom