This document provides guidance for assessment and evaluation of planned changes to drug delivery
systems that are integral with, packaged with, or cross-labelled for use with a specified medicinal
product. This document is applicable to the drug delivery system's lifecycle from registration clinical
studies to end-of-life. This document is applicable to the assessment of changes within the following
drug 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. | File Size : | 1
file
, 2.4 MB |
| ISBN(s) : | 9780580961946 |
| Note : | This product is unavailable in Russia, Ukraine, Belarus |
| Number of Pages : | 44 |
| Product Code(s) : | 30350510, 30350510, 30350510 |
| Published : | 08/07/2019 |
| Same As : | BS ISO 20069:2019 |
