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BS ISO 20069:2019

Guidance for assessment and evaluation of changes to drug delivery systems

standard by British Standard / International Organization for Standardization , 08/07/2019

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Full Description

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


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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:
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