9.5.7 Additional regulations and standards
I
ntroduction
This section describes additional information that applies to ÄKTA ready XL.
Biological and chemical
compatibility
The system has no wetted parts. All wetted parts are part of the separate disposable
flow kit.
Additional design considerations
For additional design considerations, such as ASME-BPE, GMP and cGMPs informa-
tion refer to the product-specific specification information provided in the documen-
tation package delivered with the system.
9 Reference information
9
.5 Regulatory information
9.5.7 Additional regulations and standards
166
ÄKTA ready XL Operating Instructions 29281616 AE
*** TeDIS Valid on Date Printed Printed on: 15-09-2023 11:27:35 ***