Gambro AK 96, Operator'S Manual, Page: 28 / 509

Certification marks
CE-marking
The CE-conformity mark indicates that the AK 96 dialysis machine
conforms to the requirements in the EC Council Directive 93/42/EEC
of 14 June, 1993 concerning medical devices. It also indicates that
the noti fi ed body British Standards Institution (BSI, No. 0086) has
approved the Quality Management System. The CE conformity mark
is only valid for the AK 96 dialysis machine. Disposables and any
accessories speci fi ed for use with the AK 96 dialysis machine are
marked with CE conformity marks in their own right.
CSA-marking
The CSA mark indicates that the AK 96 dialysis machine conforms to
the requirements related to safety of medical devices for Canada and
that the AK 96 dialysis machine has been evaluated to the applicable
CSA standards for use in Canada.
CCC-marking
The CCC mark indicates that the AK 96 dialysis machine conforms to
the safety requirements for China Compulsory Certi fi cation (CCC) as
described by the competent authority Certi fi cation and Accreditation
Administration of People’s Republic of China (CNCA). The “S”
adjacent to the CCC mark indicates that safety requirements are met.
1:22 AK 96 ® Operator's Manual - Before you get started
HCEN12239 Revision 12.2010
Program version 3.xx