User Manual Part 1

22
2852 A EN 20070205
DRYSTAR AXYS
Compliance
This paragraph sums up the directives, standards and harmonization initiatives
Drystar AXYS complies with.
Directive
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ
No L 169/1 of 1993-07-12)
Q ANNEX I - ESSENTIAL REQUIREMENTS - GENERAL REQUIREMENTS
The devices are designed and manufactured in such a way that, when used
under the conditions and for the purposes intended and, where applicable, by
virtue of the technical knowledge, experience, education or training of
intended users, they will not compromise the clinical condition or the safety of
patients, or the safety and health of users.
Q ANNEX II - EC DECLARATION OF CONFORMITY
Full quality assurance system ISO 13485
Q ANNEX X - CLINICAL EVALUATION
The clinical evaluation follows a defined and methodologically sound proce-
dure.
Quality Control
Q The Quality Control test procedure for general radiography applications (refer
to “Quality Control for general radiography applications (DT 2 B & DT 2 C)” on
page 87complies with the grayscale reproduction constancy test, according to
the international standard IEC 1223-2-4.
Q The Quality Control test procedure for the optional mammography application
(refer to “Quality control for mammography application (DT 2 Mammo)
(optional)” on page 104 ) complies with the NEMA Standards Publication XR
23-2006