General - AGFA Drystar AXYS User Manual

General

• The product has been designed in accordance with the MEDDEV
Guidelines relating to the application of Medical Devices and has been
tested as part of the conformity assessment procedures required by 93/42/
EEC Medical Device Directive (European Council Directive 93/42/EEC on
Medical Devices).
• ISO 14971:2000
• IEC 60601-1-2
• The Quality Control test procedure for general radiography applications
complies with the grayscale reproduction constancy test, according to the
international standard IEC 1223-2-4.
• The Quality Control test procedure for the optional mammography
application complies with the NEMA Standards Publication XR 23-2006.
Related Links
Quality Control for general radiography applications
Quality Control for mammography application
Drystar AXYS | Introduction | 39
on page 94
on page 107
2852D EN 20161128 1416