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16 | Auto QC² | Introduction
Compliance
Auto QC² 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 MDD
(European Council Directive 93/42/EEC on Medical Devices).
This Agfa product has been designed in accordance with the IEC 60601-1, Ed.
3: Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance.
Auto QC² is compliant with the IEC 61267 standard for Medical Diagnostic X-
Ray Equipment and Radiation conditions for use in the determination of
characteristics.
The concepts used for quality control with Auto QC² are defined using the
AAPM Report of Task Group 10 (Acceptance Testing and Quality Control for
photostimulable storage phosphor imaging systems) as a guideline.
2370C EN 20180330 1524
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