Harmonization - AGFA DX-G User Manual

Harmonization

This document has been prepared to comply with the Study Group 1 guidance
document of the Global Harmonization Task Force (GHTF) (www.ghtf.org).
To assist development of a consistent, harmonized definition for a medical
device that could be used within a global regulatory model would offer
significant benefits to the manufacturer, user, patient or consumer, and to
Regulatory Authorities and support global convergence of regulatory systems.
The IECEE CB Scheme is the world's first truly international system for
acceptance of test reports dealing with the safety of electrical and electronic
products. It is a multilateral agreement among participating countries and
certification organizations. Agfa has produced a CB test report and claims
national certification in all other member countries of the CB Scheme.
2321 E EN 20130722
DX-G/DX-M
85