User Manual Part 1

2852 A EN 20070205

DRYSTAR AXYS

Additional standards for documentation

IEC 62079 Ed. 1: Preparation of instructions - Structuring, content and presen-

tation

Harmonization

Q Global Harmonization Task Force (GHTF) www.ghtf.org

This document been has prepared to comply with Study Group 1 guidance doc-

ument of the Global Harmonization Task Force (GHTF). 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 manu-

facturer, user, patient or consumer, and to Regulatory Authorities and support

global convergence of regulatory systems.

Q IECEE CB SCHEME www.iecee.org

The IECEE CB Scheme is the world's first truly international system for accep-

tance of test reports dealing with the safety of electrical and electronic prod-

ucts. 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.