Additional Standards For Documentation; Harmonization - AGFA Drystar AXYS User Manual

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Additional standards for documentation

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

tation

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.

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.

2852 A EN 20070205

AXYS

RYSTAR

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