AGFA DRYSTAR 5302 Technical Documentation Manual page 19

DD+DIS238.06E
Applied Standards for HealthCare Imaging Products
• IEC 60601-1, Ed. 3: Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
• ISO 14971:2000, Medical devices – Application of risk management to medical devices
• IEC 60601-1-2, It specifies the MANUFACTURER of the ME EQUIPMENT or ME
SYSTEM provides information to the RESPONSIBLE ORGANIZATION that is essential
in determining the suitability of the ME EQUIPMENT or ME SYSTEM for the
electromagnetic environment of use, and in managing the electromagnetic environment
of use to permit the ME EQUIPMENT or ME SYSTEM to maintain BASIC SAFETY and
provide its ESSENTIAL PERFORMANCE without disturbing other equipment.
Additional standards for documentation:
IEC 62079 Ed. 1: Preparation of instructions - Structuring, content and presentation
Harmonization:
Global Harmonization Task Force (GHTF)
This document has been prepared to comply with Study Group 1 guidance document
of the Global Harmonization Task Force (GHTF)
of a consistent, harmonized definition for a medical device that could be used within a
global regulatory model and would offer significant benefits to the manufacturer, user,
patient or consumer, and to Regulatory Authorities and support global convergence of
regulatory systems.
IECEE CB SCHEME
The IECEE CB (Certification Body) 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.
Details see
Edition 1, Revision 3
07-2009
www.iecee.org
The controlled version of this document resides on MedNet. Any printed copy of this document is uncontrolled.
Generic Safety Directions for HealthCare Imaging Products
www.ghtf.org/
www.ghtf.org/
DOCUMENT CONTROL NOTE:
Generic Safety Directions
to assist development
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Agfa Company Confidential
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