DD+DIS238.06E
Generic Safety Directions
DOCUMENT CONTROL NOTE:
The controlled version of this document is available from the Agfa HealthCare Library. Any printed copy of this document is uncontrolled.
Edition 1, Revision 5
Generic Safety Directions for HealthCare Imaging Products
Page 15 of 30
Applied standards
for Agfa HealthCare Imaging medical electrical equipment:
NOTE:
Equipment delivered by Agfa HealthCare is not necessarily classified as medical
electrical equipment. For details refer to the related user and /or service manual.
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 (
M
edical
E
lectrical) 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 82079 Ed. 1: Preparation of instructions for use - Structuring, content and
presentation
Harmonization:
Global Harmonization Task Force (GHTF)
http://www.imdrf.org
This document has been prepared to comply with Study Group 1 guidance document 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 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:
www.iecee.org
04-2014
Agfa Company Confidential