AGFA CR 30-X User Manual page 118

October 2006
saFeTy
Region Regulation
europe EN 60601-1: 1990 +
A1: 1993 + A2: 1995
EN 60601-1-2: 2001
UL 60601-1
usa
21CFR part 820: good
manufacturing practice for
medical devices
Canada CSA22.2 No.601.1 No.601.1.2
agfa-gevaert has been certified by lloyd's Register Quality assurance limited to the following quality
management system standard: isO 9001:2000. the quality management system is applicable to: for
healthcare applications - marketing, design, development and production of imaging and communication
solutions (film, paper and plates, chemicals, components, equipment and software).
agfa-gevaert has been awarded the approval of Conformity certificate by lloyd's Register Quality
assurance. it certifies that the Quality management system for our X-Ray films conforms to the
requirements of annex V of the eeC directive 93/42. agfa healthCare has been certified by lloyd's Register
Quality assurance limited to the following quality management system standards: isO 9001:2000 and
en isO 13485-2003. the quality management system is applicable to: marketing, design, development
and production of imaging and communication solutions (film, paper and plates, chemicals, components,
equipment and software) for healthcare applications. agfa-gevaert had been awarded the isO 9001
certificate by tÜV zertifizierungsgemeinschaft e.V. this is applicable to agfa's Quality management system
for design, production and servicing of agfa medical equipment. products distributed in north america are
manufactured by/for agfa Corporation, 10 south academy st., greenville, south Carolina 29601. agfa, the
agfa rhombus and musiCa are trademarks of agfa-gevaert n.V., belgium or its affiliates. all other trademarks
are held by their respective owners and are used in an editorial fashion with no intention of infringement.
the data in this publication are for illustration purposes only and do not necessarily represent standards or
specifications which must be met by agfa. all information contained herein is intended for guidance purposes
only, and characteristics of the products described in this publication can be changed at any time without
notice. products may not be available for your local area. please contact your local sales representative for
availability information. agfa diligently strives to provide as accurate information as possible, but shall not
be responsible for any typographical error.
© Copyright 2006 agfa-gevaert n.V. all rights reserved.
X-Ray
Regulation: 1987
DHHS/FDA 21 CFR
part 1002, subchapter B
ngKVu us 00200610
CR 30-X digitizer
Laser
EN 60825 - 1:2001
DHHS/FDA 21
CFR parts 1040, 10
and 1040, 11
Agfa Corporation
healthCare headquarters
10 south academy street,
greenville, sC 29601
Canada
agfa, inc.
77 belfield Road, etobicoke, Ont.,
m9w 1g6
Mexico
agfa de méxico, s.a. de C.V.
benjamin franklin #98, Colonia
escandon, C.p. 11800, méxico, d.f.