Kirsch BL Series - Page 74

We also declare that the devices of type FROSTER-BL described below, to which the declaration refers, comply
with the conformity assessment procedure according of Directive 93/42 EEC for medical devices.
The devices belong to Class IIa according to Appendix IX of the Directive above. The named authority, mdc medical
device certification GmbH, Kriegerstraße 6, 70191 Stuttgart, s included in the conformity procedure according to
Appendix II of Directive 93/42/EEC.
Registration-Nr.: D1423300009
We furthermore declare that the devices described below comply with the applicable requirements of the RoHS
Directive 2011/65/EC and the protection requirements of the standards below at the time that the device was placed
on the market.
Willstätt, 13.07.2018
Dr. Jochen Kopitzke
Managing Director
Device category
Device category
Type
Serial numbers
from serial number onwards
KIRSCH
Freezer
FROSTER-BL-178
170 05 25000
KIRSCH
Freezer
FROSTER-BL-180
180 01 25000
KIRSCH
Freezer
FROSTER-BL-330
320 02 25000
KIRSCH
Freezer
FROSTER-BL-530
500 10 25000
KIRSCH
Freezer
FROSTER-BL-650
650 01 25000
KIRSCH
Freezer
FROSTER-BL-730
700 03 25000
0483
Appendix
Declaration of conformity
18.12.2018Refrigerator/freezer BL series74
Standards
 DIN EN ISO 9001:2015
 DIN EN ISO 13485:2016
 DIN EN ISO 14971:2012
 DIN 58375:2004-11
Harmonised standards
 EN 55014-1:2006/A2:2011
 EN 55014-2:1997/A2:2008
 EN 60335-1:2012
 EN 60335-2-89:2010
 EN 60601-1-2:2015 chapter 7, 8
 IEC 60601-1-2:2014 chapter 7, 8
 EN/IEC 64000-3-2:2014
 EN/IEC 61000-3-3:2013