Kirsch BL Series - Declaration of Conformity

13.1 Declaration of conformity
Device category
Device category
Type
Serial numbers
from serial number onwards
KIRSCH
Refrigerator
BL-100
100 32 25000
KIRSCH
Refrigerator
BL-100
100 03 25000
KIRSCH
Refrigerator
BL-176
170 30 25000
KIRSCH
Refrigerator
BL-176
170 04 25000
KIRSCH
Refrigerator
BL-300
280 31 25000
KIRSCH
Refrigerator
BL-300
280 09 25000
KIRSCH
Refrigerator
BL-520
500 32 25000
KIRSCH
Refrigerator
BL-520
500 06 25000
KIRSCH
Refrigerator
BL-720
700 31 25000
KIRSCH
Refrigerator
BL-720
700 03 25000
0483
Appendix
Declaration of conformity
18.12.2018 Refrigerator/freezer BL series 73
Directives
 DIN EN ISO 9001:2015
 DIN EN ISO 13485:2016
 DIN EN ISO 14971:2012
 DIN 58371:2010-09
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
EC Declaration of Conformity
We,
Philipp Kirsch GmbH
Im Lossenfeld 14
77731 Willstätt-Sand
Germany
hereby declare on our sole authority that the devices of type BL described below, to which the declaration refers,
comply with the applicable requirements 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.