7
Declaration of Conformity
Directive 93/42/EEC, medical equipment and automatic weighing instruments Directive 90/384/EEC
Department of Precision Mechanics
A.J. Lewandowscy
ul. W
ę
glarska 50, 04-689 Warszawa
www.mensor.pl
I conclude that medical scales of our production, the following below mentioned
types meet European standards in the ISO / IEC 45501, and Council of Europe:
93/42/EEC for the first class of medical devices with measuring function and Directive
90/384/EEC for automatic weighing instruments.
Type of scale:
description designation
PL
designation
DE
serial
number
amount
scales for baby weighing
WE15P2
PCE-PS-15 MBS
scales for baby weighing
WE20P2
PCE-PS-20 MBS
personal medical scale for man
WE150P1
PCE-PS-150 MPC
personal medical scale for man
WE200P1
PCE-PS-200 MPC
medical chair scale
WE150P3 K
PCE-PS-150 MCS
personal scale with mechanical measuring syst. WE150P3 M
PCE-PS-150 MM
personal scale with mechanical measuring syst
WE200P3 M
PCE-PS-200 MM
personal scale with electronic measuring system WE150P3 W
PCE-PS-150 MA
personal scale with electronic measuring system WE200P3 W
PCE-PS-200 MA
personal scale with the display on the pipe arm
WE150P3
PCE-PS-150 MPS
personal scale with the display on the pipe arm
WE200P3
PCE-PS-200 MPS
medical bad scale
WE300P1 L
PCE-PS-300MBW
bariatic scale
WE200P4
PCE-PS-200 MSH
special scale for weighing patients in wheelchair WM150P1 50x90Z PCE-PS-150 MXL
We hereby declare that the above medical scales meet the requirements of Annex V and Annex I of Council
of the European Economic Community No. 93/42/EEC of 24 June 1993, implemented into Polish law of
Medical Devices Act of 20 April 2004 and the Decree of the Minister of Health of 3 November 2004 on the
basic requirements for medical devices for various purposes and the following harmonized standards: PN EN
45501, EN 61010-1, European Council Directive 73/23/EEC (Low Voltage Directive), PN 1041-2009, PN EN
ISO 14971 - 2009, ISO 13485, BS 60950-2000, PN EN 60065:2001, EN 55022:2000, PN EN 55013 + A: 1997
Conformity assessment according to Annex V of Directive 93/42/EEC was performed with the involvement of a
Notified Body No. 1434, and in / g directive 90/384/EEC Notified Body No. 1440th
Obtained Certificate of EC Type Approval No. PL 06 003 dated 21-04-2006 the Central Office of Measures.
Obtained Certificate of Conformity No. MD - 220/1/2009 date of application of the CE mark – 2009.
M a n a g e r
Warsaw 2009
dr in
ż
. Janusz Lewandowski
06
1440 1434
