Declaration Of Conformity; Scican Gmbh; Wangener Strasse; 88299 Leutkirch - SciCan STATIM 2000S Manual Del Operador

DECLARATION OF CONFORMITY

Certificate # Rev
99-1010 17
99-1011 17
99-1012 17
Classification:
Manufacturer:
Manufacturer Address:
European Representative:
We herewith declare that the above mentioned products meet the provisions of the following EC Council
Directive and Standards and that SciCan Ltd. has exclusive responsibility for the content of this Declaration of
Conformity. All supporting documentation is retained at the manufacturer's premises.
DIRECTIVE
General Applicable Directive:
Medical Device Directive: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [(MDD
93/42/EEC, Annex II, excluding (4)].
Standards:
Harmonized Standards (published in the Official Journal of the European Communities) applicable to this
product are:
ISO 13485:2003, EN 61010-1:2010, EN 61010-2-040:2015, EN 60601-1-2:2007, EN ISO 14971:2012,
EN 62304:2006, EN 13060:2014.
Additional Product Specific Standards applicable to this product are:
EN 61326-1:2013
Notified Body:
Certificate:
Date CE Mark was affixed:
Product
STATIM 2000S Cassette Autoclave 01-152302, 01-152304, 01-152310,
STATIM 5000S Cassette Autoclave 01-222303, 01-222304, 01-222309,
STATIM 5000S Cassette Autoclave
with Extended Cassette
Class IIa (MDD Annex IX, Rule 15)
SciCan Ltd.
1440 Don Mills Road
Toronto, Ontario
M3B 3P9
Canada

SciCan GmbH

Wangener Straße 78

88299 Leutkirch

Germany
TÜV SÜD Product Service GmbH
Ridlerstraß 65,
D-80339 München, Deutschland
Identification No. 0123
G1 14 02 12160 043
March 24, 1998
Models
01-152320
01-222310, 01-222371, 01-222318
01-232304, 01-01-232310, 01-232318
Telephone (416) 445-1600
Fax (416) 445-2727
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