Ec Certificate Of Conformity - Microm HM 550 Serie Manual De Instrucciones

Name and address of
the manufacturer:
Product designation:
Type reference:
Notification to Competent Authorities:
These medical device have been registered with the German authority as "Microtomes" under
the EDMA-classification code: 23-06-02
The designated product complies with the laid down regulation:
DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
The designated product complies with the EC regulations by strictly observing the following
norms:
DIN EN ISO 14971:2001-03
Medical devices - Application of risk management to medical devices (ISO 14971:2000).
DIN EN 61010-1:2002-08
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1:
General requirements (IEC 61010-1:2001).
DIN EN 61010-2-101:2003-09
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-
101: Particular requirements for In-Vitro-Diagnostic-(IVD)-Medical instruments.
DIN EN 61010-2-081:2002-12
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-081:
Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other
purposes (IEC 61010-2-081:2001).
DIN EN 61326:2002-03
Electrical equipment for measurement, control and laboratory use - EMC requirements (IEC 61326-
1:1997 + A1:1998 + A2:2000); German version EN 61326:1997 + A1:1998 + A2:2001
DIN EN ISO 9001:2000
Quality management systems - Requirements (ISO 9001:2000)
Hans Heid Hans Heid Hans Heid Hans Heid
Managing Director Managing Director Managing Director Managing Director
MICROM International GmbH
Robert-Bosch-Str.49
D- 69190 Walldorf

EC Certificate of Conformity

MICROM International GmbH
Robert-Bosch-Straße 49
D-69190 Walldorf
Microtome Cryostat
HM 550 [U-W-X-Y-Z]
of 27 October 1998
on in vitro diagnostic medical devices
HM 550 Serie
Walldorf, 10 February 2004 Walldorf, 10 February 2004 Walldorf, 10 February 2004 Walldorf, 10 February 2004
387 750 - Español