Microm HM 355 S Instruction Manual page 8

Name and address of
the manufacturer:
Product designation:
Type reference:
Notification to Competent Authorities:
These medical devices 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)
MICROM International GmbH
Robert-Bosch-Str. 49
D- 69190 Walldorf
EC Certificate of Conformity
MICROM International GmbH
Robert-Bosch-Straße 49
D-69190 Walldorf
Rotary Microtome
HM 355 S -2
of 27 October 1998
on in vitro diagnostic medical devices
Rotary Microtome HM 355 S
387841 - English