Microm STP120 Doku Takip Cihazı (Tıbbi Amaçlı)
STP 120
EC Uyum Belgesi
Name and address of MICROM International GmbH
the manufacturer: Robert-Bosch-Straße 49
D-69190 Walldorf
Product designation: Tissue Processor
Type reference: STP 120
Notification to Competent Authorities:
These medical device have been registered with the German authority as “General
Histology Instruments” under the EDMA-classification code: 23-06-01
The designated product complies with the laid down regulation:
DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 27 October 1998
on in vitro diagnostic medical devices
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 61010-2-010:1995-03
Safety requirements for electrical equipment for measurement, control and laboratory use
-
Part 2-010: Particular requirements for laboratory equipment for the heating of materials
(IEC 61010-2-010:1992, modified); German version EN 61010-2-010:1994
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