6
Doc. No.
：
P30001PE0101-07
CE mark for Europe
Regulation (EU) 2017/746 (IVD Directive)
This instrument has been tested and complies with the
following standards:
IEC61010-1 Amd.1 Ed3: 2016
, “Safety requirements for
electrical equipment for measurement, control and
Laboratory use
‐
Part 1: General r
equirements”
IEC61010-2-101: 2018
, “Safety requirements for electrical
equipment for measurement, control, and laboratory use
‐
Part 2
‐
101: Particular requirements for in vitro diagnostic
(IVD) medical equipment
”
EN61326-1:
2013, “Electrical equipment for measurement,
control and laboratory use EMC requirements
– Part1:
General requirements”
EN 61326-2-6:
2013, “Electrical equipment for measurement,
control and laboratory use EMC requirements
– Part2-6:
Particular requirements in vitro diagnostic (IVD) medical
equipment.”
About the symbol of label
The symbols on the labels for devices other than those listed above are described below.
Serial number
Indicate the manufacturer’s serial number so that a specific
medical device can be identified.
YYYYMMDD
Country of manufacture
“Japan”
To identify the country of manufacture of products.
The date of manufacture.
Unique device identifier
Indicates a carrier that contains unique device identifier
information.
UL listing mark for Canada and the USA
This instrument has been tested and complies with
standards UL 61010
-
1 Ed.3 (2012) and CSA-C22.2
No.61010-1-
12 Ed3. (2012), “Safety Requirements for
Electrical Equipment for Measurement, Control and
Laboratory Use, Part 1: General Requir
ements.”
This product complies with the WEEE Directive (2002/96/EC)
marking requirement. This marking indicates that you must
not discard this electrical/electronic product in domestic
household waste.
