Bedfont GastroCH4ECK Gastrolyzer User Manual page 27

Manufacture
Type BF Applied Part
(Whole Device)
Temperature limit
Humidity limitation
Atmospheric pressure
limitation
Authorised
representative in the
European Community
Unique device
identifier
Medical Device
Catalogue number
CE mark
Bedfont® logo
Indicates the medical device
manufacturer (*Note – Date of
manufacture, name and address of
manufacturer can be combined in
one symbol
To identify a type BF applied part
complying with IEC 60601-1
(Degree of protection against
electric shock)
Indicates the temperature limits to
which the medical device can be
safely exposed
Indicates the range of humidity to
which the medical device can be
safely exposed
Indicates the range of atmospheric
pressure to which the medical
device can be safely exposed
Indicates the authorised
representative in the European
Community
Indicates a carrier that contains
unique device identifier
information
Indicates the item is a medical
device
Indicates the manufacturer's
catalogue number so that the
medical device can be identified
Manufacturer's declaration of
compliance to all relevant
European Medical Device
Regulations
Manufacturers logo
ISO 15223 – 1. Clause
5.1.1
ISO 7000 – 3082
IEC 60417-5333
IEC 60601-1, Table
D.1, Symbol 20
ISO 15223 – 1. Clause
5.3.7
ISO 7000 – 0632
ISO 15223 – 1. Clause
5.3.8
ISO 7000 – 2620
ISO 15223 – 1. Clause
5.3.9
ISO 7000 – 2621
ISO 15223 – 1. Clause
5.1.2
ISO 15223 – 1. Clause
5.7.10
ISO 15223 – 1. Clause
5.7.7
ISO 15223 – 1. Clause
5.1.6
ISO 7000-2493
European Directive
93/42/EEC
n/a
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