Labeling Symbols - FujiFilm SonoSite Edge II Manual De Instrucciones

Labeling symbols

Table 1-6: Standards labeling symbols
Symbol Title
Manufacturer
Non-ionizing
electromagnetic
radiation
European
community
authorized
representative
Serial number
Catalog number
Labeling symbols
Standards development
organization
ISO 15223-1:2016
Medical devices – symbols
to be used with medical
device labels, labelling, and
information to be supplied –
Part 1: General requirements
IEC 60601-1-2:2007
Medical Electrical
Equipment Part 1-2: General
requirements for basic
safety and essential
performance – collateral
standard: electromagnetic
compatibility
ISO 15223-1
Medical devices - symbols
to be used with medical
device labels, labelling and
information to be supplied.
ISO 15223-1:2016
Medical devices – symbols
to be used with medical
device labels, labelling, and
information to be supplied –
Part 1: General requirements
ISO 15223-1:2016
Medical devices – symbols
to be used with medical
device labels, labelling, and
information to be supplied –
Part 1: General requirements
Reference
Description
number
5.1.1 Indicates the medical device
manufacturer, as EU
directives 90/385/EEC,
93/42/EEC and 98/79/EC
5.1.1 Indicates generally elevated,
potentially hazardous levels
of non-ionizing radiation, or
to indicate equipment or
systems e.g., in the medical
electrical area that include
RF transmitters or that
intentionally apply RF
electromagnetic energy for
diagnosis or treatment
5.1.2 Indicates the Authorized
representative in the
European Community
5.1.7 Indicates the manufacturer's
serial number so that a
specific medical device can
be identified
5.1.6 Indicates the manufacturer's
catalog number so that the
medical device can be
identified
23