Table 3: Standards labeling symbols
Symbol
Title
Fragile handle with
care
Keep dry
Medical Device
MD
Temperature limit
Atmospheric
pressure limitations
12
Standards development
organization (SDO)
ISO 15223-1:2016
Medical devices –
symbols to be used with
medical device labels,
labeling, and information
to be supplied – Part 1:
General requirements
ISO 15223-1:2016
Medical devices –
symbols to be used with
medical device labels,
labeling, and information
to be supplied – Part 1:
General requirements
EU MDR
ISO 15223-1:2016
Medical devices –
symbols to be used with
medical device labels,
labeling, and information
to be supplied – Part 1:
General requirements
ISO 15223-1:2016
Medical devices –
symbols to be used with
medical device labels,
labeling, and information
to be supplied – Part 1:
General requirements
Reference
Description
number
5.3.1
Indicates a medical
device that can be
broken or damaged if not
handled carefully
5.3.4
Indicates a medical
device that needs to be
protected from moisture
EU MDR
Indicates that the device
Annex I,
is a medical device
23.2 (q)
5.3.7
Indicates the
temperature limits to
which the medical device
can be safely exposed
5.3.9
Indicates the range of
atmospheric pressure to
which the medical device
can be safely exposed
Safety