Symbol
Standard Reference
Standard Title
Symbol Title
Explanatory Text
ISO 7010 Second Edi-
tion 2011-06-01, P007
Graphical Symbols –
Safety Colours And
Safety Signs – Reg-
istered Safety Signs
[Including AMEND-
MENT 1 (2012)
Through AMEND-
MENT 7 (2016)]
Not for persons
with pacemakers
or implanted
defibrillators
The device must never
be used by persons
with cardiac pace-
makers or other active
medical implants. In
this connection, also
observe the contraindi-
cations.
765/2008/EC
768/2008/EC MDD
93/42/EEC Articles
4,11,12,17, Annex II )
The requirements for
accreditation and
market surveillance
relating to the mar-
keting of products;
Medical Device
Directive.
CE marking
Signifies European
technical conformity.
21 CFR 801.109
Labeling-Prescription
devices.
Prescription only
Requires prescription
in the United States.
EN 50419
Marking of Electrical
and Electronic Equip-
ment in accordance
with Article 11(2) of
Directive 2002/96/EC
(WEEE).
Recycle: Elec-
tronic Equipment
Waste of electrical and
electronic equipment
(WEEE). Electrical and
electronic parts may
contain toxic materials.
These parts must be
collected separately
and turned in at com-
munal collection points,
or disposed of by a
specialist company.
ISO 15223-1 Third
Edition 2016-11-01
Clause 5.1.5
Medical Devices -
Symbols To Be Used
With Medical Device
Labels, Labelling,
And Information To
Be Supplied – Part 1:
General Require-
ments
Batch code
Indicates the manufac-
turer's batch code so
that the batch or lot can
be identified.
ES60601-1:2005/
(R)2012 And A1:2012,
Table D.3, Symbol 2
Medical electrical
equipment – Part 1:
General require-
ments for basic
safety and essential
performance.
Degree of
Ingress Protec-
tion Provided by
Enclosure
Manufacturer-deter-
mined degree of par-
ticle and water ingress
protection, where...
N1= degree of protec-
tion from particulates
(scale of 0 – 6); and
N2 = degree of protec-
tion from water (scale
of 0 – 8)
Safety
2021-07-28
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