Device Symbols - natus Madsen AccuScreen User Manual

1.12 Glossary of Symbols
Symbol Standard Reference
93/42/EEC
XXXX
21 CFR
801.109(b)(1)
Rx only
UL Listing
IEC 60417
Table D.1 #20
IEC 60601-1,
Table D.2 #10
ISO 15223-1, Symbol
5.4.3
2012/19/EU
ISO 15223-1
Symbol 5.2.8
ISO 15223-1, Clause
5.2.7
ISO 15223-1
Symbol 5.4.2
IEC 60601-1,
Table D.1 #4
Not applicable
Madsen AccuScreen OAE & ABR Screener User Manual
Standard Title
EU Medical Device Regulation
Medical Device Directive
Labeling-Prescription devices
N/A
Medical electrical equipment — Part 1:
General requirements for basic safety
and Essential performance
Medical electrical equipment – Part 1:
General requirements for basic safety
and essential performance
Medical devices – Symbols to be used
with medical device labels, labelling,
and information to be supplied
Waste Electrical and Electronic
Equipment (WEEE)
Medical devices – Symbols to be used
with medical device labels, labelling,
and information to be supplied
Medical devices — Symbols to be used
with medical device labels, labelling and
information to be supplied
Medical devices – Symbols to be used
with medical device labels, labelling,
and information to be supplied
Medical electrical equipment — Part 1:
General requirements for basic safety
and Essential performance
Not applicable
CE marking
Prescription only
N/A
Type BF applied
part
Follow instructions
for use
Consult instructions
for use
Disposal at the end
of operating life
instructions
Do not use if
package
is damaged
Non sterile
Do not re-use
Direct current
An indication of
Medical Device
9
Symbol Title Explanation
Signifies European
technical conformity.
(Notified body
number appears
under symbol.)
Indicates that the
product is authorized
for sale by or on the
order of a licensed
healthcare
practitioner.
Nationally
Recognized
Testing Laboratories
(NRTL) certifications
Identifies a type BF
applied part
complying with IEC
60601-1.
Refer to instruction
manual/Booklet.
NOTE on ME
EQUIPMENT
"Follow Instructions
for use".
Indicates the need
for the user to
consult the
instructions for use.
Indicates that
electrical and
electronic equipment
waste should not be
discarded together
with unseparated
waste but must be
collected separately.
Indicates that the
medical device
should not be used if
the package has
been damaged or
opened.
Indicates that the
medical device that
has not been
subjected to a
sterilization process.
Indicates that the
medical device is
intended for one
use, or for use on a
single patient during
a single procedure.
Indicates on the
rating plate that the
equipment is
suitable for direct
current only; to
identify relevant
terminals.
This product is a
medical device.