Glossary Of Symbols - natus Nicolet EDX Instructions For Use Manual

Glossary of Symbols:

Standard
Symbol
Reference
Not applicable Not applicable
21 CFR Part
801.109(b)(1)
ISO 15223-1
Symbol 5.4.5
(Reference
Annex B for
the general
prohibition
symbol)
2012/19/EU
ISO 15223-1
Symbol 5.1.1
ISO 15223-1
Symbol 5.1.2
ISO 15223-1
Symbol 5.1.3
ISO 15223-1
Symbol 5.1.5
ISO 15223-1
Symbol 5.1.6
ISO 15223-1
Symbol 5.4.3
Annex A
#A.15
Standard Title
Labeling-Prescription
devices
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 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
Page 5 of 6
Symbol Title
An indication of This product is a medical device.
Medical Device
Prescription only Indicates that the product is
authorized for sale by or on the
order of a licensed healthcare
practitioner.
Not made with natural Indicates that the medical device is
rubber latex not made with natural rubber latex.
Disposal at end of Indicates that electrical and
operating life electronic equipment waste should
instructions not be discarded together with
unseparated waste but must be
collected separately.
Manufacturer Indicates the medical device
manufacturer.
Authorized Indicates the Authorized
representative in the representative in the European
European Community Community.
Date of manufacture Indicates the date when the
medical device was manufactured.
Batch code Indicates the manufacturer's batch
code so that the batch or lot can
be identified.
Catalogue number Indicates the manufacturer's
catalogue number so that the
medical device can be identified.
Consult instructions for Indicates an instruction to consult
use an electronic instructions for use
(eIFU).
Explanation