20
ICS Aircal
ICS Aircal system safety
6.1
Glossary of symbol
Symbol
Standard
Reference
Standard Title of Symbol
Symbol Title
as per
Referenced
Standard
Explanation
N/A
N/A
An indication of
Medical Device
This product is a medical
device.
XXXX
Directive
93/42/EEC
MDR
2017/745
Medical Device Directive
EU Medical Device
Regulation
CE marking
Signifies European technical
conformity.
(Notified body number
appears under symbol.)
21 CFR
801.109(b)(1)
Labeling-Prescription
devices
Prescription
only
Indicates that the product is
authorized for sale by or on
the order of a licensed
healthcare practitioner.
N/A
N/A
Quantity
Number of parts in a
package.
Directive
2012/19/EU
Waste Electrical and
Electronic Equipment (WEEE)
Disposal at end
of operating life
instructions
Indicates that electrical and
electronic equipment waste
should not be discarded
together with unseparated
waste but must be
collected separately.
ISO 15223-
1:2016
Reference no.
5.1.1 (ISO
7000-3082)
Medical devices — Symbols
to be used with medical
device labels, labeling and
information to be supplied
Manufacturer
Indicates the medical
device manufacturer.
ISO 15223-
1:2016
Reference no.
5.1.3. (ISO
7000-2497)
Medical devices — Symbols
to be used with medical
device labels, labeling and
information to be supplied –
Part 1: General
requirements.
Date of
manufacture
Indicates the date when the
medical device was
manufactured.
ISO 15223-1
Reference no.
5.1.5
Medical devices — Symbols
to be used with medical
device labels, labeling and
information to be supplied.
Batch code or
Lot code
Indicates the
manufacturer's batch code
so that the batch or lot can
be identified.
ISO 15223-1
Reference no.
5.1.6
Medical devices — Symbols
to be used with medical
device labels, labeling and
information to be supplied.
Catalogue
number
Indicates the
manufacturer’s catalogue
number so that the medical
device can be identified.
