REF 9508-004-01-ENG Rev A1
PRODUCT SYMBOLS
GLOSSARY
Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A.
1
Copyright © 2016
by Mortara Instrument, Inc.
7865 N. 86th Street
Milwaukee, Wisconsin 53224
This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document
may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written
consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc.
2
TABLE OF CONTENTS
PACKAGING SYMBOLS ........................................................................................................................................... 4 SAFETY SYMBOLS ................................................................................................................................................... 8 3
PACKAGING SYMBOLS
Symbol
Mortara Description
SDO Title, Ref. No.,
Standard
Mortara Ref No.
This Side Up
(used in accordance with ISO
780)
This way up
Ref. No. 13
ISO 780
Packaging – Distribution
packaging- Graphical symbols
for handling and storage of
packages
9011-004-02
Keep Dry
Ref. No. 5.3.4
ISO 15223-1:2012
Medical devices- symbols to be
used with medical device labels,
labeling and information to be
supplied – Part 1: General
Requirements
9011-004-03
Humidity Limitation
Ref. No. 5.3.8
ISO 15223-1:2012
Medical devices- symbols to be
used with medical device labels,
labeling and information to be
supplied – Part 1: General
Requirements
9011-016-43
Temperature Limit
Ref. No. 5.3.7
ISO 15223-1:2012
Medical devices- symbols to be
used with medical device labels,
labeling and information to be
supplied – Part 1: General
Requirements
9011-016-42
Keep Away from Heat
(used in accordance with ISO
15223-1)
Keep Away From Sunlight
Ref. No. 5.3.2
ISO 15223-1:2012
Medical devices- symbols to be
used with medical device labels,
labeling and information to be
supplied – Part 1: General
Requirements
9011-004-04
Fragile
(used in accordance with ISO
15223-1)
Fragile, Handle with Care
Ref. No. 5.3.1
ISO 15223-1:2012
Medical devices- symbols to be
used with medical device labels,
labeling and information to be
supplied – Part 1: General
Requirements
9011-004-06
Keep Dry
“Rel.” text is in reference to
relative humidity specification
(used in accordance with ISO
15223-1)
Indicates Acceptable Relative
Humidity
XXXX is generic placeholder
for specified percentages
(used in accordance with ISO
15223-1)
Acceptable Temperature
Range
XX is generic placeholder for
specified temperatures
(used in accordance with ISO
15223-1)
4
Symbol
Mortara Description
SDO Title, Ref. No.,
Standard
Mortara Ref No.
Federal Law restricts this
device to sale by or on the
order of a licensed health
practitioner
FDA Guidance for Industry:
Alternative to Certain
Prescription Device Labeling
Requirements
9011-016-24
Use By Date
Ref. No. 5.1.4
ISO 15223-1
Medical devices- symbols to be
used with medical device labels,
labeling and information to be
supplied – Part 1: General
Requirements
9011-015-81
Batch Code
Ref. No. 5.1.5
ISO 15223-1
Medical devices- symbols to be
used with medical device labels,
labeling and information to be
supplied – Part 1: General
Requirements
9011-015-82
Non-sterile
Ref. 5.2.7
ISO 15223-1
Medical devices- symbols to be
used with medical device labels,
labeling and information to be
supplied – Part 1: General
Requirements
9011-016-19
Recycle Li-ion
None
9011-016-21
#7 Recycling Classification
None
Indicates Device Manufacturer
Includes name and address of
the manufacturer
(used in accordance with ISO
15223-1)
Manufacturer
Ref. No. 5.1.1
ISO 15223-1
Medical devices- symbols to be
used with medical device labels,
labeling and information to be
supplied – Part 1: General
Requirements
Use By Date
YYYY-MM-DD is generic
placeholder
for specified Use By Date
(used in accordance with ISO
15223-1)
Date Code
(used in accordance with ISO
15223-1)
Non-Sterile
(used in accordance with ISO
15223-1)
9011-004-07
9011-015-99
5
Symbol
Mortara Description
SDO Title, Ref. No.,
Standard
Mortara Ref No.
Manufacturer Build Date
(used in accordance with ISO
15223-1)
Date of Manufacture
Ref. No. 5.1.3
ISO 15223-1
Medical devices- symbols to be
used with medical device labels,
labeling and information to be
supplied – Part 1: General
Requirements
9011-016-23
No PVC
None
9011-016-28
Does not contain natural
rubber latex
(used in accordance with FDA
Recommendations for
Labeling Medical Products to
Inform Users that the Product
or Product Container is not
Made with Natural Rubber
Latex)
Does not contain or have
presence of natural rubber latex
Ref. No. 5.4.5 &
Annex B.2 Negation Symbol
ISO 15223-1
Medical devices- symbols to be
used with medical device labels,
labeling and information to be
supplied – Part 1: General
Requirement
Does not contain latex
ISO 15223-1
Annex B.1 General Prohibition
Symbol
Medical devices- symbols to be
used with medical device labels,
labeling and information to be
supplied – Part 1: General
Requirement
9011-016-27
None
(used in accordance with ISO
15223-1)
Authorized representative in the
European Community
Ref. No. 5.1.2
ISO 15223-1
Medical devices- symbols to be
used with medical device labels,
labeling and information to be
supplied – Part 1: General
Requirements
9011-016-07
Catalog Number
(used in accordance with ISO
15223-1)
Catalog Number
Ref. No. 5.1.6
ISO 15223-1:
Medical devices- symbols to be
used with medical device labels,
labeling and information to be
supplied – Part 1: General
Requirements
9011-016-08
Authorized EC Representative
6
Symbol
Mortara Description
SDO Title, Ref. No.,
Standard
Mortara Ref No.
Separate Collection
(used in accordance with
Waste Electrical and Electronic
Equipment Act)
Separate Collection
Annex IV
Waste Electrical and Electronic
Equipment (WEEE)
Directive 2002/96/EC of the
European Parliament
9011-015-94
Do not Re-use
Ref. No. 5.4.2
ISO 15223-1
Medical devices- symbols to be
used with medical device labels,
labeling and information to be
supplied – Part 1: General
Requirements
9011-015-80
Do Not Reuse
(used in accordance with ISO
15223-1)
7
SAFETY SYMBOLS
Symbol
Description
SDO Title, Ref. No.,
Standard
Mortara Ref No.
Indicates Alternating Current
(used in accordance with IEC
60601-1)
Alternating Current
Ref. No. D.1-1
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-02
Indicates CF/Defib-Proof
Equipment
(used in accordance with IEC
60601-1)
Defibrillation-proof Type CF
Applied Part
Ref. No. D.1-27
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-06
Indicates Type “B” Equipment
(used in accordance with IEC
60601-1)
Type B Applied Part
Ref. No. D.1-19
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-32
Indicates Type “BF” Equipment
(used in accordance with IEC
60601-1)
Type BF Applied Part
Ref. No. D.1-20
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-89
Defibrillator Proof BF
Equipment
(used in accordance with IEC
60601-1)
Defibrillation-proof Type BF
Applied Part
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-88
8
Symbol
Description
Indicates CAUTION unless
used with one of following
other captions:
DANGER: indicates a
hazardous situation which, if
not avoided, will result in death
or serious injury
WARNING: indicates a
hazardous situation which, if
not avoided, could result in
death or serious injury
CAUTION: indicates a
hazardous situation which, if
not avoided, could result in
minor or moderate injury
(used in accordance with IEC
60601-1 and ANSI Z535.5)
=
XXX
kg
SDO Title, Ref. No.,
Standard
Caution
Ref. No. D.1-10
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
Mortara Ref No.
9011-015-01
When used on a patient
applied part, this symbol
indicates defibrillation
protection is in the cables
(used in accordance with IEC
60601-1:2012 Cl. 7.2.10)
General Warning Sign
Ref. No. D.2-1
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-016-32
Follow Instructions for Use
(used in accordance with IEC
60601-1)
Refer to instruction manual/
booklet
Ref. No. D.2-10
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-016-09
Consult Instructions For Use
(used in accordance with IEC
60601-1)
Operating Instructions
Ref. No. D.1-10
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-016-22
Equipment mass including
safe working load
XXX indicates specified weight
(used in accordance with IEC
60601-1, Cl. 7.2.21)
None
9011-016-36
9
Symbol
Description
SDO Title, Ref. No.,
Standard
Mortara Ref No.
Serial Number
(used in accordance with ISO
15223-1)
Serial Number
Ref. No. 5.1.7
ISO 15223-1
Medical devices- symbols to be
used with medical device
labels, labeling and information
to be supplied – Part 1: General
Requirements
9011-016-33
ON/OFF (Power/Stand-by)
(used in accordance with IEC
60601-1)
Stand-by
Ref. No. D.1-29
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-65
On/Off (push button)
(used in accordance with IEC
60601-1)
“ON” / “OFF” (push-push)
Ref. No. D.1-14
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-57
Both Direct & Alternating
Current
(used in accordance with IEC
60601-1)
Both direct and alternating
current
Ref. No. D.1-5
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-35
Protective Earth (Ground)
(used in accordance with IEC
60601-1)
Protective earth (ground)
Ref. No. D.1-6
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-03
Earth (Ground)
(used in accordance with IEC
60601-1)
Earth (ground)
Ref. No. D.1-7
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-10
10
Symbol
Description
SDO Title, Ref. No.,
Standard
Mortara Ref No.
Equipotentiality
(used in accordance with IEC
60601-1)
Equipotentiality
Ref. No. D.1-8
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-11
On (Power)
(used in accordance with IEC
60601-1)
“ON” (power)
Ref. No. D.1-12
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-14
Off(Power)
(used in accordance with IEC
60601-1)
“OFF” (power)
Ref. No. D.1-13
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-15
Partial On
(used in accordance with IEC
60601-1)
“ON” for part of equipment
Ref. D.1-16
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-16
Partial Off
(used in accordance with IEC
60601-1)
“OFF” for part of the equipment
Ref. No. D.1-17
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-17
Direct Current
(used in accordance with IEC
60601-1)
Direct Current
Ref. No. D.1-4
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-36
Dangerous Voltage
Ref. No. D.1-24
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-83
Electrical Shock
(used in accordance with IEC
60601-1)
11
Symbol
Description
SDO Title, Ref. No.,
Standard
Mortara Ref No.
No Alarms
(used in accordance with IEC
60601-1-8)
Alarm inhibit
Ref. No. C.1-3
IEC 60601-1-8
Medical electrical equipmentPart 1-8: General requirements
for basic safety and essential
performance- Collateral
standard: General
requirements, tests and
guidance and alarm systems in
medical electrical equipment
and medical electrical systems
9011-015-96
Class II Equipment
(used in accordance with IEC
60601-1)
Class II Equipment
Ref. No. D.1-9
IEC 60601-1
Medical Electrical EquipmentPart 1: General requirements
for basic safety and essential
performance
9011-015-37
12