16
Symbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-” 5.4.3 Consult instructions for use Indicates the need for the user to consult the instructions for use. ISO 7000 “Graphical symbols for use on equipment” 1641 IEC 60601-1 “Medical electronic equipment – Part 1: General requirements for basic safety and essential performance” Table D.1 11 IEC 60601-2-18 “Medical electronic equipment – Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment” 101 Endoscope Endoscope IEC 60417 “Graphical symbols for use on equipment” 5335 Type CF applied part To identify a type CF applied part complying with IEC 60601-1. IEC 60601-1 “Medical electronic equipment – Part 1: General requirements for basic safety and essential performance” Table D.1 21

Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

  • Upload
    others

  • View
    33

  • Download
    2

Embed Size (px)

Citation preview

Page 1: Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

Symbols Glossary Rev. 2 1 / 16

Symbol Standard Number / Standard Title

Reference Number

Symbol Title Symbol Explanatory

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.4.3 Consult instructions for use

Indicates the need for the user to consult the instructions for use.

ISO 7000 “Graphical symbols for use on equipment”

1641

IEC 60601-1 “Medical electronic equipment – Part 1: General requirements for basic safety and essential performance”

Table D.1 11

IEC 60601-2-18 “Medical electronic equipment – Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment”

101 Endoscope Endoscope

IEC 60417 “Graphical symbols for use on equipment”

5335 Type CF applied part

To identify a type CF applied part complying with IEC 60601-1.

IEC 60601-1 “Medical electronic equipment – Part 1: General requirements for basic safety and essential performance”

Table D.1 21

Page 2: Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

Symbols Glossary Rev. 2 2 / 16

Symbol Standard Number / Standard Title

Reference Number

Symbol Title Symbol Explanatory

IEC 60417 “Graphical symbols for use on equipment”

5333 Type BF applied part

To identify a type BF applied part complying with IEC 60601-1.

IEC 60601-1 “Medical electronic equipment – Part 1: General requirements for basic safety and essential performance”

Table D.1 20

IEC 60417 “Graphical symbols for use on equipment”

5840 Type B applied part

To identify a type B applied part complying with IEC 60601-1.

IEC 60601-1 “Medical electronic equipment – Part 1: General requirements for basic safety and essential performance”

Table D.1 19

IEC 60417 “Graphical symbols for use on equipment”

5336 Defibrillation-proof type CF applied part

To identify a defibrillation-proof type CF applied part complying with IEC 60601-1.

IEC 60601-1 “Medical electronic equipment – Part 1: General requirements for basic safety and essential performance”

Table D.1 27

IEC 60417 “Graphical symbols for use on equipment”

5041 Caution, hot surface

To indicate that the marked item can be hot and should not be touched without taking care.

Page 3: Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

Symbols Glossary Rev. 2 3 / 16

Symbol Standard Number / Standard Title

Reference Number

Symbol Title Symbol Explanatory

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.4.4 Caution Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

ISO 7000 “Graphical symbols for use on equipment”

0434A

IEC 60601-1 “Medical electronic equipment – Part 1: General requirements for basic safety and essential performance”

Table D.1 10

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.1.5 Batch code Indicates the manufacturer’s batch code so that the batch or lot can be identified.

ISO 7000 “Graphical symbols for use on equipment”

2492

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.1.7 Serial number Indicates the manufacturer’s serial number so that a specific medical device can be identified.

ISO 7000 “Graphical symbols for use on equipment”

2498

Page 4: Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

Symbols Glossary Rev. 2 4 / 16

Symbol Standard Number / Standard Title

Reference Number

Symbol Title Symbol Explanatory

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.1.6 Catalogue number

Indicates the manufacture’s catalogue number so that the medical device can be identified.

ISO 7000 “Graphical symbols for use on equipment”

2493

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.4.2 Do not re-use Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.

ISO 7000 “Graphical symbols for use on equipment”

1051

IEC 60601-1 “Medical electronic equipment – Part 1: General requirements for basic safety and essential performance”

Table D.1 28

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.1.4 Use-by date

Indicates the date after which the medical device is not to be used.

ISO 7000 “Graphical symbols for use on equipment”

2607

Page 5: Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

Symbols Glossary Rev. 2 5 / 16

Symbol Standard Number / Standard Title

Reference Number

Symbol Title Symbol Explanatory

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.2.4 Sterilized using irradiation

Indicates a medical device that has been sterilized using irradiation.

ISO 7000 “Graphical symbols for use on equipment”

2502

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.2.3 Sterilized using ethylene oxide

Indicates a medical device that has been sterilized using ethylene oxide.

ISO 7000 “Graphical symbols for use on equipment”

2501

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.2.5 Sterilized using steam or dry heat

Indicates a medical device that has been sterilized using steam or dry heat.

ISO 7000 “Graphical symbols for use on equipment”

2503

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.3.2 Keep away from sunlight

Indicates a medical device that needs protection from light sources.

ISO 7000 “Graphical symbols for use on equipment”

0624

Page 6: Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

Symbols Glossary Rev. 2 6 / 16

Symbol Standard Number / Standard Title

Reference Number

Symbol Title Symbol Explanatory

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.3.4 Keep dry Indicates a medical device that needs to be protected from moisture.

ISO 7000 “Graphical symbols for use on equipment”

0626

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.2.6 Do not resterilize

Indicates a medical device that is not to be resterilized.

ISO 7000 “Graphical symbols for use on equipment”

2608

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.2.7 Non-sterile Indicates a medical device that has not been subjected to a sterilization process.

ISO 7000 “Graphical symbols for use on equipment”

2609

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.4.5 Contains or presence of natural rubber latex

Indicates the presence of natural rubber or dry natural rubber latex as a material of construction within the medical device or the packaging of a medical device.

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.4.5* Not Made with Natural Rubber Latex

Indicates a medical device that does not contain natural rubber latex. *Annex B B.2 is applied to the reference number of symbol: 5.4.5

Page 7: Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

Symbols Glossary Rev. 2 7 / 16

Symbol Standard Number / Standard Title

Reference Number

Symbol Title Symbol Explanatory

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.2.8 Do not use if package is damaged

Indicates a medical device that should not be used if the package has been damaged or opened.

ISO 7000 “Graphical symbols for use on equipment”

2606

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.3.6 Upper limit of temperature

Indicates the upper limit of temperature to which the medical device can be safely exposed.

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.3.5 Lower limit of temperature

Indicates the lower limit of temperature to which the medical device can be safely exposed.

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.3.7 Temperature Limit

Indicates the temperature limits to which the medical device can be safely exposed.

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.1.1 Manufacturer

Indicates the medical device manufacturer.

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.1.2 Authorized representative in the European Community

Indicates the Authorized representative in the European Community.

Page 8: Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

Symbols Glossary Rev. 2 8 / 16

Symbol Standard Number / Standard Title

Reference Number

Symbol Title Symbol Explanatory

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.1.3 Date of manufacture

Indicates the date when the medical device was manufactured.

ISO 7000 “Graphical symbols for use on equipment”

2497

BS EN 15986 “Symbol for use in the labelling of medical devices – Requirements for labelling of medical devices containing phthalates”

Figure A.1

Contains or presence of phthalate (DEHP)

Contains or presence of phthalate: bis(2-ethylhexyl)phthalate (DEHP)

IEC 60601-1 “Medical electronic equipment – Part 1: General requirements for basic safety and essential performance”

Table D.2 10

Follow instructions for use

Follow instructions for use

IEC 60601-1 “Medical electronic equipment – Part 1: General requirements for basic safety and essential performance”

Table D.2 2

General warning sign

General warning sign

IEC 60601-1 “Medical electronic equipment – Part 1: General requirements for basic safety and essential performance”

Table D.2 9

General mandatory action sign

General mandatory action sign

IEC 60417 “Graphical symbols for use on equipment”

5032 Alternating current

To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals.

Page 9: Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

Symbols Glossary Rev. 2 9 / 16

Symbol Standard Number / Standard Title

Reference Number

Symbol Title Symbol Explanatory

IEC 60417 “Graphical symbols for use on equipment”

5021 Equipoten- tiality

To identify the terminals which, when connected together, bring the various parts of an equipment or of a system to the same potential, not necessarily being the earth (ground) potential, e.g. for local bonding.

IEC 60601-1 “Medical electronic equipment – Part 1: General requirements for basic safety and essential performance”

Table D.1 8

IEC 60417 “Graphical symbols for use on equipment”

5140 Non-ionizing electromagnetic radiation

To indicate generally elevated, potentially hazardous, levels of non-ionizing radiation, or to indicate equipment or systems e.g. in the medical electrical area that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment.

IEC 60601-1 “Medical electronic equipment – Part 1: General requirements for basic safety and essential performance”

Table D.3 2

Ingress protection rating is 7.

Protected against the effects of temporary immersion in water.

IEC 60417 “Graphical symbols for use on equipment”

5134 Electrostatic sensitive devices

To indicate packages containing electrostatic sensitive devices, or to identify a device or a connector that has not been tested for immunity to electrostatic discharge.

IEC 60417 “Graphical symbols for use on equipment”

5010 “ON”/”OFF” (push-push)

To indicate connection to or disconnection from the mains, at least for mains switches or their positions, and all those cases where safety is involved.

Page 10: Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

Symbols Glossary Rev. 2 10 / 16

Symbol Standard Number / Standard Title

Reference Number

Symbol Title Symbol Explanatory

IEC 60417 “Graphical symbols for use on equipment”

5007 “On” (power) To indicate connection to the mains, at least for mains switches or their positions, and all those cases where safety is involved.

IEC 60417 “Graphical symbols for use on equipment”

5008 “Off” (power) To indicate disconnection from the mains, at least for mains switches or their positions, and all those cases where safety is involved.

IEC 60417 “Graphical symbols for use on equipment”

5104 Start; start of action

To identify the start button.

IEC 60417 “Graphical symbols for use on equipment”

5558 White balance To identify the controls that adjust the white balance.

IEC 60417 “Graphical symbols for use on equipment”

5056 Brightness; brilliance

To identify the brightness control.

IEC 60417 “Graphical symbols for use on equipment”

5016 Fuse To identify fuse boxes or their location.

IEC 60417 “Graphical symbols for use on equipment”

5511 Menu To identify the control by which the menu (availability of options) can be displayed.

IEC 60417 “Graphical symbols for use on equipment”

5525A Video input To identify video equipment input controls and connecting terminals.

IEC 60417 “Graphical symbols for use on equipment”

5529A Video output To identify video equipment output controls and connecting terminals.

Page 11: Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

Symbols Glossary Rev. 2 11 / 16

Symbol Standard Number / Standard Title

Reference Number

Symbol Title Symbol Explanatory

ISO 7000 “Graphical symbols for use on equipment”

0018 Lock; tighten Lock or tighten.

ISO 7000 “Graphical symbols for use on equipment”

0019 Unlock; unclamp

Unlock or unclamp.

IEC 60417 “Graphical symbols for use on equipment”

5114 Foot switch To identify a foot switch or the connection for a foot switch.

IEC 60417 “Graphical symbols for use on equipment”

5017 Earth; ground To identify an earth (ground) terminal.

IEC 60417 “Graphical symbols for use on equipment”

5264 “ON” for a part of equipment

To indicate the “ON” condition for a part of equipment.

IEC 60417 “Graphical symbols for use on equipment”

5265 “OFF” for a part of equipment

To indicate the “OFF” condition for a part of equipment.

IEC 60417 “Graphical symbols for use on equipment”

5034 Input To indicate an input terminal.

IEC 60417 “Graphical symbols for use on equipment”

5035 Output To indicate an output terminal.

IEC 60417 “Graphical symbols for use on equipment”

5220 Short-circuit- proof transformer

To identify a transformer which can withstand a short-circuit, inherently or non-inherently.

Page 12: Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

Symbols Glossary Rev. 2 12 / 16

Symbol Standard Number / Standard Title

Reference Number

Symbol Title Symbol Explanatory

IEC 60417 “Graphical symbols for use on equipment”

5002 Position of cell On and in battery holders.

EN 50419 “Marking of electrical and electronic equipment in accordance with article 11(2) of Directive 2002/96/EC (WEEE)”

NA Crossed-out wheeled bin

To indicate that the product shall be separated when disposal.

BS EN ISO 780 “Packaging. Distribution packaging. Graphical symbols for handling and storage of packages”

3 Fragile, handle with care

Contents of the distribution packages are fragile therefore it shall be handled with care.

ISO 7000 “Graphical symbols for use on equipment”

0621

BS EN ISO 780 “Packaging. Distribution packaging. Graphical symbols for handling and storage of packages”

13 This way up This is the correct upright position of the distribution packages for transport and/or storage.

ISO 7000 “Graphical symbols for use on equipment”

0623

Page 13: Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

Symbols Glossary Rev. 2 13 / 16

Symbol Standard Number / Standard Title

Reference Number

Symbol Title Symbol Explanatory

BS EN ISO 780 “Packaging. Distribution packaging. Graphical symbols for handling and storage of packages”

16 Stacking limit by number

Maximum number of identical transport packages/items which may be stacked on the bottom package, where “n” is the limiting number.

ISO 7000 “Graphical symbols for use on equipment”

2403

BS EN ISO 780 “Packaging. Distribution packaging. Graphical symbols for handling and storage of packages”

17 Do not stack Stacking of the distribution packages is not allowed and no load shall be placed on the distribution packages.

ISO 7000 “Graphical symbols for use on equipment”

2402

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.6.6 One-way valve Indicates a medical device with a valve that allows flow in only one direction.

ISO 7000 “Graphical symbols for use on equipment”

2728

Page 14: Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

Symbols Glossary Rev. 2 14 / 16

Symbol Standard Number / Standard Title

Reference Number

Symbol Title Symbol Explanatory

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.3.8 Humidity limitation

Indicates the range of humidity to which the medical device can be safely exposed.

ISO 7000 “Graphical symbols for use on equipment”

2620

ISO 15223-1 “Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-”

5.3.9 Atmospheric pressure limitation

Indicates the range of atmospheric pressure to which the medical device can be safely exposed.

ISO 7000 “Graphical symbols for use on equipment”

2621

ISO 7010 “Graphical symbols – Safety colours and safety signs – Registered safety signs”

ISO 7010-P001

General prohibition sign

To signify a prohibited action.

IEC 60417 “Graphical symbols for use on equipment”

5009 Stand-by To identify the switch or switch position by means of which part of the equipment is switched on in order to bring it into the stand-by condition.

IEC 60417 “Graphical symbols for use on equipment”

5012 Lamp; lighting; illumination

To identify switches which control light sources.

Page 15: Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

Symbols Glossary Rev. 2 15 / 16

Symbol Standard Number / Standard Title

Reference Number

Symbol Title Symbol Explanatory

IEC 60417 “Graphical symbols for use on equipment”

5110B Stop To identify the control or the indicator to stop the active function.

IEC 60417 “Graphical symbols for use on equipment”

5147 Adjustment to a maximum

To identify the control by means of which a quantity is adjusted to its maximum value.

IEC 60417 “Graphical symbols for use on equipment”

5181 Variability in steps

To identify the device by which a quantity is controlled.

IEC 60417 “Graphical symbols for use on equipment”

5184 Clock; time switch; timer

To identify terminals and controls related to clocks, time switches and timers.

IEC 60417 “Graphical symbols for use on equipment”

5323 Iris diaphragm, open

To identify the control for opening the iris diaphragm or to indicate the open state.

IEC 60417 “Graphical symbols for use on equipment”

6188 Air impeller, feeding

To identify the switch or control which operates the air impeller for air feeding.

ISO 7000 “Graphical symbols for use on equipment”

0017 Automatic control (closed loop)

To indicate any automatic closed loop function.

ISO 7000 “Graphical symbols for use on equipment”

0033 Suction To indicate the generation of an air current by the use of suction (for example, for the removal of dust or particulate matter, or lifting of light material (such as paper) by suction).

Page 16: Symbols Glossary Rev. 2 1 / 16 - OLYMPUS : GlobalSymbols Glossary Rev. 2 1 / 16 Symbol Standard Number / Standard Title Reference Number Symbol Title Symbol Explanatory 5.4.3 Consult

Symbols Glossary Rev. 2 16 / 16

Symbol Standard Number / Standard Title

Reference Number

Symbol Title Symbol Explanatory

ISO 7000 “Graphical symbols for use on equipment”

0096 Manual control To identify a manually operated control. To identify the switch position that places the equipment under manual (as opposed to automatic) control. To identify the control that activates manual control. To indicate that the equipment is in manual control mode.

ASTM F2503 “Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment ”

FIG. 6 MR Conditional To identify an item with demonstrated safety in the MR environment within defined conditions.

ISO 7000 “Graphical symbols for use on equipment”

0421 Examine; check To indicate examination or checking.

IEC 60417 “Graphical symbols for use on equipment”

5184 Clock; time switch; timer

To identify terminals and controls related to clocks, time switches and timers.