Watson Health Imaging Symbols Glossary

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Watson Health Imaging Symbols Glossary

The Symbols Glossary describes all symbols that may be found on the labeling and packaging of Watson Health Imaging medical devices.
Symbol Symbol Title
Reference
Number
 Description Standard Title and Designation Number
image 5606 Manufacturer 5.1.1 Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC and EU MDR 2017/745 ISO 15223-1 Medical devices - Symbols to be used with medical device labels - General Requirements
image 5607 Date of manufacture. 5.1.3 Indicates the date when the medical device was manufactured ISO 15223-1 Medical devices - Symbols to be used with medical device labels - General Requirements
image 5608 Authorized Representative in the European Community / European Union 5.1.2 Indicates the Authorized Representative in the European Community ISO 15223-1 Medical devices - Symbols to be used with medical device labels - General Requirements
UK REP Authorized Representative in the United Kingdom 5.1.2 Indicates the Authorized Representative in the United Kingdom ISO 15223-1 Medical devices - Symbols to be used with medical device labels - General Requirements
image 5610 Part or Catalog number 5.1.6 Indicates the manufacturer's catalog number so that the medical device can be identified ISO 15223-1 Medical devices - Symbols to be used with medical device labels - General Requirements
image 5611 Batch Code 5.1.5 Indicates the manufacturer's batch code so that the batch or lot can be identified ISO 15223-1 Medical devices - Symbols to be used with medical device labels - General Requirements
image 5612 Serial number 5.1.7 Indicates the manufacturer's serial number so that the medical device can be identified ISO 15223-1 Medical devices - Symbols to be used with medical device labels - General Requirements
image 5613 Medical Device 5.7.7 Indicates the labeled product is a medical device MDR 2017/745 – Art. 18 - §1d
Country of manufacture Country of manufacture 6049 Identifies the country of manufacture of products. ISO 7000 / IEC 60417 Graphical symbols for use on equipment
image 5615
or
image 5616		 WEEE Waste of Electrical and Electronic Equipment N/A Indicates that when end user wishes to discard this product it must be sent to separate sent to separate collection facilities for recovery and recycling in the EU BS EN 50419:2006 Marking of Electrical Equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE)
image 5617 United Kingdom Conformity N/A Equivalent to the EU CE marking.  CE marking on a product is a manufacturer's declaration that the product complies with essential requirements of the relevant European health, safety and environmental protection legislation. Directive 93/68/EEC CE Marking Directive
EU Medical Device Regulation 2017/745
image 5619 CE marking N/A CE marking on a product is a manufacturer's declaration that the product complies with essential requirements of the relevant European health, safety and environmental protection legislation. Directive 93/68/EEC CE Marking Directive
EU Medical Device Regulation 2017/745
image 5619
1639
 CE marking with Notified Body N/A CE marking on a product is a manufacturer's declaration that the product complies with essential requirements of the relevant European health, safety and environmental protection legislation. Directive 93/68/EEC CE Marking Directive
EU Medical Device Regulation 2017/745
image 5620 US Symbol for prescription only medical devices. N/A
The symbol for Prescription Device
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
 21 CFR 801.109
image 5622 Consult Instructions for Use 5.4.3 Indicates the need for the user to consult the instructions for use. ISO 15223-1 Medical devices - Symbols to be used with medical device labels - General Requirements
image 5622 Consult Electronic Instructions for Use 5.4.3 Indicates the need for the user to consult the electronic instructions for use (eIFU) at the specified website location. ISO 15223-1 Medical devices - Symbols to be used with medical device labels - General Requirements
image 5623 Refer to instruction Manual/booklet ISO 7010-M002 Indicates that the instruction manual / booklet must be read IEC/TR 60878 Graphical symbols for electrical equipment in medical practice
image 5624 EU Importer 3725 Indicates the entity importing the medical device into the locale ISO 7000 / IEC 60417 Graphical symbols for use on equipment
image 5625 Temperature Limit 5.3.7 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 - General Requirements
image 5626 Humidity Limitation 5.3.8 Indicates the range of the humidity to which the medical device can be safely exposed ISO 15223-1 Medical devices - Symbols to be used with medical device labels - General Requirements
image 5627 Atmospheric Pressure limitation 5.3.9 Indicates the range of atmospheric pressure to which the medical device can be safety exposed ISO 15223-1 Medical devices - Symbols to be used with medical device labels - General Requirements
image 5628 Keep Dry 5.3.4 Indicates a medical device that needs to be protected from moisture ISO 15223-1 Medical devices - Symbols to be used with medical device labels - General Requirements
image 5629 Caution 5.4.4 Indicates that 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 15223-1 Medical devices - Symbols to be used with medical device labels - General Requirements
image 5630 Warning: Electricity ISO 7010- W012 Warns of electricity ISO 7000 / IEC 60417 Graphical symbols for use on equipment
image 5632 Equipotentiality 5021 Identifies the terminals which, when connected together, bring the various parts of an equipment or of a system to the same potential, no necessarily being the earth (ground) potential, e.g., for local bonding ISO 7000 / IEC 60417 Graphical symbols for use on equipment
image 5635 Current 5032 Indicates on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals ISO 7000 / IEC 60417 Graphical symbols for use on equipment
Fuse Fuse 5016 Identifies fuse boxes or their locations ISO 7000 / IEC 60417 Graphical symbols for use on equipment
image 5634 Standby 5009 Identifies 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 ISO 7000 / IEC 60417 Graphical symbols for use on equipment
image 5636 ON/OFF (push/push) 5010 Indicates disconnection form the mains, at least for main switches, or their positions, and all those cases where safety is involved. Each position, “ON” or “OFF” is a stable position ISO 7000 / IEC 60417 Graphical symbols for use on equipment
image 5637 Type CF defibrillation - proof patient applied part 5021 Identifies a defibrillation-proof CF applied part complying with IEC 60601-1 ISO 7000 / IEC 60417 Graphical symbols for use on equipment
image 5638 Battery Pack 5001B Identifies a device related to the power supply by primary or secondary battery, for instance a cover for the battery compartment, or the connector terminals ISO 7000 / IEC 60417 Graphical symbols for use on equipment
image 5639 Protective earth, protective ground 5032 Identifies any terminal which is intended for connection to an external conductor for protection against electrical shock in case of fault, or the terminal of a protective earth (ground) electrode ISO 7000 / IEC 60417 Graphical symbols for use on equipment
image 5640 Electrostatic sensitive devices 5134 Identifies packages containing electrostatic sensitive devices, or to identify a device or a connector that has not been tested for immunity to electrostatic discharge ISO 7000 / IEC 60417 Graphical symbols for use on equipment
image 5641 Type B applied part 5840 Identifies a type B applied part complying with IEC 60601-1 ISO 7000 / IEC 60417 Graphical symbols for use on equipment
image 5642 Non-ionizing  electromagnetic radiation 5140 Indicates generally elevated, potentially hazardous, levels of non- ionizing radiation, or to indicate equipment or systems e.g., that intentionally apply RF electromagnetic for diagnosis or treatment ISO 7000 / IEC 60417 Graphical symbols for use on equipment

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