10 Definition of symbols
The following table defines the symbols used in this document, on the product, and
on the product label.
EN ISO 7010: Graphical symbols — Safety colors and safety signs — Registered safety signs
Symbol/number
Name: Definition
General warning sign: To signify a general warning.
W001
EN ISO 15223-1: Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements
Symbol/number
Name: Definition
Manufacturer: Indicates the medical device manufacturer.
5.1.1
Date of manufacture: Indicates the date when the medical device was manufactured.
5.1.3
Consult instructions for use: Indicates the need for the user to consult the instructions for use.
5.4.3
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.
5.4.4
Batch code: Indicates the manufacturer's batch code so that the batch or lot can be identified.
LOT
5.1.5
Catalog number: Indicates the manufacturer's catalog number so that the medical device can be identified.
REF
5.1.6
Non-sterile: Indicates a medical device that has not been subjected to a sterilization process.
NON
STERILE
5.2.7
Temperature limit: Indicates the temperature limits to which the medical device can be safely exposed.
5.3.7
Humidity limitation: Indicates the range of humidity to which the medical device can be safely exposed.
5.3.8
Atmospheric pressure limitation: Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
5.3.9
Medical device: Indicates the item is a medical device.
5.7.7
21 CFR 801.109
Symbol
Name: Definition
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Rx Only
Product-specific symbols
Symbol
Name: Definition
Global Trade Item Number.
GTIN
ASTM F2503: Standard practice for marking medical devices and other items for safety in the MR environment
Symbol
Name: Definition
MR Unsafe: An item that poses unacceptable risks to the patient, medical staff, or other persons within the MR environment.
MR
Stryker
Definition of symbols
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