Symbols Glossary

 
 
 

Symbol/Statement Standard/Symbol Reference Number Title of Symbol Description of Symbol
ISO 15223-1,
Clause 5.1.6
Catalog number Indicates the manufacturer’s catalog number so that the medical device can be identified.
ISO 15223-1,
Clause 5.1.1
Manufacturer Indicates the medical device manufacturer.
ISO 15223-1,
Clause 5.1.5
Batch code Indicates the manufacturer’s batch code so that the batch or lot can be identified.
ISO 15223-1,
Clause 5.1.4
Use by date Indicates the date after which the medical device is not to be used.
IEC 60601-1, Table D.2, Symbol 2 General warning sign Indicates that caution is necessary when operating the device; the current situation needs operator awareness or operator action in order to avoid undesirable consequences.
IEC 60601-1, Table D.2, Symbol 10 Refer to instruction manual/booklet To signify that the instruction manual/booklet must be read
21 CFR 801.109 Prescription only Requires a prescription in the United States.
ISO 15223-1,
Clause 5.4.3
Consult Instructions for Use Indicates the need for the user to consult the instructions for use.
IEC 60529 / Degrees of protection provided by enclosures (IP Code) n/a Protected against fingers or objects › 12.55 mm and water spray less than 15° from the vertical.
ISO 15223-1,
Clause 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 15223-1,
Clause 5.4.2
Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
ISO 15223-1,
Clause 5.2.6
Do not resterilize Indicates a medical device that is not to be resterilized.
ISO 15223-1,
Clause 5.2.3
Sterilized by ethylene oxide Indicates a medical device that has been sterilized using ethylene oxide.
ISO 15223-1,
Clause 5.3.7
Temperature limit Indicates the temperature limits to which the medical device can be safely exposed.
IEC 60417,
Reference No. 5840
Type B Applied Part To identify a type B applied part complying with IEC 60601-1.
ISO 15223-1, Clause 5.2.7 Non-sterile Indicates a medical device that has not been subjected to a sterilization process.
Medical Device Directive 93/42/EEC, Medical Device Regulation 2017/745 CE marking ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with MDD 93/42/EEC or MDR 2017/745 and other applicable Union harmonisation legislation
ISO 15223-1, Clause 5.1.2 Authorized representative in the European Community Indicates the authorized representative in the European Community.
ISO 15223-1, Clause 5.7.7 Medical device Indicates the item is a medical device
Not made with natural rubber latex FDA Guidance, December 2, 2014 Indicates the product is not made with natural rubber latex
ISO 15223-1, Clause 5.1.8 Importer Indicates the entity importing the medical device into the locale
UK MDR 2002 UK Conformity Assessed Marking Indicates that a device is in conformity with UK MDR 2002