Symbols Glossary

Symbol/Statement Standard/Symbol Reference Number Title of Symbol Description of Symbol
Catalog number ISO 15223-1, Clause 5.1.6 Catalog number Indicates the manufacturer’s catalog number so that the medical device can be identified.
Manufacturer ISO 15223-1, Clause 5.1.1 Manufacturer Indicates the medical device manufacturer.
Batch code ISO 15223-1, Clause 5.1.5 Batch code Indicates the manufacturer’s batch code so that the batch or lot can be identified.
Use by date ISO 15223-1, Clause 5.1.4 Use by date Indicates the date after which the medical device is not to be used.
Country of manufacture (with date of manufacture adjacent) ISO 15223-1, Clause 5.1.11 Country of manufacture (with date of manufacture adjacent) Identifies the country of manufacture of products and indicates the date when the medical device was manufactured.
General warning sign 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.
Refer to instruction manual/booklet IEC 60601-1, Table D.2, Symbol 10 Refer to instruction manual/booklet To signify that the instruction manual/booklet must be read
Consult Instructions for Use ISO 15223-1, Clause 5.4.3 Consult Instructions for Use Indicates the need for the user to consult the instructions for use.
IP22 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.
Do not use if package is damaged 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.
Do not reuse 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.
Do not resterilize ISO 15223-1, Clause 5.2.6 Do not resterilize Indicates a medical device that is not to be resterilized.
Sterilized by ethylene oxide ISO 15223-1, Clause 5.2.3 Sterilized by ethylene oxide Indicates a medical device that has been sterilized using ethylene oxide.
Single sterile barrier system ISO 15223-1, Clause 5.2.11 Single sterile barrier system Indicates a single sterile barrier system
Temperature limit ISO 15223-1, Clause 5.3.7 Temperature limit Indicates the temperature limits to which the medical device can be safely exposed.
Type B Applied Part IEC 60417, Reference No. 5840 Type B Applied Part To identify a type B applied part complying with IEC 60601-1.
Medical device ISO 15223-1, Clause 5.7.7 Medical device Indicates the item is a medical device
Authorized representative in the European Community ISO 15223-1, Clause 5.1.2 Authorized representative in the European Community Indicates the authorized representative in the European Community.
CE marking 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
Importer ISO 15223-1, Clause 5.1.8 Importer Indicates the entity importing the medical device into the locale
Prescription only 21 CFR 801.109 Prescription only Requires a prescription in the United States.
UK Conformity Assessed Marking UK MDR 2002 UK Conformity Assessed Marking Indicates that a device is in conformity with UK MDR 2002
Non-sterile ISO 15223-1, Clause 5.2.7 Non-sterile Indicates a medical device that has not been subjected to a sterilization process.
Not made with natural rubber latex FDA Guidance, December 2, 2014 – Indicates the product is not made with natural rubber latex