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Glossary

Symbol Symbol Title Reference number Description Standard Title and Designation number
icon Manufacturer 5.1.1
(ISO 7000 No 3082)
Indicates the medical device manufacturer, as defined in EU directives 90/385/EEC, 93/42/EEC and 98/79/EEC ISO &ANSI/AAMI ISO 15223-1:2012
Medical devices ñSymbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements
icon Catalogue number 5.1.6
(ISO 7000 No 2493)
The manufacturerís catalogue number so that the medical device can be identified ISO &ANSI/AAMI ISO 15223-1:2012
Medical devices ñSymbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements
icon Batch code 5.1.5
(ISO 7000 2492)
Indicates the manufacturerís batch code so that the batch or lot can be identified ISO &ANSI/AAMI ISO 15223-1:2012
Medical devices ñSymbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements
icon Use-by date 5.1.4
(ISO 7000 2607)
Indicates the date after which the medical device is not to be used ISO &ANSI/AAMI ISO 15223-1:2012
Medical devices ñSymbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements
icon Do not re-use 5.4.2
(ISO 7000 1051)
Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure ISO &ANSI/AAMI ISO 15223-1:2012
Medical devices ñSymbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements
icon 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 &ANSI/AAMI ISO 15223-1:2012
Medical devices ñSymbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements
icon Keep dry 5.3.4
(ISO 7000 0626)
Indicates a medical device that needs to be protected from moisture ISO &ANSI/AAMI ISO 15223-1:2012
Medical devices ñSymbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements
icon Keep away from sunlight 5.3.2
(ISO 7000 0624)
Indicates a medical device that needs protection from light sources ISO &ANSI/AAMI ISO 15223-1:2012
Medical devices ñSymbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements
icon Consult instructions for use 5.4.3
(ISO 7000 1641)
Indicate the need for the user to consult the instructions for use ISO &ANSI/AAMI ISO 15223-1:2012
Medical devices ñSymbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements
icon Sterilized using ethylene oxide 5.2.3
(ISO 7000 2501)
Indicated a medical device that has been sterilized using ethylene oxide ISO &ANSI/AAMI ISO 15223-1:2012
Medical devices ñSymbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements
icon Contains or presence of phthalates (DEHP) 4.2
(ISO 7000 2725)
Medical device contain Phtalates (DEHP) EN 15986:2011
icon Prescription use N/A Caution: Federal law restricts this device to sale by or order of a physician 21 CFR 801.109
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