El contenido de esta página está restringido sólo para profesionales de la salud debido a la obligación exigida por Ministerio de Sanidad en el Real Decreto 9/1996 de 15 de enero, y en cumplimiento del mismo.

¿Eres un profesional?

Glosario

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 Symbols 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 Symbols 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 Symbols 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 Symbols 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 Symbols 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 Symbols 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 Symbols 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 Symbols 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 Symbols 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 Symbols 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