SYMBOL GLOSSARY

 
ISO 15223-1
Manufacturer
Fabricante
Authorized representative in the European Community
Representante autorizado na Comunidade Europeia
Date of Manufacture Data de fabricação
Use-by date Usar até
Lot Number Número do lote
Catalog Number Número de catálogo
Serial Number Número serial
Manufacturer
Esterilizado
Manufacturer
Esterilizado por técnicas de processamento assépticas
Manufacturer
Esterilizado com óxido de etileno
Manufacturer
Esterilizado por irradiação
Manufacturer
Esterilizado a vapor (ou a seco)
Manufacturer
Não reesterilizar
Manufacturer
Não estéril
Manufacturer
Não utilize se a embalagem estiver danificada e consulte as instruções de uso
Manufacturer
Via de fluido esterilizado
Manufacturer
Via de fluido esterilizado
Manufacturer
Via de fluido esterilizado
Manufacturer
Sistema de barreira estéril simples
Manufacturer
Sistema de barreira estéril dupla
Manufacturer
Sistema de barreira estéril simples com embalagem protetora interna
glossary icon
Sistema de barreira estéril simples com embalagem protetora externa
glossary icon
Frágil, manuseie com cuidado
glossary icon
Mantenha distante da luz solar
glossary icon
Mantenha seco
glossary icon
Limite inferior de temperatura
glossary icon
Limite superior de temperatura
glossary icon
Limite de temperatura
glossary icon
Limitação de umidade
glossary icon
Limite de pressão atmosférica
glossary icon
Riscos biológicos
glossary icon
Não reutilizar
glossary icon
Consulte as instruções de uso.
glossary icon
Consulte as instruções de uso.
glossary icon
CUIDADO
glossary icon

Contém ou indica presença de látex de borracha natural
glossary icon
Contém derivados de sangue ou plasma humano
glossary icon
Contém uma substância médica
glossary icon
Contém material biológico de origem animal
glossary icon
Contém material biológico de origem humana
glossary icon
Contém substâncias perigosas
glossary icon
Uso múltiplo para um nico paciente
glossary icon
Via do fluido
glossary icon
Apirogênico
glossary icon
Válvula de via única
glossary icon
Identificação do paciente
glossary icon
Posto de saúde ou médico
glossary icon
Data
glossary icon
Dispositivo médico
glossary icon
Tradução
glossary icon
Identificador exclusivo de dispositivo
ISO 7000/IEC 60417
glossary icon
Reciclável
IEC 60601-1
glossary icon
Corrente alternada
glossary icon
Condutor de proteção (terra)
glossary icon
Terra (aterramento)
glossary icon
Equipotencialidade
glossary icon
Equipamento Classe II
glossary icon
"LIGADO" (alimentação)
glossary icon
"DESLIGADO" (alimentação)
glossary icon
"LIGADO" para parte do equipamento
glossary icon
"DESLIGADO" para parte do equipamento
glossary icon
Peça aplicada tipo BF
glossary icon
Peça aplicada tipo CF
glossary icon
Equipamento de categoria AP
glossary icon
Tensão perigosa
glossary icon
Peça aplicada tipo BF à prova de desfibrilação
glossary icon
Peça aplicada tipo CF à prova de desfibrilação
glossary icon
Em espera
glossary icon
Sinal geral de advertência
glossary icon
Proibido empurrar
glossary icon
Proibido sentar
glossary icon
Proibido pisar
glossary icon
Siga as Instruções de Uso
glossary icon
Siga as Instruções de Uso
IEC 60601-1
glossary icon
Protegido contra objetos sólidos estranhos com diâmetro de 50 mm e superior
glossary icon
Protegido contra objetos sólidos estranhos com diâmetro de 12,5 mm e superior
glossary icon
Protegido contra objetos sólidos estranhos com diâmetro de 12,5 mm e superior
Proteção contra queda vertical de gotas de água
glossary icon
Protegido contra objetos sólidos estranhos com diâmetro de 2,5 mm e superior
glossary icon
Não protegido
glossary icon
Proteção contra queda vertical de gotas de água
glossary icon
Proteção contra a queda vertical de gotas de água com o recipiente inclinado em até 15°
glossary icon
Protegido contra respingos de água
ASTM F 2503
glossary icon
Uso seguro em ambiente de RM
glossary icona
Uso condicional para ambiente de RM
glossary icon
Uso não seguro em ambiente de RM
Symbol Title Reference Description
ISO 15223-1: 5.1. Manufacture
Manufacturer
Manufacturer 5.1.1. Indicates the medical device manufacturer
Authorized representative in the European Community
Authorized representative in the European Community 5.1.2. Indicates the authorized representative in the European Community / European Union.
Date of Manufacture Date of manufacture 5.1.3. Indicates the date when the medical device was manufactured.
Use-by date Use-by date 5.1.4. Indicates the date after which the medical device is not to be used.
Lot Number Lot number 5.1.5. Indicates the manufacturer’s batch code so that the batch or lot can be identified.
Catalog Number Catalog number 5.1.6. Indicates the manufacturer’s catalogue number so that the medical device can be identified.
Serial Number Serial number 5.1.7. Indicates the manufacturer’s serial number so that a specific medical device can be identified.
ISO 15223-1: 5.2. Sterility
Manufacturer
Sterile 5.2.1. Indicates a medical device that has been subjected to a sterilization process.
Manufacturer
Sterilized using ethylene oxide 5.2.3. Indicates a medical device that has been sterilized using ethylene oxide.
Manufacturer
Sterilized using irradiation 5.2.4. Indicates a medical device that has been sterilized using irradiation.
Manufacturer
Sterilized using steam or dry heat 5.2.5. Indicates a medical device that has been sterilized using steam or dry heat.
Manufacturer
Do Not Resterilize 5.2.6. Indicates a medical device that is not to be resterilized.
Manufacturer
Non-Sterile 5.2.7. Indicates a medical device that has not been subjected to a sterilization process.
Manufacturer
Do not use if package is damaged and consult instructions for use 5.2.8. Indicates a medical device that should not be used if the package has been damaged or opened.
Manufacturer
Sterile fluid path 5.2.9. Indicates the presence of a sterile fluid path within the medical device in cases when other parts of the medical device, including the exterior, might not be supplied sterile.
Manufacturer
Sterile fluid path 5.2.9.
A.12, NOTE 1
A.12 Examples of use of symbol 5.2.9 for “Sterile fluid path”
NOTE 1: Medical device contains a sterile fluid path that has been sterilized using ethylene oxide
Manufacturer
Sterile fluid path 5.2.9.
A.12, NOTE 2
A.12 Examples of use of symbol 5.2.9 for “Sterile fluid path”
NOTE 2: Medical device contains a sterile fluid path that has been sterilized using irradiation.
Manufacturer
Single sterile barrier system 5.2.11. Indicates a single sterile barrier system.
Manufacturer
Double sterile barrier system 5.2.12. Indicates two sterile barrier systems.
Manufacturer
Single sterile barrier system with protective packaging inside 5.2.13. Indicates a single sterile barrier system with protective packaging inside
glossary icon
Single sterile barrier system with protective packaging outside 5.2.14. Indicates a single sterile barrier system with protective packaging outside
ISO 15223-1: 5.3. Storage
glossary icon
Fragile, handle with care 5.3.1. Indicates a medical device that can be broken or damaged if not handled carefully.
glossary icon
Keep away from sunlight 5.3.2. Indicates a medical device that needs protection from light sources.
glossary icon
Keep dry 5.3.4. Indicates a medical device that needs to be protected from moisture.
glossary icon
Lower limit of temperature 5.3.5. Indicates the lower limit of temperature to which the medical device can be safely exposed.
glossary icon
Upper limit of temperature 5.3.6. Indicates the upper limit of temperature to which the medical device can be safely exposed.
glossary icon
Temperature limit 5.3.7. Indicates the temperature limits to which the medical device can be safely exposed.
glossary icon
Humidity limitation 5.3.8. Indicates the range of humidity to which the medical device can be safely exposed.
glossary icon
Atmospheric pressure limitation 5.3.9. Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
ISO 15223-1: 5.4. Safe use
glossary icon
Biological risks 5.4.1. Indicates that there are potential biological risks associated with the medical device.
glossary icon
Do not re-use 5.4.2. Indicates a medical device that is intended for one single use only.
glossary icon
Consult instructions for use 5.4.3. Indicates the need for the user to consult the instructions for use.
glossary icon
Consult instructions for use 5.4.3. A.16 NOTE A.16 Example of use of symbol 5.4.3, “Consult instructions for use” for an electronic instruction for use (eIFU)
NOTE: The eIFU indicator can be a manufacturer’s website URL or some other appropriate indication that the instructions for use are available in an electronic format.
glossary icon
Caution 5.4.4. To indicate that caution is necessary when operating the device or control close to where the symbol is placed, or to indicate that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.
glossary icon
Contains or presence of natural rubber latex 5.4.5. Indicates the presence of dry natural rubber or natural rubber latex as a material of construction within the medical device or the packaging of a medical device.
glossary icon
Contains human blood or plasma derivatives 5.4.6. Indicates a medical device that contains or incorporates human blood or plasma derivatives.
glossary icon
Contains a medicinal substance 5.4.7. Indicates a medical device that contains or incorporates a medicinal substance
glossary icon
Contains biological material of animal origin 5.4.8. Indicates a medical device that contains biological tissue, cells, or their derivatives, of animal origin
glossary icon
Contains biological material of human origin 5.4.9. Indicates a medical device that contains biological tissue, cells, or their derivatives, of human origin
glossary icon
Contains hazardous substances 5.4.10. Indicates a medical device that contains substances that can be carcinogenic, mutagenic, reprotoxic (CMR), or substances with endocrine disrupting properties
glossary icon
Single patient multiple use 5.4.12. Indicates a medical device that may be used multiple times (multiple procedures) on a single patient
ISO 15223-1: 5.6. Transfusion/infusion
glossary icon
Fluid path 5.6.2. Indicates the presence of a fluid path.
glossary icon
Non-pyrogenic 5.6.3. Indicates a medical device that is non-pyrogenic.
glossary icon
One-way valve 5.6.6. Indicates a medical device with a valve that allows flow in only one direction.
ISO 15223-1: 5.7. Others
glossary icon
Patient identification 5.7.3. Indicates the identification data of the patient
glossary icon
Health care centre or doctor 5.7.5. To indicate the address of the health care centre or doctor where medical information about the patient may be found
glossary icon
Date 5.7.6. To identify the date that information was entered or a medical procedure took place
glossary icon
Medical device 5.7.7. Indicates the item is a medical device (under EU Legislation)
glossary icon
Translation 5.7.8. To identify that the original medical device information has undergone a translation which supplements or replaces the original information
glossary icon
Unique Device Identifier 5.7.10. Indicates a carrier that contains Unique Device Identifier information
ISO 7000/IEC 60417
glossary icon
Recyclable 7000 - 1135 To indicate that the marked item or its material is part of a recovery or recycling process.
IEC 60601-1: General Symbols
glossary icon
Alternating current Table D1, Symbol 1 To indicate on the rating plate that the equipment is suitable for alternating currentonly; to identify relevant terminals.
glossary icon
Direct current Table D.1, Symbol 4 To indicate on the rating plate that the equipment is suitable for direct currentonly; to identify relevant terminals.
glossary icon
Protective earth (ground) Table D.1, Symbol 6 To identify any terminal which is intended for connection to an external conductorfor protection against electric shock in case of a fault, or the terminal of a protectiveearth (ground) electrode.
glossary icon
Earth (ground) Table D.1, Symbol 7 To identify an earth (ground) terminal in cases where neither the symbol 5018 nor 5019 is explicitly required.
glossary icon
Equipotentiality Table D.1, Symbol 8 To identify the terminals which, when connected together, bring the various parts of an equipment or of a system to the same potential, not necessarily being the earth (ground) potential, e.g. for local bonding.
glossary icon
CLASS II equipment Table D.1, Symbol 9 To identify equipment meeting the safety requirements specified for Class II equipment according to IEC 61140.
glossary icon
“ON” (power) Table D.1, Symbol 12 To indicate connection to the mains, at least for mains switches or their positions, and all those cases where safety is involved.
glossary icon
“OFF” (power) Table D.1, Symbol 13 To indicate disconnection from the mains, at least for mains switches or their positions, and all those cases where safety is involved.
glossary icon
“ON” for part of equipment Table D.1, Symbol 16 To indicate the ""ON"" condition for a part of equipment, if the symbol 5007 cannot be used, for example, to identify the ""ON"" position of a switch.
glossary icon
“OFF” for part of equipment Table D.1, Symbol 17 To indicate the ""OFF"" condition for a part of equipment, if the symbol 5008 cannot be used, for example, to identify the ""OFF"" position of a switch.
glossary icon
Type BF applied part Table D.1, Symbol 20 To identify a type BF applied part complying with IEC 60601-1.
glossary icon
Type CF applied part Table D.1, Symbol 21 To identify a type CF applied part complying with IEC 60601-1.
glossary icon
CATEGORY AP equipment Table D.1, Symbol 22 To identify category AP equipment complying with IEC 60601-1 which also specifies the way in which this symbol has to be used.
glossary icon
Dangerous voltage Table D.1, Symbol 24 To indicate hazards arising from dangerous voltages.
glossary icon
Defibrillation-proof type BF applied part Table D.1, Symbol 26 To identify a defibrillation-proof type BF applied part complying with IEC 60601-1.
glossary icon
Defibrillation-proof type CF applied part Table D.1, Symbol 27 To identify a defibrillation-proof type CF applied part complying with IEC 60601-1.
glossary icon
Stand-by Table D.1, Symbol 29 To identify the switch or switch position by means of which part of the equipment is switched on in order to bring it into the stand-by condition, and to identify the control to shift to or to indicate the state of low power consumption.
glossary icon
General warning sign Table D.2, Symbol 2 To signify a general warning
glossary icon
Warning, electricity Table D.2, Symbol 3 To warn of electricity
glossary icon
No pushing Table D.2, Symbol 5 To prohibit pushing against an object
glossary icon
No sitting Table D.2, Symbol 6 To prohibit sitting on a surface
glossary icon
No stepping on surface Table D.2, Symbol 7 To prohibit stepping onto a surface
glossary icon
Follow instructions for use Table D.2, Symbol 10 Symbol must appear in color. Limited to Medical Electrical Equipment covered by EN 60601-1
glossary icon
Follow instructions for use ISO 15223-1: 5.4.3. A.16 NOTE NOTE: The eIFU indicator can be a manufacturer’s website URL or some other appropriate indication that the instructions for use are available in an electronic format.
IEC 60601-1;
glossary icon
  Table D.3, Symbol 2 Degrees of protection provided by enclosures
N1 =
0 Non-protected
1 Protected against solid foreign objects of 50 mm and greater
2 Protected against solid foreign objects of 12,5 mm and greater
3 Protected against solid foreign objects of 2,5 mm and greater
4 Protected against solid foreign objects of 1,0 mm and greater
5 Dust-protected
6 Dust-tight
N2 =
0 Non-protected
1 Protection against vertically falling water drops
2 Protection against vertically falling water drops when ENCLOSURE tilted up to 15°
3 Protected against spraying water
4 Protected against splashing water
5 Protected against water jets
6 Protected against powerful water jets
7 Protected against the effects of temporary immersion in water
8 Protected against the effects of continuous immersion in water
NOTE When a characteristic numeral is not required to be specified, it is replaced by the letter “X” (“XX” if both numerals are omitted).
glossary icon
Protected against solid foreign objects of 12,5 mm and greater
glossary icon
Protected against solid foreign objects of 12,5 mm and greater Protection against vertically falling water drops
glossary icon
Protected against solid foreign objects of 2,5 mm and greater
glossary icon
Non-protected
glossary icon
Protection against vertically falling water drops
glossary icon
Protection against vertically falling water drops when ENCLOSURE tilted up to 15°
glossary icon
Protected against splashing water
ASTM F 2503; Magnetic Resonance
glossary icon
MR Safe ASTM F2503-20: 7.3.1 An item that poses no known hazards resulting from exposure to any MR environment. MR Safe items are composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic.(ASTM F2503-20:3.1.13)
glossary icon
MR Conditional ASTM F2503-20: 7.3.2 An item with demonstrated safety in the MR environment within defined conditions including conditions for the static magnetic field, the time-varying gradient magnetic fields and the radiofrequency fields. (ASTM F2503-20:3.1.11)
glossary icon
MR Unsafe ASTM F2503-20: 7.3.3 An item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. (ASTM F2503-20:3.1.14)
Top