BSCI Symbols Glossary

Opisy symboli

ISO 15223-1
	Wytwórca
	Upoważniony przedstawiciel w Unii Europejskiej
	Autoryzowany przedstawiciel
	Autoryzowany przedstawiciel
	Autoryzowany przedstawiciel
	Autoryzowany przedstawiciel
	Autoryzowany przedstawiciel
	Data produkcji
	Data ważności
	Numer serii
	Numer katalogowy
	Importer
	Numer seryjny
	Numer modelu
	Jałowa
	Wysterylizowano za pomocą metod aseptycznych
	Sterylizowano przy użyciu tlenku etylenu
	Sterylizacja przez napromienianie
	Wysterylizowano parą lub suchym gorącym powietrzem
	Nie resterylizować
	Niejałowy
	Nie używać, jeśli opakowanie jest uszkodzone, i zapoznać się z instrukcją obsługi
	Ścieżka płynu jałowego
	Ścieżka płynu jałowego
	Ścieżka płynu jałowego
	System pojedynczej jałowej bariery
	System podwójnej jałowej bariery
	System pojedynczej jałowej bariery z opakowaniem ochronnym wewnątrz
	System pojedynczej jałowej bariery z opakowaniem ochronnym na zewnątrz
	Produkt delikatny, obchodzić się ostrożnie
	Chronić przed światłem słonecznym
	Przechowywać w suchym miejscu
	Najniższa dopuszczalna temperatura
	Najwyższa dopuszczalna temperatura
	Granice temperatury
	Graniczne wartości wilgotności
	Graniczne wartości ciśnienia atmosferycznego
	Zagrożenia biologiczne
	Nie używać powtórnie
	Zapoznać się ze sposobem użycia
	Zapoznać się ze sposobem użycia
	Ostrzeżenie
	Produkt lub opakowanie zawiera lateks naturalny
	Zawiera pochodne krwi ludzkiej lub osocza ludzkiego
	Zawiera substancję leczniczą
	Zawiera materiał biologiczny pochodzenia zwierzęcego
	Zawiera materiał biologiczny pochodzenia ludzkiego
	Zawiera substancje niebezpieczne
	Do wielokrotnego uzytku u jednego pacjenta
	Ścieżka płynu
	Niepirogenne
	Zastawka jednokierunkowa
	Identyfikacja pacjenta
	Placówka ochrony zdrowia lub lekarz
	Data
	Wyrób medyczny w świetle przepisów UE
	Tłumaczenie
	Unikatowy identyfikator urządzenia
ISO 7000/IEC 60417
	Produkt nadaje się do recyklingu
IEC 60601-1
	Prąd przemienny
	Prąd stały
	Uziemienie ochronne
	Uziemienie
	Ekwipotencjalność
	Wyposażenie KLASY II
	„WŁ.” (zasilanie)
	„WYŁ.” (zasilanie)
	„WŁ.” / „WYŁ.” (typu push-push)
	„WŁ.” dla części urządzenia
	„WYŁ.” dla części urządzenia
	Zastosowana część typu BF
	Zastosowana część typu CF
	Sprzęt kategorii AP
	Niebezpieczne napięcie
	Część aplikacyjna typu BF odporna na defibrylację
	Część aplikacyjna typu CF odporna na defibrylację
	Tryb czuwania
	Znak przestrogi ogólnej
	Przestroga — prąd
	Nie pchać
	Nie siadać
	Nie stawać na powierzchni
	Postępować zgodnie z instrukcją obsługi
	Postępować zgodnie z instrukcją obsługi
IEC 60601-1
	Ochrona przed wnikaniem obcych ciał stałych o średnicy 50 mm i większej
	Ochrona przed wnikaniem obcych ciał stałych o średnicy 12,5 mm i większej
	Ochrona przed wnikaniem obcych ciał stałych o średnicy 12,5 mm i większej Ochrona przed kroplami wody padającymi pionowo
	Ochrona przed wnikaniem obcych ciał stałych o średnicy 2,5 mm i większej
	Niechroniony
	Ochrona przed kroplami wody padającymi pionowo
	Ochrona przed kroplami wody padającymi pionowo, gdy kąt nachylenia obudowy nie przekracza 15°
	Ochrona przed rozpryskami wody
ISO 27185
	Stymulator, jednojamowy, prawokomorowy
	Stymulator, jednojamowy, prawoprzedsionkowy
	Stymulator, dwujamowy, prawoprzedsionkowy, prawokomorowy
	Wszczepialny kardiowerter-defibrylator, jednojamowy, prawokomorowy
	Wszczepialny kardiowerter-defibrylator, dwujamowy, prawoprzedsionkowy, prawokomorowy
	Stymulator resynchronizujący, prawoprzedsionkowy, prawokomorowy, lewokomorowy
	Defibrylator stymulujący resynchronizację serca, prawoprzedsionkowy, prawokomorowy, lewokomorowy
	Urządzenie wszczepialne
	Urządzenie wszczepialne (powlekane)
	Powierzchnia czołowa
	Klucz dynamometryczny, wszczepialny generator impulsów
	Tu otwierać
ASTM F 2503
	MR – produkt bezpieczny
	MR – produkt warunkowo bezpieczny
	MR – produkt niebezpieczny
IEC TR 60878
	Średnica wewnętrzna
	Średnica zewnętrzna

Symbol	Title	Reference	Description
ISO 15223-1: 5.1. Manufacture
	Manufacturer	5.1.1.	Indicates the medical device manufacturer
	Authorized representative in the European Community	5.1.2.	Indicates the authorized representative in the European Community / European Union.
	Date of manufacture	5.1.3.	Indicates the date when the medical device was manufactured.
	Use-by date	5.1.4.	Indicates the date after which the medical device is not to be used.
	Lot number	5.1.5.	Indicates the manufacturer’s batch code so that the batch or lot can be identified.
	Catalog number	5.1.6.	Indicates the manufacturer’s catalogue number so that the medical device can be identified.
	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
	Sterile	5.2.1.	Indicates a medical device that has been subjected to a sterilization process.
	Sterilized using ethylene oxide	5.2.3.	Indicates a medical device that has been sterilized using ethylene oxide.
	Sterilized using irradiation	5.2.4.	Indicates a medical device that has been sterilized using irradiation.
	Sterilized using steam or dry heat	5.2.5.	Indicates a medical device that has been sterilized using steam or dry heat.
	Do Not Resterilize	5.2.6.	Indicates a medical device that is not to be resterilized.
	Non-Sterile	5.2.7.	Indicates a medical device that has not been subjected to a sterilization process.
	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.
	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.
	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
	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.
	Single sterile barrier system	5.2.11.	Indicates a single sterile barrier system.
	Double sterile barrier system	5.2.12.	Indicates two sterile barrier systems.
	Single sterile barrier system with protective packaging inside	5.2.13.	Indicates a single sterile barrier system with protective packaging inside
	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
	Fragile, handle with care	5.3.1.	Indicates a medical device that can be broken or damaged if not handled carefully.
	Keep away from sunlight	5.3.2.	Indicates a medical device that needs protection from light sources.
	Keep dry	5.3.4.	Indicates a medical device that needs to be protected from moisture.
	Lower limit of temperature	5.3.5.	Indicates the lower limit of temperature to which the medical device can be safely exposed.
	Upper limit of temperature	5.3.6.	Indicates the upper limit of temperature to which the medical device can be safely exposed.
	Temperature limit	5.3.7.	Indicates the temperature limits to which the medical device can be safely exposed.
	Humidity limitation	5.3.8.	Indicates the range of humidity to which the medical device can be safely exposed.
	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
	Biological risks	5.4.1.	Indicates that there are potential biological risks associated with the medical device.
	Do not re-use	5.4.2.	Indicates a medical device that is intended for one single use only.
	Consult instructions for use	5.4.3.	Indicates the need for the user to consult the instructions for use.
	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.
	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.
	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.
	Contains human blood or plasma derivatives	5.4.6.	Indicates a medical device that contains or incorporates human blood or plasma derivatives.
	Contains a medicinal substance	5.4.7.	Indicates a medical device that contains or incorporates a medicinal substance
	Contains biological material of animal origin	5.4.8.	Indicates a medical device that contains biological tissue, cells, or their derivatives, of animal origin
	Contains biological material of human origin	5.4.9.	Indicates a medical device that contains biological tissue, cells, or their derivatives, of human origin
	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
	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
	Fluid path	5.6.2.	Indicates the presence of a fluid path.
	Non-pyrogenic	5.6.3.	Indicates a medical device that is non-pyrogenic.
	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
	Patient identification	5.7.3.	Indicates the identification data of the patient
	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
	Date	5.7.6.	To identify the date that information was entered or a medical procedure took place
	Medical device	5.7.7.	Indicates the item is a medical device (under EU Legislation)
	Translation	5.7.8.	To identify that the original medical device information has undergone a translation which supplements or replaces the original information
	Unique Device Identifier	5.7.10.	Indicates a carrier that contains Unique Device Identifier information
ISO 7000/IEC 60417
	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
	Alternating current	Table D1, Symbol 1	To indicate on the rating plate that the equipment is suitable for alternating currentonly; to identify relevant terminals.
	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.
	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.
	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.
	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.
	CLASS II equipment	Table D.1, Symbol 9	To identify equipment meeting the safety requirements specified for Class II equipment according to IEC 61140.
	“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.
	“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.
	“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.
	“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.
	Type BF applied part	Table D.1, Symbol 20	To identify a type BF applied part complying with IEC 60601-1.
	Type CF applied part	Table D.1, Symbol 21	To identify a type CF applied part complying with IEC 60601-1.
	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.
	Dangerous voltage	Table D.1, Symbol 24	To indicate hazards arising from dangerous voltages.
	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.
	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.
	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.
	General warning sign	Table D.2, Symbol 2	To signify a general warning
	Warning, electricity	Table D.2, Symbol 3	To warn of electricity
	No pushing	Table D.2, Symbol 5	To prohibit pushing against an object
	No sitting	Table D.2, Symbol 6	To prohibit sitting on a surface
	No stepping on surface	Table D.2, Symbol 7	To prohibit stepping onto a surface
	Follow instructions for use	Table D.2, Symbol 10	Symbol must appear in color. Limited to Medical Electrical Equipment covered by EN 60601-1
	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;
		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).
	Protected against solid foreign objects of 12,5 mm and greater
	Protected against solid foreign objects of 12,5 mm and greater Protection against vertically falling water drops
	Protected against solid foreign objects of 2,5 mm and greater
	Non-protected
	Protection against vertically falling water drops
	Protection against vertically falling water drops when ENCLOSURE tilted up to 15°
	Protected against splashing water
ASTM F 2503; Magnetic Resonance
	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)
	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)
	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)

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