BSCI Symbols Glossary

Orðalisti fyrir tákn

ISO 15223-1
	Framleiðandi
	Viðurkenndur fulltrúi í Evrópubandalaginu
	Viðurkenndur fulltrúi
	Viðurkenndur fulltrúi
	Viðurkenndur fulltrúi
	Viðurkenndur fulltrúi
	Viðurkenndur fulltrúi
	Framleiðsludagsetning
	Síðasti notkunardagur
	Lotunúmer
	Vörulistanúmer
	Innflytjandi
	Raðnúmer
	Tegundarnúmer
	Sæft
	Sæft með smitgátartækni
	Sæft með etýlenoxíði
	Sæft með geislun
	Sæft með gufu eða þurrum hita
	Endursæfið ekki
	Ekki Ósæft
	Notið ekki ef umbúðir eru skemmdar og kynnið ykkur notkunarleiðbeiningar
	Sæfð vökvaleið
	Sæfð vökvaleið
	Sæfð vökvaleið
	Kerfi með stökum smitsæfðum tálma
	Kerfi með tvöföldum smitsæfðum tálma
	Kerfi með stökum smitvarnartálma og innri hlífðarumbúðum
	Kerfi með stökum smitvarnartálma og ytri hlífðarumbúðum
	Brothætt, meðhöndlið með varúð
	Haldið fjarri sólarljósi
	Haldið þurru
	Neðri hitamörk
	Efri hitamörk
	Hitamörk
	Rakamörk
	Takmörkun loftþrýstings
	Líffræðileg áhætta
	Endurnotið ekki
	Lesið notkunarleiðbeiningar
	Lesið notkunarleiðbeiningar
	Varúð
	Inniheldur náttúrulegt gúmmílatex eða leifar þessgúmmílatexi
	Inniheldur afleiður úr blóði eða plasma úr mönnum
	Inniheldur lyf
	Inniheldur lífræn efni úr dýraríkinu
	Inniheldur lífræn efni úr mönnum
	Inniheldur hættuleg efni
	Margnota fyrir einn sjúkling
	Vökvaleið
	Veldur ekki sótthita
	Einstefnuloki
	Auðkenni sjúklings
	Heilsugæslustöð eða læknir
	Dagsetning
	Lækningatæki sem samræmist löggjöf Evrópusambandsins
	Þýðing
	Einkvæmt auðkenni tækis
ISO 7000/IEC 60417
	Endurvinnanlegt
IEC 60601-1
	Riðstraumur
	Jafnstraumur
	Jarðtenging (jörð)
	Jörð (jarðtenging)
	Spennujöfnun
	Búnaður í FLOKKI II
	„Kveikt“ (afl)
	„Slökkt“ (afl)
	„KVEIKT“/ „SLÖKKT“ (ýta-ýta)
	„Kveikt“ fyrir hluta búnaðar
	„Slökkt“ fyrir hluta búnaðar
	Hlutur af BF gerð
	Hlutur af CF gerð
	Búnaður í flokki AP
	Hættuleg spenna
	Hlutur með BF-vottun um að þola hjartarafstuð
	Hlutur með CF-vottun um að þola hjartarafstuð
	Biðstaða
	Almennt viðvörunarmerki
	Viðvörun, rafmagn
	Bannað að ýta
	Bannað að sitja
	Ekki stíga á yfirborðið
	Fylgið notkunarleiðbeiningum
	Fylgið notkunarleiðbeiningum
IEC 60601-1
	Varið gegn aðkomu fastra aðskotahluta sem eru 50 mm að þvermáli eða stærri
	Varið gegn aðkomu fastra aðskotahluta sem eru 12,5 mm að þvermáli eða stærri
	Varið gegn aðkomu fastra aðskotahluta sem eru 12,5 mm að þvermáli eða stærri Vernd gegn lóðrétt fallandi vatnsdropum
	Varið gegn aðkomu fastra aðskotahluta sem eru 2,5 mm að þvermáli eða stærri
	Óvarin
	Vernd gegn lóðrétt fallandi vatnsdropum
	Vörn gegn lóðrétt fallandi vatnsdropum þegar skilveggnum er hallað um allt að 15°
	Varin gegn vatnsskvettum
ISO 27185
	Hjartagangráður, eitt hólf, hægri slegill
	Hjartagangráður, eitt hólf, hægri gátt
	Hjartagangráður, tvö hólf, hægri gátt, hægri slegill
	Ígræðanlegt hjartastuðtæki, eitt hólf, hægri slegill
	Ígræðanlegt hjartastuðtæki, tvö hólf, hægri gátt, hægri slegill
	Endursamstillanlegur gangráður, hægri gátt, hægri slegill, vinstri slegill
	Endursamstillanlegt hjartastuðtæki, hægri gátt, hægri slegill, vinstri slegill
	Ígræðanlegt tæki
	Ígræðanlegt tæki (húðað)
	Framhlið
	Lykill, ígræðanlegur púlsgjafi
	Opnist hér
ASTM F 2503
	Þolir segulómun
	Þolir segulómun við ákveðin skilyrði
	Þolir ekki segulómun
IEC TR 60878
	Innra þvermál
	Ytra þvermál

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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