BSCI Symbols Glossary

SYMBOLS GLOSSARY

Symbol	Title	Reference	Description
ISO 15223-1: 5.1. Manufacture
	Manufacturer	5.1.1.	Indicates the medical device manufacturer.
	Authorized representative	5.1.2.	Indicates the authorized representative in the identified jurisdiction.
	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. NOTE: Synonyms for “use-by date” are “use by”, “expiry date” and “expiration date”.
	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. NOTE: Synonyms for “catalog number” are “commercial product name”, “commercial product code”, stock keeping unit, “reference number” and “reorder number”.
	Serial number	5.1.7.	Indicates the manufacturer’s serial number so that a specific medical device can be identified.
	Importer	5.1.8.	Indicates the entity importing the medical device into the locale.
	Model number	5.1.10.	Indicates the model number or type number of a product
ISO 15223-1: 5.2. Sterility
	Sterile	5.2.1.	Indicates a medical device that has been subjected to a sterilization process.
	Sterilized using aseptic processing techniques	5.2.2.	Indicates a medical device that has been manufactured using accepted aseptic techniques.
	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. NOTE 1: This symbol can also mean “Do not use if the product sterile barrier system or its packaging is compromised”.
	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. NOTE: This symbol can also mean “Keep away from heat”.
	Protect from heat and radioactive sources	5.3.3.	Indicates a medical device that needs protection from heat and radioactive 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.
	Contains nano materials	5.4.11.	Indicates a medical device that contains nano materials.
	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.
	Patient information website	5.7.4.	Indicates a website where a patient can obtain additional information on the medical product. NOTE Usage is to indicate location of information available to 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.
IEC 60601-1: General Symbols
	Alternating current	Table D1, Symbol 1	To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals.
	Direct current	Table D1, Symbol 4	To indicate on the rating plate that the equipment is suitable for direct current only; to identify relevant terminals.
	Protective earth (ground)	Table D.1, Symbol 6	To identify any terminal which is intended for connection to an external conductor for protection against electric shock in case of a fault, or the terminal of a protective earth (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” / “OFF” (push-push)	Table D.1, Symbol 14	To indicate connection to or disconnection from the mains, at least for mains switches or their positions, and all those cases where safety is involved. Each position, "ON" or "OFF", is a stable position.
	“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;
	Degrees of protection provided by enclosures.	Table D.3, Symbol 2	NOTE When a characteristic numeral is not required to be specified, it is replaced by the letter “X” (“XX” if both numerals are omitted).
N1=0	Non-protected
N1=1	Protected against solid foreign objects of 50 mm diameter and greater
N1=2	Protected against solid foreign objects of 12.5 mm diameter and greater
N1=3	Protected against solid foreign objects of 2.5 mm diameter and greater
N1=4	Protected against solid foreign objects of 1.0 mm diameter and greater
N1=5	Dust-protected
N1=6	Dust-tight
N2=0	Non-protected
N2=1	Protection against vertically falling water drops
N2=2	Protection against vertically falling water drops when enclosure tilted up to 15°
N2=3	Protected against spraying water
N2=4	Protected against splashing water
N2=5	Protected against water jets
N2=7	Protected against the effects of temporary immersion in water
N2=8	Protected against the effects of continuous immersion in water
ISO 27185; Symbols
	Pacemaker, single chamber, right ventricular	6.1	To indicate an implantable pacemaker that is intended to stimulate and sense in the right ventricle of the heart.
	Pacemaker, single chamber, right atrial	6.2	To indicate an implantable pacemaker that is intended to stimulate and sense in the right atrium of the heart.
	Pacemaker, dual chamber, right atrial, right ventricular	6.3	To indicate an implantable pacemaker that is intended to stimulate and sense in both the right atrium and right ventricle of the heart.
	Implantable cardioverter defibrillator, single chamber, right ventricular	6.4	To indicate an implantable cardioverter defibrillator that is intended to stimulate and sense in the right ventricle and to shock the heart.
	Implantable cardioverter defibrillator, dual chamber, right atrial, right ventricular	6.5	To indicate an implantable cardioverter defibrillator that is intended to stimulate and sense in the right atrium and right ventricle and to shock the heart.
	Cardiac resynchronization therapy pacemaker, right atrial, right ventricular, left ventricular	6.6	To indicate an implantable pacemaker that is intended to stimulate and sense in the right atrium, right ventricle and left ventricle of the heart.
	Cardiac resynchronization therapy defibrillator, right atrial, right ventricular, left ventricular	6.7	To indicate an implantable cardioverter defibrillator that is intended to stimulate and sense in the right atrium, right ventricle and left ventricle; and to shock the heart.
	Implantable device	6.8	To indicate an implantable device.
	Implantable device (coated)	6.9	To indicate an implantable device with coating for allergies or to prevent unintended muscle stimulation.
	Header face	6.25	To indicate the header face to be used for identifying connector bore locations.
	Torque wrench, implantable pulse generator	6.40	Torque-limiting wrench used to connect a lead to an implantable pulse generator.
	Open here	6.42	To indicate the location and method for opening a sterile package.
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)
IEC TR 60878; 5.5 Collection 5 – General: Miscellaneous
	Inner diameter	5845	To indicate a reference to the inner diameter.
	Outer diameter	5846	To indicate a reference to the outer diameter.
IEC TR 60878; 5.5 Collection 6 – Transport, handling and packaging
	Recyclable	7000 - 1135	To indicate that the marked item or its material is part of a recovery or recycling process.

Symbol	Title	Reference	Description
ISO 15223-1: 5.1. Manufacture
	Manufacturer	5.1.1.	Indicates the medical device manufacturer.
	Authorized representative	5.1.2.	Indicates the authorized representative in the identified jurisdiction.
	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. NOTE: Synonyms for “use-by date” are “use by”, “expiry date” and “expiration date”.
	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. NOTE: Synonyms for “catalog number” are “commercial product name”, “commercial product code”, stock keeping unit, “reference number” and “reorder number”.
	Serial number	5.1.7.	Indicates the manufacturer’s serial number so that a specific medical device can be identified.
	Importer	5.1.8.	Indicates the entity importing the medical device into the locale.
	Model number	5.1.10.	Indicates the model number or type number of a product
ISO 15223-1: 5.2. Sterility
	Sterile	5.2.1.	Indicates a medical device that has been subjected to a sterilization process.
	Sterilized using aseptic processing techniques	5.2.2.	Indicates a medical device that has been manufactured using accepted aseptic techniques.
	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. NOTE 1: This symbol can also mean “Do not use if the product sterile barrier system or its packaging is compromised”.
	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. NOTE: This symbol can also mean “Keep away from heat”.
	Protect from heat and radioactive sources	5.3.3.	Indicates a medical device that needs protection from heat and radioactive 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.
	Contains nano materials	5.4.11.	Indicates a medical device that contains nano materials.
	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.
	Patient information website	5.7.4.	Indicates a website where a patient can obtain additional information on the medical product. NOTE Usage is to indicate location of information available to 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.
IEC 60601-1: General Symbols
	Alternating current	Table D1, Symbol 1	To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals.
	Direct current	Table D1, Symbol 4	To indicate on the rating plate that the equipment is suitable for direct current only; to identify relevant terminals.
	Protective earth (ground)	Table D.1, Symbol 6	To identify any terminal which is intended for connection to an external conductor for protection against electric shock in case of a fault, or the terminal of a protective earth (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” / “OFF” (push-push)	Table D.1, Symbol 14	To indicate connection to or disconnection from the mains, at least for mains switches or their positions, and all those cases where safety is involved. Each position, "ON" or "OFF", is a stable position.
	“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;
	Degrees of protection provided by enclosures.	Table D.3, Symbol 2	NOTE When a characteristic numeral is not required to be specified, it is replaced by the letter “X” (“XX” if both numerals are omitted).
N1=0	Non-protected
N1=1	Protected against solid foreign objects of 50 mm diameter and greater
N1=2	Protected against solid foreign objects of 12.5 mm diameter and greater
N1=3	Protected against solid foreign objects of 2.5 mm diameter and greater
N1=4	Protected against solid foreign objects of 1.0 mm diameter and greater
N1=5	Dust-protected
N1=6	Dust-tight
N2=0	Non-protected
N2=1	Protection against vertically falling water drops
N2=2	Protection against vertically falling water drops when enclosure tilted up to 15°
N2=3	Protected against spraying water
N2=4	Protected against splashing water
N2=5	Protected against water jets
N2=7	Protected against the effects of temporary immersion in water
N2=8	Protected against the effects of continuous immersion in water
ISO 27185; Symbols
	Pacemaker, single chamber, right ventricular	6.1	To indicate an implantable pacemaker that is intended to stimulate and sense in the right ventricle of the heart.
	Pacemaker, single chamber, right atrial	6.2	To indicate an implantable pacemaker that is intended to stimulate and sense in the right atrium of the heart.
	Pacemaker, dual chamber, right atrial, right ventricular	6.3	To indicate an implantable pacemaker that is intended to stimulate and sense in both the right atrium and right ventricle of the heart.
	Implantable cardioverter defibrillator, single chamber, right ventricular	6.4	To indicate an implantable cardioverter defibrillator that is intended to stimulate and sense in the right ventricle and to shock the heart.
	Implantable cardioverter defibrillator, dual chamber, right atrial, right ventricular	6.5	To indicate an implantable cardioverter defibrillator that is intended to stimulate and sense in the right atrium and right ventricle and to shock the heart.
	Cardiac resynchronization therapy pacemaker, right atrial, right ventricular, left ventricular	6.6	To indicate an implantable pacemaker that is intended to stimulate and sense in the right atrium, right ventricle and left ventricle of the heart.
	Cardiac resynchronization therapy defibrillator, right atrial, right ventricular, left ventricular	6.7	To indicate an implantable cardioverter defibrillator that is intended to stimulate and sense in the right atrium, right ventricle and left ventricle; and to shock the heart.
	Implantable device	6.8	To indicate an implantable device.
	Implantable device (coated)	6.9	To indicate an implantable device with coating for allergies or to prevent unintended muscle stimulation.
	Header face	6.25	To indicate the header face to be used for identifying connector bore locations.
	Torque wrench, implantable pulse generator	6.40	Torque-limiting wrench used to connect a lead to an implantable pulse generator.
	Open here	6.42	To indicate the location and method for opening a sterile package.
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)
IEC TR 60878; 5.5 Collection 5 – General: Miscellaneous
	Inner diameter	5845	To indicate a reference to the inner diameter.
	Outer diameter	5846	To indicate a reference to the outer diameter.
IEC TR 60878; 5.5 Collection 6 – Transport, handling and packaging
	Recyclable	7000 - 1135	To indicate that the marked item or its material is part of a recovery or recycling process.

^{Applicable Standards

ISO 15223-1, Medical Devices – Symbols to be used with medical device labels, labeling and information to be supplied

IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

ISO 27185:2012/(R)2017, Cardiac rhythm management devices – Symbols to be used with cardiac rhythm management device labels, and information to be supplied – General requirements

ASTM F2503, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

IEC TR 60878:2015, Graphical symbols for electrical equipment in medical practice}

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SYMBOLS GLOSSARY