Symbol | Standard/ Symbol Reference No. | Title of Symbol | Description of Symbol |
---|---|---|---|
RxOnly | 21 CFR 801.109 | The symbol statement for Prescription Device | Indicates that the product is a medical device as defined in 21 CFR 820.3(l) and Federal Law (USA) restricts this device to sale by or on the order of a physician (21 CFR 801.109) |
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European Medical Devices Directive 93/42/EEC of 14 June 1993 (as amended by Directive 2007/47/EC) as described in Article 17 of the Directive | Conformité Européene or European Conformity | Indicates manufacturer declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation. |
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IEC 60417, Graphical symbols for use on equipment Symbol Reference No: 5840 | Type B Applied Part | Indicates a type B applied part complying with relevant section of the technical standard IEC 60601-1 for safety of medical electrical equipment. |
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ASTM F2503-13, Standard Practice for Marking Medical Devices and Other Items for Safety In the Magnetic Resonance Environment. As described in Section 7.4.6 of the Standard | MR Conditional | Medical device that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. Field conditions that define the MR environment include static magnetic field strength; spatial gradient, time rate of change of the magnetic field (dB/dt), RF fields, and specific absorption rate (SAR). These conditions are identified on all appropriate product labeling. |
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BS EN 50419, Marking of Electrical and Electronic Equipment in accordance with Article 11(2) of the European Community Directive 2002/96/EC (WEEE) | Crossed out Wheelie-Bin |
Identifies product that is subject to the European Unionís Waste Electrical and Electronic Equipment (WEEE) 2012/19/EU Directive for recycling of electronic equipment.
The black bar underneath the bin indicates goods that were placed on the market after 13 August 2005. |
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BS EN 15986, Symbol for use in the labelling of medical devices
Requirements for labelling of medical devices containing phthalates as described in Section 4.2 of the Standard |
Contains or presence of phthalate DEHP | This product contains Di(2-ethlhexyl)phthalate (DEHP) which has been shown to cause reproductive harm in male neonates, pregnant women carrying male fetuses, and peripubertal males. The following procedures have been identified as posing the greatest risk for DEHP exposure: exchange transfusion in neonates, total parenteral nutrition (TPN) in neonates (with lipids in polyvinylchloride (PVC) bag), multiple procedures in sick neonates (high cumulative exposure), heart transplantation or coronary artery bypass graft surgery (aggregate dose), and massive infusion of blood into trauma patient. It is recommended that DEHP-free medical products be considered when these procedures are to be performed on male neonates, pregnant women who are carrying male fetuses, and peripubertal males. |
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BS EN 15986, Symbol for use in the labelling of medical devices
Requirements for labelling of medical devices containing phthalates as described in Section 4.2 and Annex B of the Standard |
Does not contain the phthalate plasticizers DEHP, DIBP, DBP, or BBP | Indicates product that does not contain the phthalate plasticizers DEHP, DIBP, DBP, or BBP. |
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BS EN 15986, Symbol for use in the labelling of medical devices
Requirements for labelling of medical devices containing phthalates as described in Section 4.2 and Annex B of the Standard |
Does not contain the phthalate plasticizer DEHP | Indicates product that does not contain the phthalate plasticizer DEHP. |
Rev. 0816