Product Symbols

And Their Meanings

Wherever possible and appropriate, we use internationally harmonized symbols to communicate important product instructions and precautions.Our labeling is designed to meet the following standards: 21 CFR 820.120, 21 CFR 801, ISO 13485 section 3.6, BS EN ISO 15223-1, BS EN 1041, applicable sections of the Canadian Medical Device Regulation and other international standards/regulations. Below is a complete listing of the symbols used.

SYMBOLS GLOSSARY

Standard: ISO 15223-1, Medical Devices – Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: General requirements

Symbol Reference No	Title of Symbol	Description of Symbol
5.1.1	Manufacturer	表明s the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
5.1.2	Authorized representative in the European Community	表明s the authorized representative in the European Community.
5.1.3	Date of manufacture	表明s the date when the medical device was manufactured.
5.1.4	Use by date	表明s the date after which the medical device is not to be used.
5.1.5	Batch code	表明s the manufacturer's batch code so that the batch or lot can be identified.
5.1.6	Catalog number	表明s the manufacturer's catalog number so that the medical device can be identified.
5.1.7	Serial number	表明s the manufacturer's serial number so that a specific medical device can be identified.
5.1.8	Importer	表明s the entity importing the medical device into the locale.
5.1.9	Distributor	表明s the entity distributing the medical device into the locale.
5.2.3	Sterilized using ethylene oxide	表明s a medical device that has been sterilized using ethylene oxide.
5.2.4	Sterilized using irradiation	表明s a medical device that has been sterilized using irradiation.
5.2.6	Do not resterilize	表明s a medical device that is not to be resterilized.
5.2.7	Nonsterile	表明s a medical device that has not been subjected to a sterilization process.
5.2.8	Do not use if package is damaged.	表明s a medical device that should not be used if the package has been damaged or opened.
5.3.2	Keep away from sunlight	表明s a medical device that needs protection from light sources.
5.3.4	Keep dry	表明s a medical device that needs to be protected from moisture.
5.3.7	Temperature limit	表明s the upper and lower limits of temperature to which the medical device can be safely exposed. The temperature is indicated adjacent to the horizontal lines.
5.3.6	Upper limit of temperature	表明s the upper limit of temperature to which the medical device can be safely exposed. The temperature is indicated adjacent to the upper horizontal line.
5.3.5	Lower limit of temperature	表明s the lower limit of temperature to which the medical device can be safely exposed. The temperature is indicated adjacent to the lower horizontal line.
5.4.1	Biological risk	表明s that there are potential biological risks associated with the medical device.
5.4.2	Do not reuse	表明s a medical device that is intended for one use or for use on a single patient during a single procedure.
5.4.3	Consult instructions for use	表明s the need for the user to consult the instructions for use.
5.4.4	Caution	表明s that the instructions for use contain important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.
5.4.5	Contains or presence of natural rubber latex	表明s the presence of natural rubber or dry natural rubber latex as a material of construction within the medical device or the packaging of a medical device, which may cause allergic reactions.
5.4.7	Contains a medicinal substance	表明s a medical device that contains or incorporates a medicinal substance.
5.4.10	Contains hazardous substances	表明s a medical device that contains substances that can be carcinogenic, mutagenic or reprotoxic (CMR), or substances with endocrine-disrupting properties.
5.4.12	Single patient multiple use	表明s a medical device that may be used multiple times (multiple procedures) on a single patient.
5.6.3	Non-pyrogenic	表明s a medical device that is non-pyrogenic.
5.7.1	Patient number	表明s a unique number associated with an individual patient.
5.7.2	Patient name	表明s the name of the patient.
5.7.3	Patient identification	表明s the identification data of the patient.
5.7.4	Patient information website	表明s a website where a patient can obtain additional information on the medical product.
5.7.5	Health care center or doctor	To indicate the address of the health care center or doctor where medical information about the patient may be found.
5.7.6	Date	To identify the date that information was entered or a medical procedure took place.
5.7.7	Medical device	表明s the item is a medical device.
5.7.8	Translation	To identify that the original medical device information has undergone a translation that supplements or replaces the original information.
5.7.9	Repackaging	To identify that a modification to the original medical device packaging configuration has occurred.
5.7.10	Unique Device Identifier	表明s a carrier that contains Unique Device Identifier information.
5.2.11 (ISO 15223-1:2021)	Sterile barrier system	表明一个无菌屏障系统。
5.2.12 (ISO 15223-1:2021)	Sterile barrier system	表明s a double sterile barrier system.
5.2.13 (ISO 15223-1:2021)	Sterile barrier system	表明s a single sterile barrier system with protective packaging inside.
5.2.14 (ISO 15223-1:2021)	Sterile barrier system	表明s a single sterile barrier system inside protective packaging.
ASTM F2503 § 7.4.9	MR unsafe	表明s that the device is not MR safe and should remain outside of the 5G field.
IEC 60417 Symbol 5335	Applied part	表明s a type CF Applied part.
IEC 60529	Ingress protection code 22	Vertically dripping water will not cause a hazard.
ISO 7010 Symbol M002	ISO 7010-M002	Refer to instruction manual.

Symbol	Standard/ Symbol Reference No.	Title of Symbol	Description of Symbol
RxOnly	21 CFR 801.109	The symbol statement for prescription device	表明s 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).
	European Medical Devices Directive 93/42/EEC June 14, 1993 (as amended by Directive 2007/47/EC), as described in Article 17 of the Directive	Conformité Européene or European conformity	表明s manufacturer declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.
	IEC 60417, Graphical symbols for use on equipment Symbol Reference No: 5840	Type B applied part	表明s a type B applied part complying with relevant section of the technical standard IEC 60601-1 for safety of medical electrical equipment.
	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; and 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.
OR	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 Union's 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 August 13, 2005.
	BS EN 15986, Symbol for use in the labeling of medical devices Requirements for labeling of medical devices containing phthalates as described in Section 4.2 of the Standard	Contains or presence of phthalate DEHP	本产品包含Di (2-ethlhexyl)邻苯二甲酸二(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.
	BS EN 15986, Symbol for use in the labeling of medical devices Requirements for labeling 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	表明s product that does not contain the phthalate plasticizers DEHP, DIBP, DBP or BBP.
	BS EN 15986, Symbol for use in the labeling of medical devices Requirements for labeling of medical devices containing phthalates as described in Section 4.2 and Annex B of the Standard	Does not contain the phthalate plasticizer DEHP	表明s product that does not contain the phthalate plasticizer DEHP.

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