EHOB labeling is designed to meet all applicable standards and regulations. Where possible, EHOB uses symbols to communicate product requirements, characteristics, and guidance on handling and storage for those who use or handle our products. Descriptions are updated regularly; for the latest version of each symbol's description, please refer to the relevant ISO standards on their official website here: https://www.iso.org/home.html
Three symbols are not created by a Standard Development Organization: Toes Up, "Multi-patient multi-use" and Size. These will have their descriptions only found on this page.
Symbols that may appear on the product labeling and the meaning of the symbol is provided below.
SINGLE-PATIENT SINGLE-USE
(INFORMALLY AS 'DO NOT RE-USE')
Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref. no: 5.4.2
DATE OF MANUFACTURE
Indicates the date when the medical device was manufactured.
This symbol is associated with a date that describes when the medical device was manufactured. This shall be expressed as in ISO 8601 as four digits for the year and, where appropriate, two digits for the month and two digits for the day. The date shall be located adjacent to the symbol.
MANUFACTURER
Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 9 8/ 79/ E C.
This symbol identifies the entity responsible for designing, manufacturing, packaging, and labeling of a medical device before it is released to the market. It typically includes the manufacturer's name and address.
Catalogue number (informally product code)
This symbol is associated with an alphanumeric sequence used to identify the specific product model or variant of a medical device.
The manufacturer’s catalog number shall be adjacent to the symbol.
LOT NUMBER (OR BATCH CODE)
Indicates the manufacturer’s batch code so that the batch or lot can be identified.
This symbol is associated with an alphanumeric sequence that represents a batch or group of products manufactured under the same conditions. It allows for traceability in case of recalls or quality issues. The batch code shall be adjacent to the symbol.
NON-DEHP
This symbol indicates that the product does not contain di(2-ethylhexyl) phthalate (DEHP).
NON-LATEX
This symbol indicates that the product does not contain natural rubber latex.
NON-BPA
This symbol indicates that the product does not contain bisphenol A (BPA).
USE-BY-DATE
This symbol specifies the last date the product is guaranteed to function as intended. Using the device after this date may compromise safety or effectiveness.
SERIAL NUMBER
This symbol is associated with a unique identifier assigned to an individual medical device, and aids in tracking and distinguishing products.
TEMPERATURE LIMIT
This symbol specifies the safe temperature range in which the medical device should be stored or used. Exceeding this range could affect the device’s functionality.
HUMIDITY LIMITATION
This symbol indicates the acceptable humidity conditions for storage or usage. Excess moisture may degrade materials or affect device performance.
ATMOSPHERIC PRESSURE LIMITATION
This symbol shows the minimum and maximum atmospheric pressure the device can withstand without malfunctioning.
CONSULT INSTRUCTIONS FOR USE OR CONSULT ELECTRONIC INSTRUCTIONS FOR USE
This symbol informs users that they should read the provided instructions before using the device to ensure proper and safe operation.
MEDICAL DEVICE
This symbol identifies a product as a medical device, distinguishing it from general consumer products.
TYPE BF APPLIED PART
This symbol indicates that the device provides a degree of protection against electrical shock when applied to a patient but is not directly connected to the heart.
REFER TO INSTRUCTION MANUAL/BOOKLET
This symbol directs users to consult the manual for important safety and usage information.
MR SAFE
This symbol denotes that the device is safe for use in an MRI environment, meaning it does not pose risks like movement, heating, or interference.
MR UNSAFE
This symbol warns that the device must not be used in an MRI environment as it may contain ferromagnetic materials or electronics that pose a hazard.
CE MARKING
This symbol indicates that the medical device complies with European Union regulations and is approved for sale within the EU market.
CHINA EXPORT
This symbol indicates that the product is exported from China.
SIZE
This symbol is associated with identifying the product's size.
MULTIPLE-PATIENT MULTIPLE-USE
This symbol indicates that the device can be used for multiple patients.
CAUTION
This symbol alerts the user to a potential safety warning that should be reviewed before using the device.
TOES UP SYMBOL
This symbol indicates that the product must be positioned with the toes pointing upward to ensure proper function and effectiveness.
COUNTRY OF ORIGIN
This symbol identifies the country where the product was manufactured, where the characters in the center are a country code is defined by ISO 3166-1 alpha-2.
SINGLE-PATIENT MULTIPLE-USE
This symbol indicates that the device is intended for use by a single patient but can be reused for that patient multiple times.
FRAGILE; HANDLE WITH CARE
This symbol warns that the product is fragile and should be handled gently to avoid damage.
THIS WAY UP
This symbol indicates the correct orientation for storing or transporting the package to prevent mishandling.
KEEP DRY
This symbol informs users that the product must be kept away from moisture to prevent damage or degradation.
MODEL NUMBER
This symbol is associated with an alphanumeric sequence used to identify the specific product model or variant.
