When used to indicate an instruction to consult an electronic instructions for use (eIFU), this symbol is accompanied by an eIFU indicator. This indicator may represent the manufacturer’s eIFU website or any other appropriate indication on the use of eIFU. The indicator may be placed either alongside, beneath or surrounding the symbol.

Symbol Standard Ref # Title Description ISO 15223-1 Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied 5.2.4 Sterilized using irradiation Indicates a medical device that has been sterilized using irradiation. ISO 15223-1 Medical devices – Symbols to be used with medical device

We are currently integrating the new UDI code on our labels as part of the Unique Device Identification (UDI) System. UDIs are required only in the United States so far, but will become mandatory in Europe when the new IVDR comes into effect.

The ISO 15223-1:2021 version includes a “UDI” symbol. Is it needed to be put along with the UDI carrier on the Label ? This depends on the medical device manufacturer’s label.

Include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative. If a device is intended for more than one use and...

Aug 16, 2021 · Accurate UDI scanning is important to ensure improvements in electronic medical device adverse event reporting, recall tracking, electronic patient health record accuracy, and efficient charge capture and billing. The recent ISO 15223-1:2021 advocates for new UDI symbol that addresses this.

When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernize...

ISO 15223:2020 will be soon published and will bring new symbols for labelling of medical devices. New symbols for UDI and much more.

ifu.origen.com. ISO 15223-1, Clause 5.4.3. ... Non-harmonized Symbol. Freezing Bag. Indicates that the product is intended for freezing at cryogenic temperatures. Values displayed to the right of the image indicate the validated freeze volume. ISO 3826-2, Clause 4.4.7.

Oct 31, 2021 · #8: Is the UDI symbol optional and can the UDI carrier be added without the UDI symbol? #9: Why is the IFU considered the lowest level of risk mitigation while the “blue man” safety sign is considered a primary risk control measure?