ISO 15223-1 MD symbols

Manufacture

  • 5.1.1 : Manufacturer (+ name and address)
  • 5.1.2 : Authorized representative in the European Community / European Union (+ name and address)
  • 5.1.8: Importer (+ name and address)
  • 5.1.9: Distributor (+ name and address)
  • 5.1.11: Country of manufacture (the CC in the symbol shall be replaced 2 or 3-letter country code)

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Identification of product

  • 5.1.5: Batch code = lot code = batch number
  • 5.1.6: Catalogue number = reference number = reorder number = commercial product code
  • 5.1.7: Serial number
  • 5.1.10: Model number

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User information

  • 5.1.3: Date of manufacture
  • 5.1.4 : Use-by date : the date after which the device is not to be used (after the end of the year, month or day shown)
  • 5.2.8: Do not use if package is damaged and consult instructions for use
  • 5.4.3: Consult instructions for use
  • 5.4.4: Caution

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Safe use

  • 5.4.1: Biological risk
  • 5.4.5: Contains or presence of natural rubber latex as material of construction within the medical device or the packaging of it.
  • 5.4.10: Contains hazardous substance(s)
  • 5.4.2: Do not re-use = medical device is intended for single use only = use only once
  • 5.4.12: single patient multiple use: the medical device may be used multiple times on a single patient

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Sterility

  • 5.2.1: Sterile: indicates that a medical device has been subjected to a sterilization process.
  • 5.2.2: Sterilized using aseptic processing techniques
  • 5.2.3: Sterilized using ethylene oxide
  • 5.2.4: Sterilized using irradiation
  • 5.2.5: Sterilized using steam or dry heat
  • 5.2.6: Do not resterilize (only to be used when there is also the sterile symbol)
  • 5.2.7: Non-sterile (to be used only to distinguish between identical or similar medical devices sold in both sterile and non-sterile conditions)
  • 5.2.12: double sterile barrier system

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Storage conditions

  • 5.3.1: Fragile, handle with care
  • 5.3.2: Keep away from sunlight = keep away from heat
  • 5.3.3: Protect from heat and radiation sources
  • 5.3.4: Keep dry = keep away from rain
  • 5.3.5: Lower temperature limit (+ temp limit adjacent to lower horizontal line)
  • 5.3.6: Upper temperature limit (+ temp limit adjacent to upper horizontal line)
  • 5.3.7: Temperature limit (+ temp limits adjacent to both horizontal lines)
  • 5.3.8: Humidity limitation (+ limits adjacent to both horizontal lines)
  • 5.3.9: Atmospheric pressure limitation + limits adjacent to both horizontal lines)

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IVD-specific

  • 5.5.1: In vitro diagnostic medical device
  • 5.5.2: Control material intended to verify the performance of another medical device
  • 5.5.3: Negative control
  • 5.5.4: Positive control
  • 5.5.5: Contains sufficient for “n” tests

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Transfusion / infusion

5.6.2: Fluid path present (liquid or gas)

5.6.3: Non-pyrogenic

5.6.4: Drops per milliliter: the number of drops to be specified in the symbol

5.6.5: Liquid filter with pore size: the infusion or transfusion system of the medical device contains a filter of a particular nominal pore size (size indicated in the symbol)

5.6.6: One-way valve: the flow is only possible in one direction and cannot be reversed

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General / other

  • 5.7.7: Medical Device
  • 5.7.9: Repackaging (+ name + address of unit responsible for repacking, if not by manufacturer)
  • 5.7.10: Unique Device Identifier

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