Safety information on the symbols used

The symbols and their contents are excerpts from relevant standards and publications. Normative content subject to change.



 

ABC123

expiration date Symbol: 5.1.4 in accordance with DIN EN ISO 15223-1
Displays the date after which the medical device must no longer be used. This icon is accompanied by a date. After the specified year, month, day the device should not be used anymore.



 

ABC123

Batch code Symbol: 5.1.5 in accordance with DIN EN ISO 15223-1
Displays the manufacturer's batch number, so that the batch or lot can be identified. The batch code must be placed close besides the symbol.



 

ABC123

Article number Symbol: 5.1.6 in accordance with DIN EN ISO 15223-1
Displays the manufacturer's order number, so that the medical device can be identified. The order / SKU is added to this symbols. The order/ item number follows directly to the symbol.



 

ABC123

Serial number Symbol: 5.1.7 in accordance with DIN EN ISO 15223-1
Displays the serial number of the manufacturer, so that a particular medical device can be identified. The serial number is next to the icon.



   
Sterile Symbol: 5.2.1 in accordance with DIN EN ISO 15223-1
Displays a medical product which has been sterilized with Ethylene Oxide.



   
Non-sterile Symbol: 5.2.7 in accordance with DIN EN ISO 15223-1
Shows a medical device which has not been exposed to sterilization processes. This symbol is used only in order to distinguish between identical or similar medical devices, which are sold in both the sterile and the non-sterile condition. The symbol will not be used for non-sterile bulk products.



   
Do not use if package is damaged Symbol: 5.2.8 in accordance with DIN EN ISO 15223-1
Displays a medical product that should not be used if the packaging is damaged or opened. If package is damaged, the sterility and pyrogen-free is no longer guaranteed.



   
Do not reuse Symbol: 5.4.2 8 in accordance with DIN EN ISO 15223-1
Refers to a medical product that is intended for single use or use on a single patient during a single treatment. In the case of reusing the risk of infection exists.



   
Note Important information Symbol: 5.4.3 in accordance with DIN EN ISO 15223-1
Refers to observe the need for the user information. The user is obliged to observe the instructions.



   
Follow instructions Symbol: 5.4.4 in accordance with DIN EN ISO 15223-1
Refers to the need for the user, the instructions on important security-related information(data) to see through how warning hints and precautions which cannot be attached (by huge number of reasons) on the medicine product themselves.



   

Contains or presence of phthalates Symbol in accordance DIN EN ISO 15223-1
The symbol refers to an ingredient or the presence from Phthalates. The present Phthalates are added to this symbol. The used Phthalates are listed in short form under or beside the symbol individually.

DEHP = Diethylhexylphthalat or Bis(2-ethylhexyl)phthalat

use:     The Phthalate DEHP can find in medicine products of PVC plastic or in isolated PVC plastic to components of medicine products as a use.

problem:     The DEHP can be dissolved out of the plastic. The only prerequisite is that a DEHP plastic with a DEHP-dissolving substance has contact. The DEHP is an SVHC substance and is in accordance with REACH Regulation "endangering reproduction" and therefore classified as listed.

risk group:    
  • Children before end of the gender maturity
  • Early and newborn children
  • Babies and toddlers
  • Children and youngsters up to the puberty
  • Pregnant women
  • Breastfeeding