MARKING MEDICAL DEVICES
Sensitive information in aggressive environments
Throughout the lifespan of the product, identification and traceability data is subject to various forms of attack able to affect the legibility of the information:
- Certain sterilization processes such as autoclave subject the inks to a stern test, combining humidity with high temperatures. These conditions favour information becoming erased during contact with other products or during handling.
- In the hospital environment, the use of alcohol solutions during patient care may degrade the printed matter on medical device labels during handling.
Complying with labelling regulations
In the USA for example, the UDI (Unique Device Identification) system requires a unique traceability code, a barcode and a representation of the product on the label for every medical device.
Thermal Transfer enables unitary printing of labels with all types of barcodes, logos, product drawings and other small characters: a guaranteed flexibility for medical device manufacturers.
Medical device manufacturers wishing to sell their products in the USA must submit a Drug Master File to the FDA to validate the safety of all of the product’s components, including printing inks. ARMOR supports users in this area by making ink composition information available to the FDA.
CISON ribbons for medical devices
CISON’s resin-based offers the best combination of print quality and resistance.
CISON’s inks comply with some of the most demanding regulations in terms of human health:
- No heavy metals (2002/95/EC)
- Suitable for food contact: Europe (1935/2004) and USA (FDA)
- No Biphenol A or S
- No SVHCs (REACH)
Resin-based inks from the range are compatible with labels made of coated papers, synthetics and textiles, including specialist materials used in sterilization such.
The expertise Armor
- Ideal for the individual traceability of each device
- The ribbons are compatible with paper and synthetic labels
- Inks with a Drug Master File number
