MEDICAL DEVICE WITH LABELING AND METHOD FOR ATTACHING A LABEL TO A MEDICAL DEVICE

Description

[0001] The present invention relates to a medical product comprising a transparent area and a marking.

[0002] The EU, through Directive 2011 / 62 / EU, mandated measures to identify counterfeit medicines and prevent their infiltration into supply chains. Similar requirements apply to medical devices under the Medical Device Regulation (EU) 2017 / 745, which requires a Unique Device Identifier (UDI) for marking. Printing on a film, such as a pouch, is technically challenging, particularly with regard to potentially leachable components. Publications EP2806004A1 and JP2004231915A address the topic of printing on films. CN106274118A discloses a hot stamping foil for applying a marking to a medical pouch.

[0003] The present invention is therefore based on the objective of creating a medical product and a method in which a marking adheres well, withstands a sterilization process and is resistant to disinfectants.

[0004] Apart from that, the strict requirements for pharmaceuticals regarding extractables / leachables must be met over the lifetime, etc.

[0005] This problem is solved by a medical product according to claim 1 and by a method according to claim 8.

[0006] The medical product is then provided to be a bag containing fresh or used dialysis solution or dialysis concentrate or a drug in solid or liquid form, and that a hot stamping foil is located on the transparent area, and that a thermal transfer foil is located on the hot stamping foil, which in turn has a marking, the marking being of a different color than the hot stamping foil and the marking including serialization information.

[0007] In a preferred embodiment, the transparent area is itself a film, e.g., a bag film. The hot stamping foil is applied to this, and finally the thermal transfer foil is applied to this.

[0008] The latter consists of the marking or at least exhibits it.

[0009] According to the invention, the medical product is a bag, such as those used in dialysis treatment. The invention states that the bag contains dialysis concentrate or solution, or a medication, or is a bag for collecting used dialysis solution.

[0010] The marking can be, for example, a code such as a barcode or a matrix code.

[0011] Alternatively or additionally, the labeling can be plain text information, such as an article name.

[0012] Labeling using a code or plain text is serialization information, e.g., coded or in plain text. The printing process must therefore be capable of printing variable data.

[0013] To ensure sufficient contrast, the hot stamping foil preferably has a lighter color than the thermal transfer foil.

[0014] It is conceivable that the hot stamping foil is white in sections or entirely, and that the thermal transfer foil is black in sections or entirely.

[0015] To ensure a sufficient lifespan for the marking, the thermal transfer foil can be designed to withstand a sterilization process of the medical product. This preferably means that the marking can withstand temperature treatment at 124°C or higher.

[0016] Other preferred properties of the marking include good adhesion to transparent surfaces, such as bags, tubes, etc., and / or resistance to disinfectants and / or the absence of extractables / leachables over its lifetime.

[0017] According to the invention, the medical product is a bag containing fresh or used dialysis solution or a dialysis concentrate or a drug in solid or liquid form.

[0018] The present invention further relates to a method for manufacturing a medical product according to one of claims 1 to 7, wherein the hot stamping foil is first applied to the transparent area in a hot stamping process and wherein the thermal transfer foil is applied to the hot stamping foil in a further step.

[0019] It should be noted that the terms "ein" and "eine" do not necessarily refer to exactly one of the elements, although this is a possible interpretation, but can also denote a plurality of the elements.

[0020] Likewise, the use of the plural also includes the presence of the element in question in the singular, and conversely, the singular also includes several of the elements in question.

[0021] Further details and advantages are explained in more detail using an exemplary embodiment shown in the drawing.

[0022] The single figure shows a hot stamping foil on a bag with a marking arranged on it, consisting of a thermal transfer foil.

[0023] The bag or transparent film is marked with reference numeral 10 in the figure.

[0024] The hot stamping foil 20, which is white, is applied to this bag material.

[0025] The actual marking is formed by a thermal transfer foil 30, which is located on the hot stamping foil.

[0026] The thermal transfer foil comprises or consists of the marking, which in the exemplary embodiment is represented both as code 40 and as plain text marking 50.

[0027] The serialization identifier (DataMatrix code + plain text information) must be easily readable; therefore, a minimum quality is required (grading according to ISO 15415); in addition, variable data must be able to be printed (e.g., randomized serial number as content of the code).

[0028] To ensure good readability, a high contrast is needed; therefore, a black code is preferably printed on a white background.

[0029] Because the bag film is transparent, a white background is first applied to the bag using a hot stamping process. Then, the code and human-readable information are printed in black using a thermal transfer process. This method allows for the printing of variable data.

[0030] The bag is preferably a bag containing a dialysis solution, or a concentrate for a dialysis solution, a bag for receiving a used dialysis solution, etc.

Claims

1. Medical device having a transparent region and a label, the medical device consisting of a bag (10) that contains a fresh or used dialysis solution or a dialysis concentrate or a medicament in solid or liquid form, characterized in that a hot stamping film (20) is located on the transparent region (20) and in that a thermal transfer film (30) which itself has a label (40, 50) is located on the hot stamping film (20), the label having a color different from that of the hot stamping film (20), and the label (40, 50) comprising serialization information (40).

2. Medical device according to claim 1, characterized in that the transparent region is a film.

3. Medical device according to any one of the preceding claims, characterized in that the label consists of a code or in that the label comprises a code.

4. Medical device according to any one of the preceding claims, characterized in that the label consists of a piece of clear-text information or in that the label comprises a piece of clear-text information.

5. Medical device according to any one of the preceding claims, characterized in that the hot stamping film has a lighter color than the thermal transfer film and / or than the label.

6. Medical device according to any one of the preceding claims, characterized in that the hot stamping film is white sectionally or overall and in that the thermal transfer film or the label is black sectionally or overall.

7. Medical device according to any one of the preceding claims, characterized in that the thermal transfer film is configured to withstand a sterilization process of the medical device.

8. Method of manufacturing a medical device according to any one of claims 1 to 7, characterized in that the hot stamping film is first applied to the transparent region of the medical device in a hot stamping process and in that the thermal transfer film, presenting the label or consisting of the label, is applied to the hot stamping film in a further step.