Sterile packaging for sterile medical products.

Abstract

The invention relates to a sterilized packaging for sterilized medical products, in particular implants, which has at least one or, in the case of multiple sterilized packaging, at least one first internal sterilized barrier and a second external sterilized barrier that is separate and independent of the first sterilized barrier, and which is accommodated in a secondary packaging. According to the invention, the secondary packaging of such sterilized packaging consists of a composite material, including cardboard and at least one lining or foil, and is designed and provided to form the second sterilized barrier of the sterilized packaging.

Description

1 / 17 Sterile packaging for sterile medical products. Technical field

[0001] This disclosure refers to a sterilized package with preferably an internal sterilized first barrier and an external sterilized second barrier (mandatory), which is formed separately and independently of any existing sterilized first barrier, for the proper packaging of sterilized medical products, in particular implants. Fundamentals of the invention

[0002] Medical products, such as implants, must be stored in appropriate packaging that prevents contamination by microorganisms until they are used. In general, certain official standards apply to the packaging of medical products or sterilized products, such as DIN EN ISO 11607 Part 1 and Part 2 and EN 868 2-10, whose requirements must be met by manufacturers of medical products and also by healthcare facilities, such as hospitals, in order to ensure adequate and safe packaging that is adapted to the respective medical product. For example, DIN EN ISO 11607 Part 1 describes the general requirements for materials, sterilized barrier systems and packaging systems.

[0003] When selecting the correct packaging, several aspects play a decisive role, such as the nature of the medical product to be packaged, user requirements, structural conditions, and transport logistics. However, a corresponding aspect of ease of use and safety is also of great importance. For example, the packaging must ensure easy filling with the product and a germ-proof seal, while also being robust enough to prevent damage. Proper labeling of the packaging or contents and sterilization of the packaging must also be possible. Since the loss of Petition 870220054988, dated 06 / 23 / 2022, page 8 / 27 2 / 17 The sterility of a medical product depends less on the storage period than on external influences and impacts during transport and storage; therefore, the packaging of a medical product must also be selected in relation to the transport and storage conditions of the respective medical product. For example, repeated handling of transparent packaging can cause material breakage, loosening of the sealing seam, channel formation, or perforations.

[0004] Implants such as knee or hip implants are usually packaged in a double-sterile manner. This means that the respective implant is packaged in two successive blister packs, sterile bags, a combination of both, or something similar to allow for aseptic / germ-free presentation in the operating room. In practice, the correct aseptic presentation of double-sterile packaged medical products during surgery requires two operating room nurses, in addition to the physician who ultimately inserts the medical product into the patient or uses it during the course of the surgery. One of the two operating room nurses assumes the non-sterile role, i.e., opening an existing secondary package in which the double-sterile packaged medical product is contained and opening the outer blister pack, shell bag, etc., which is formed as a second sterile barrier, while the other of the two operating room nurses takes on the sterile role and is responsible for the correct opening of the inner blister pack, shell pouch, etc., which is formed as the first sterile barrier.

[0005] However, simple sterilized packaging is also sufficient for certain medical products, such as tissue adhesives, but also disposable scalpels or some products used in spinal surgery.

[0006] Currently, so-called composite packaging is used in almost the entire food packaging sector. The packaging Petition 870220054988, dated 06 / 23 / 2022, page 9 / 27 3 / 17 Composite is made of bonded / composite materials, meaning they consist of two or more materials bonded together that have material properties different from the individual material components and even exceed the properties of the individual material components. Since a single material cannot offer all the desired properties, different materials are combined to form a composite that has the desired properties and at the same time meets the requirements for packaging in the food industry.

[0007] The most commonly known example of composite packaging in the food industry is beverage cartons or, respectively, disposable packaging for beverages or liquid foods. They consist of cardboard and plastic, and often a thin layer of aluminum, which are bonded across the entire surface and cannot be separated by hand. Such a structure protects against light and oxygen and, in this way, suppresses or, respectively, slows down the oxidation processes and the destruction of vitamins and aromas of the packaged foods outside the cold chain.

[0008] In view of the wide advantages that composite packaging can offer, depending on its composition, the use of composite packaging or composite materials also seems to make sense in the packaging of sterilized medical products and, in particular, for implants, in order to meet the numerous requirements placed on the packaging of medical products in an efficient manner. State of the Art

[0009] A currently common state-of-the-art packaging solution is the two-barrier sterilized packaging of medical products. This sterilized packaging is used by most medical product manufacturers and consists of a first internal sterilized barrier and a second external sterilized barrier, where blister packs, sterile bags, etc. are used to form / create both barriers. Petition 870220054988, dated 06 / 23 / 2022, page 10 / 27 4 / 17 sterilized. That is, a sterilized medical product to be packaged is placed in an inner blister pack, shell pouch, etc. formed as a first sterilized barrier. This inner blister pack, shell pouch, etc. is, in turn, inserted into an outer blister pack, shell pouch, etc. formed as a second sterilized barrier. This outer blister pack, sterile bag, etc., which contains the inner blister pack, sterile bag, etc. and the sterilized medical product located inside, is then placed in an outer box, which may be additionally padded for better protection during transport. Finally, the secondary packaging may also be wrapped in cellophane for protection.

[0010] In order to present a medical product packaged in a double-sterilized manner during an operation, both a non-sterile operating room nurse and a sterile operating room nurse are required, as mentioned above. The 'non-sterile operating room nurse' first removes the cellophane around the packaging, if present, in an area not sterilized during the operation and opens or unfolds the packaging, thus presenting the double-sterile packaged medical product. The non-sterile operating room nurse then removes, from the outer box, the double-sterile medical product or, more precisely, the outer blister pack, sterile bag, etc., formed as a second sterile barrier, containing the inner blister pack, sterile bag, etc., formed as a first sterile barrier and the sterile medical product contained therein.Now, the outer blister pack, shell pouch, etc., formed as the second sterile barrier, is aseptically opened by the 'non-sterile operating room nurse,' and the inner blister pack, shell pouch, etc., formed as the first sterile barrier, is handed / presented to the 'sterile operating room nurse,' who is located in a sterile area. A. Petition 870220054988, dated 06 / 23 / 2022, page 11 / 27 5 / 17 The inner blister packaging, sterile bag, etc., formed as the first sterilized barrier, including the sterilized medical product contained within, is then removed by the operating room nurse from the opened outer blister packaging, sterile bag, etc., formed as the second sterilized barrier and opened in the sterilized area of ​​the operating room. The sterilized medical product inside is then handed to the operating physician and used on and / or the patient.

[0011] Upon opening the outer blister pack, sterile bag, etc. Formed as the second sterile barrier, the 'non-sterile operating room nurse' must ensure that the inner blister packaging, sterile bag, etc., formed as the first sterile barrier, is not rendered non-sterile by improper handling. Furthermore, both the 'non-sterile nurse' and the 'sterile nurse' must pay close attention during all the steps described above to ensure that the medical product remains sterile and does not fall on the floor or become damaged in any other way, since a non-sterile and / or damaged medical product should / should no longer be used on a patient. Additionally, common packaging, such as sterile bags, is tightly sealed, which is why they are very difficult to open or can only be opened by shaking. Operating room nurses, therefore, have to exert a relatively large amount of force to open them.These circumstances and the time pressure often present during operations generally lead to errors in the aseptic presentation of medical products or, respectively, to an undesirable complication of the aseptic presentation of medical products.

[0012] Double-packaged sterile medical devices according to the prior art also have a fairly large overall packaging effort and occupy a comparatively large packaging volume.

[0013] But even in the case of a single sterilized barrier, the sterilized packaged medical product is packaged in a Petition 870220054988, dated 06 / 23 / 2022, p. 12 / 27 6 / 17 additional redistribution / secondary packaging, preferably made of cardboard, which increases the overall packaging effort.

[0014] Therefore, there is a need for one or two sterile barrier packaging for sterilized medical products, particularly for implants, which allows for a simpler and less complicated aseptic presentation of sterilized medical products during surgery and, at the same time, requires significantly less packaging volume and generates less packaging waste than comparable sterile packaging from the state of the art. General description of the invention

[0015] In view of the problems described above, it is therefore a fundamental objective of the present invention to provide sterilized packaging with a single or double sterilized barrier for sterilized medical products, in particular implants, which, despite the additional secondary packaging, saves overall packaging material and / or packaging effort and thus significantly reduces packaging waste, on the one hand, and the costs incurred by the manufacturer for the packaging of medical products and the packaging process, on the other hand.

[0016] In this context, another objective of the present invention is to simplify the aseptic presentation of packaged sterilized medical products using a more practical opening mechanism and to avoid complicated unpacking of the medical product. At the same time, the present invention can reduce the individual unpacking steps of the non-sterile operating room nurse, which minimizes workload and results in time saved during an operation. Furthermore, the reduction in unpacking steps and the simplified opening mechanism also reduce the risk of the medical product being dropped, damaged, or generally rendered non-sterile during the unpacking process. Petition 870220054988, dated 06 / 23 / 2022, page 13 / 27 7 / 17

[0017] This object is resolved by a sterilized package with the characteristics of claim 1. Advantageous embodiments of the invention are the subject matter of the dependent claims.

[0018] Therefore, the central idea of ​​the present invention is not only to provide a sterilized package with a first sterilized (internal) barrier and preferably a second sterilized (external) barrier, which is contained in a corresponding secondary package, as is proposed in the prior art, but also to combine the properties and functions of the respective, if applicable, second external sterilized barrier (if present) and the secondary package using a special structure of the secondary package.

[0019] In other words, the secondary packaging of the sterilized package is designed as composite packaging, for example, in the sense of a beverage carton. In this way, several functions can be performed by the secondary packaging and, in addition to the respective (single) existing one, in the case of double packaging, the second external sterilized barrier can be formed in the secondary packaging. This simplifies the aseptic presentation of the medical product contained in the sterilized package during an operation, on the one hand, and also reduces the packaging volume and packaging material.

[0020] Specifically, a sterilized packaging is provided for sterilized medical products, in particular implants, comprising a first sterilized (internal) barrier and, if applicable, a second sterilized external barrier that is separate and independent from the first sterilized barrier and which is contained within a secondary packaging. According to the invention, the secondary packaging is made of a composite material, inter alia of cardboard and at least one liner or foil, and is configured and provided to form the single and, in the case of a double sterilized packaging, the second sterilized external barrier of the sterilized packaging. Furthermore, the sterilized packaging Petition 870220054988, dated 06 / 23 / 2022, page 14 / 27 8 / 17 according to the present invention can also be used for other sterilized products.

[0021] According to a further aspect of the invention, it is advantageous if the secondary packaging is additionally surrounded by cellophane. Compared to other plastics, cellophane is produced from renewable raw materials rather than fossil fuels and is compostable. This makes cellophane generally more environmentally friendly than conventional sheets used for packaging. Although cellophane is, on the one hand, waterproof, it also has the advantage of allowing water to pass through as vapor molecules, thus preventing water accumulation inside the sterilized packaging. In addition to its transparency, it also has excellent printing performance and can be printed with ordinary ink, making it well suited as a general packaging material or as an additional coating for packaging, respectively.

[0022] In order to guarantee a robust external (second) sterile barrier that meets the requirements for the packaging of medical products, the composite material of the secondary packaging according to another aspect of the invention consists of a multilayer composite, for example, in the sense of a beverage box, made of cardboard and a plastic sheet, in particular a polyethylene sheet. The cardboard gives shape and stability to the composite material and also provides a smooth surface for printing on the sterile packaging. In the case of double sterile packaging, the polyethylene sheet protects the inner packaging formed as the first sterile barrier and the medical product located inside it from moisture. According to a further aspect of the present invention, the composite material of the secondary packaging may also comprise a multilayer composite made of cardboard, a plastic sheet, in particular a polyethylene sheet, and an aluminum sheet.In this case, the polyethylene sheet serves not only as protection against moisture, but also as an adhesive layer between the cardboard and the aluminum foil. The goal. Petition 870220054988, dated 06 / 23 / 2022, p. 15 / 27 9 / 17 of the aluminum foil is to protect the contents, i.e., the medical product in the secondary packaging or, if applicable, in the inner packaging formed as the first sterilized barrier, from external influences such as extreme temperatures. The sterilized packaging can be specifically configured such that the multilayer compound consists, from the inside out, of cardboard, two layers of polyethylene foil, one layer of aluminum foil followed by another layer of polyethylene foil, one layer of paper, and an outer layer of polyethylene foil. The outermost polyethylene foil further protects the cardboard from immersion and increases the barrier properties of the multilayer compound. Alternatively, the multilayer compound may also have a different structure or, respectively, a different arrangement and may be variably designed depending on its function.

[0023] A further embodiment of the present invention is the integration of potentially gas-permeable areas into the multilayer composite in order to allow, in addition to a common sterilization method such as gamma sterilization, other common methods such as ethylene oxide sterilization.

[0024] In order to be able to open the secondary packaging and remove the sterilized medical product stored therein, which may be located in the inner packaging formed as a first sterilized barrier, the secondary packaging possibly formed as a second sterilized barrier of the sterilized packaging has a predetermined breaking point according to one aspect of the invention. According to a further aspect of the invention, the predetermined breaking point is located in the upper third of the secondary packaging possibly formed as a second sterilized barrier of the sterilized packaging. In this respect, according to yet another aspect of the invention, the predetermined breaking point is perforated. This ensures that the 'non-sterile operating room nurse' can open or fold it. Petition 870220054988, dated 06 / 23 / 2022, page 16 / 27 10 / 17 the secondary blister pack with relative ease and without complications. This mechanism for opening the secondary packaging simultaneously reduces the risk of the sterilized medical product, which may be in the inner packaging formed as the first sterilized barrier, falling to the ground and being damaged and therefore no longer usable.

[0025] In order to prevent the predetermined perforated rupture point from compromising the intact single or double sterilized barrier, the perforation should not include all layers. According to one aspect of the invention, therefore, with the exception of the innermost layer of the multilayer composite of the secondary packaging material, all layers of the multilayer composite are perforated. Alternatively, fewer or only certain layers of the multilayer composite may be perforated. In other words, more layers of the multilayer composite than just the innermost layer may be free from perforation.

[0026] According to another aspect of the invention, the predetermined breaking point may additionally be provided with a tear tab / removal tab. A tear tab / removal tab incorporated into the secondary packaging, in addition to the predetermined breaking point, provides an efficient alternative for easier and less complicated opening of the sterilized packaging.

[0027] Finally, in the case of a double sterilized package, the inner package configured as a first sterilized barrier, in which at least one sterilized medical product is contained, protrudes according to a further aspect of the invention when the secondary package formed as the second sterilized barrier is opened / folded. That is, an upper portion of the inner package formed as the first sterilized barrier projects above the open / folded secondary package configured as a second sterilized barrier. In this way, the inner package formed as the first sterilized barrier can be removed simply and easily by Petition 870220054988, dated 06 / 23 / 2022, page 17 / 27 11 / 17 operating room nurse sterilizes without having to enter the secondary packaging.

[0028] At this point, it should be explicitly pointed out that the above aspects, individually as well as in any combination with each other, can resolve the stated object and, therefore, are intended to be claimable individually or in any combination within the scope of this application. Brief description of the figures

[0029] The present invention is described in more detail below using preferred configuration examples with reference to the accompanying drawings. The following is shown: Fig. 1 shows a representation illustrating a sterilized package for sterilized medical products according to a first example configuration of the present disclosure; Fig. 2 shows a top view of an open sterilized package for sterilized medical products according to the first configuration example of the present disclosure; Fig. 3 shows a front view of the open sterilized packaging for sterilized medical products according to the first configuration example of this disclosure; Figure 4 shows a representation illustrating a sterilized package for sterilized medical products according to a second example configuration of this disclosure; and Fig. 5 shows an illustration of a typical secondary packaging structure of the sterilized package according to this disclosure. Description of configuration examples

[0030] Examples of configuration of this disclosure are described below based on the associated figures. Identical characteristics Petition 870220054988, dated 06 / 23 / 2022, pp. 18 / 27 12 / 17 or functionally equivalent figures are provided with the same reference symbols in the individual figures.

[0031] Fig. 1 shows a closed sterilized package 1 for sterilized medical products, in particular for implants, which has a first internal sterilized barrier 2, not shown in Fig. 1, and a second external sterilized barrier 3 formed separately and independently of the first sterilized barrier 2, and which is contained in a secondary package 4. The secondary package 4 consists of a composite material not shown in detail in Fig. 1, including a cardboard 5 and at least one liner or foil, and is configured and provided to form the second sterilized barrier 3 of the sterilized package 1.

[0032] Furthermore, the secondary packaging 4 formed as the second sterilized barrier 3 of the sterilized packaging 1 has a predetermined breaking point 9, which serves to open the secondary packaging 4. Since the secondary packaging 4 in Fig. 1 has not yet been opened / is closed, both the predetermined breaking point 9 and the second outer sterilized barrier 3 are still intact. The predetermined breaking point 9 is located in the upper third of the secondary packaging 4 formed as the second sterilized barrier 3 of the sterilized packaging 1, in order to facilitate the removal of an inner packaging 11 formed as the first sterilized barrier 2, which is located within the secondary packaging 4 formed as the second sterilized barrier 3. According to the first configuration example in Fig. 1, the predetermined breaking point 9 is reached by puncturing the secondary packaging 4.To avoid jeopardizing the second external sterilized barrier 3 in the case of pre-perforation and to ensure the sterility of the medical product contained in the secondary packaging 4, pre-perforation should not include all layers. That is, at least the innermost layer of the composite material is not perforated. Therefore, according to the present invention, with the exception of the innermost layer of the multilayer composite. Petition 870220054988, dated 06 / 23 / 2022, page 19 / 27 13 / 17 of the secondary packaging composite material 4, all layers of the multilayer composite are perforated. Alternatively, however, fewer or only certain layers of the multilayer composite may be perforated. In other words, more layers of the multilayer composite than just the innermost layer may be free of perforation.

[0033] In addition, the sterilized package 1 may be surrounded / wrapped in cellophane, which is not shown in Fig. 1, which further protects the sterilized package 1 from moisture due to its water-repellent properties and prevents water from accumulating inside the sterilized package 1. In practice, a non-sterile operating room nurse removes the cellophane that may surround the secondary package 4 and opens the secondary package 4 formed as the second sterilized barrier 3, folding / breaking the secondary package 4 at the predetermined breaking point 9. In this way, the second outer sterilized barrier 3 is also broken at the same time.

[0034] In Fig. 2, the sterilized packaging 1 according to the first example configuration of the present disclosure of Fig. 1 is shown in an open state from above. By opening or folding the secondary packaging 4 formed as the second sterilized barrier 3, at the predetermined breaking point 9, the intact inner packaging 11 formed as the first sterilized barrier 2, for example, in the form of a sterilized blister pack, shell pouch, etc., is exposed and can be removed by the 'sterilized operating room nurse'.

[0035] Fig. 3 shows the open sterilized package 1 according to the first configuration example of the present disclosure in Fig. 2 on the front. From this perspective, it becomes evident to what extent the arrangement of the predetermined breaking point 9 in the upper third of the secondary package 4 formed as the second sterilized barrier 3 is advantageous for removing the inner package 11 formed as the first sterilized barrier 2. In order to reduce the package volume and thus the Petition 870220054988, dated 06 / 23 / 2022, page 20 / 27 14 / 17 packaging waste production, the inner packaging 11 formed as the first sterilized barrier 2 and the secondary packaging 4 formed as the second sterilized barrier 3 are adapted to each other in terms of size / dimension, depending on the medical product to be packaged. This means that fairly small medical products, which are contained in an inner packaging 11 formed as the first sterilized barrier 2 appropriate for their size, are not contained in a disproportionately large secondary packaging 4 formed as the second sterilized barrier 3. This ensures that the inner packaging formed as the first sterilized barrier 2 projects beyond the open secondary packaging 4 formed as the second sterilized barrier 3 or, respectively, projects beyond the open secondary packaging 4 formed as the second sterilized barrier 2.The inner packaging 11, formed as the first sterile barrier 2, can now be easily removed by the nurse from the sterile operating room due to the existing protrusion, and the sterile medical product can be delivered to the attending physician after opening the inner packaging 11, formed as the first sterile barrier 2.

[0036] Fig. 4 shows a second example of a sterilized packaging configuration 1 for medical products according to the invention. Identical elements and / or components of the first configuration example in Figs. 1 to 3 are provided with the same reference signs, so that only differences between the first and second configuration examples are discussed below. In this configuration example, the sterilized packaging 1 is additionally provided with a tear tab / removal tab 10 at the predetermined rupture point 9. In addition to the predetermined rupture point 9, the tear tab / removal tab 10 serves as an additional possibility to open the sterilized packaging 1 more easily than was possible in the prior art. By pulling the tear tab / removal tab 10, the secondary packaging 4 formed as the Petition 870220054988, dated 06 / 23 / 2022, pp. 21 / 27 15 / 17 second sterilized barrier 3 can be torn / opened at the predetermined breaking point 9 without complications and without relatively much force.

[0037] Fig. 5 shows a typical structure of a secondary packaging 4 of the sterilized packaging 1 according to the present disclosure. According to the present invention, the secondary packaging 4 is configured as a composite packaging, for example, in the form of a beverage box, consisting of so-called composite materials. In Fig. 5, the composite material of the secondary packaging 4 consists of a multilayer composite made of cardboard 8, a plastic sheet 6, in particular a polyethylene sheet 6, and an aluminum sheet 7. However, the composite material of the secondary packaging 4 may alternatively also consist only of a multilayer composite made of cardboard 5 and a plastic sheet 6, in particular a polyethylene sheet 6. The individual components of the material fulfill different functions in this context. The cardboard 8 gives the shape and stability to the composite material and also provides a smooth surface for printing on the sterilized packaging 1.The plastic sheet or polyethylene sheet 6, in turn, protects the inner packaging 11 formed as the first sterilized barrier 2 and the medical product located therein from moisture and serves as an adhesive layer between the cardboard 5 and the aluminum foil 7. The aluminum foil 7, in turn, protects the medical product located in the secondary packaging 4 within the inner packaging 11 formed as the first sterilized barrier 2 from external influences, such as extreme temperatures. For an efficient combination of the individual functions of the material components, the multilayer composite may consist of two layers of polyethylene sheet 6 from the inside out, a layer of aluminum foil 7 followed by another layer of polyethylene sheet 6, a layer of paper or cardboard 8, and an outer layer of polyethylene sheet 6. Alternatively, the multilayer composite may have a different structure and may be variably designed depending on its function. Petition 870220054988, dated 06 / 23 / 2022, pp. 22-27 16 / 17

[0038] In summary, the invention relates to a sterilized packaging 1 for sterilized medical products, in particular implants, which has a first internal sterilized barrier 2 and a second external sterilized barrier 3, which is separate and independent of the first sterilized barrier 2 and which is contained in a secondary packaging 4. According to the invention, the secondary packaging 4 of such sterilized packaging 1 consists of a composite material, including a paper / cardboard 8 and at least one lining or foil, and is configured and provided to form the second sterilized barrier 3 of the sterilized packaging 1.

[0039] In summary, the invention relates to a sterilized packaging for sterilized medical products, in particular implants, which has at least one or, in the case of multiple sterilized packaging, at least one first internal sterilized barrier and a second external sterilized barrier that is separate and independent of the first sterilized barrier and which is contained in a secondary packaging. According to the invention, the secondary packaging of such sterilized packaging consists of a composite material, inter alia made of cardboard and at least one liner or foil, and is configured and provided to form the second sterilized barrier of the sterilized packaging. List of reference signs Sterilized packaging First sterilized barrier, interior Second sterilized barrier, external Secondary packaging Composite packaging Plastic sheet / polyethylene sheet Aluminum foil Paper / cardboard Predetermined breaking point Petition 870220054988, dated 06 / 23 / 2022, pp. 23 / 27 17 / 17 Tear flap / removal flap Inner packaging Petition 870220054988, dated 06 / 23 / 2022, pages 24 / 27

Claims

1 / 2 CLAIMS 1. Sterilized packaging (1) for sterilized medical products that is constructed as a double sterilized packaging with a first sterilized inner barrier (2) and a second sterilized outer barrier (3) that is separate and independent of the first sterilized barrier (2) and that is accommodated in a secondary packaging (4), characterized in that the secondary packaging (4) consists of a composite material, among others a cardboard (8) and at least one liner or foil, and the secondary packaging (4) is designed and provided to form the second sterilized outer barrier (3) of the sterilized packaging (1) and the inner packaging (11), which is designed as a first sterilized barrier (2) and in which at least one sterilized medical product is placed, protrudes when the secondary packaging (4) designed as a second sterilized barrier (3) is opened.

2. Sterilized packaging (1) for sterilized medical products according to claim 1, characterized in that a part of the secondary packaging is designed to be gas permeable.

3. Sterilized packaging (1) for sterilized medical products, according to claim 1 or 2, characterized in that the secondary packaging (4) is additionally surrounded by cellophane.

4. Sterilized packaging (1) for sterilized medical products, according to claim 1 or 3, characterized in that the composite material of the secondary packaging (4) consists of a multilayer composite of cardboard (5) and plastic sheet (6).

5. Sterilized packaging (1) for sterilized medical products, according to claim 4, characterized in that the composite material of the secondary packaging (4) consists of a multilayer composite of cardboard (8), plastic sheet (6) and aluminum foil (7).

6. Sterilized packaging (1) for sterilized medical products, according to claim 5, characterized in that the multilayer compound Petition 870220054999, dated 06 / 23 / 2022, page 8 / 9 2 / 2 consists, from the inside out, of two layers of polyethylene foil, one layer of aluminum foil (7) followed by another layer of polyethylene foil, one layer of paper / cardboard (8) and an outer layer of polyethylene foil.

7. Sterilized packaging (1) for sterilized medical products, according to any one of claims 1 to 6, characterized in that the secondary packaging (4) formed as a second sterilized barrier (3) of the sterilized packaging (1) has a predetermined breaking point (9).

8. Sterilized packaging (1) for sterilized medical products, according to claim 7, characterized in that the predetermined breaking point (9) is located in the upper third of the outer secondary packaging (4) designed as a second sterilized barrier (3) of the sterilized packaging (1).

9. Sterilized packaging (1) for sterilized medical products, according to claim 7 or 8, characterized in that the predetermined breaking point (9) is perforated.

10. Sterilized packaging (1) for sterilized medical products, according to any one of claims 1 to 9, characterized in that at least one layer of the multilayer composite of the secondary packaging material (4) is not perforated.

11. Sterilized packaging (1) for sterilized medical products, according to any one of claims 1 to 10, characterized in that, with the exception of the innermost layer of the multilayer composite of the secondary packaging material (4), all layers of the multilayer composite are perforated.

12. Sterilized packaging (1) for sterilized medical products according to claim 7, characterized in that the predetermined breaking point (9) is additionally provided with a tear tab / removal tab (10). Petition 870220054999, dated 23 / 06 / 2022, page 9 / 9

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