Inspection device for blood preparation, inspection method, and program

Abstract

SOLUTION: An inspection device 14 of a blood preparation P comprises: a color tone acquisition unit 30 for acquiring color tone data 46 on the basis of imaging data 20 obtained by imaging a blood bag BG in which the blood preparation P is stored; a hue determination unit 32 for determining whether a hue of the blood preparation P is in an allowable range, on the basis of the color tone data 46 and reference color tone data 483 of a blood bag BG in which no blood preparation P is stored; and a specification determination unit 40 for determining that the blood preparation P in the blood bag BG does not conform to a standard, if the hue is out of the allowable range.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present invention relates to an inspection device for inspecting blood products, a computer-executable method for inspecting blood products, and a program for causing a computer to execute the inspection method. [Background technology]

[0002] Patent Document 1 discloses a blood bag system. The blood bag system has a plurality of blood bags. Each of the plurality of blood bags stores a blood component (blood product). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2016-106012 A Summary of the Invention [Problem to be solved by the invention]

[0004] One of the inspections to ensure the quality of blood products is visual inspection. In visual inspection, an inspector visually checks the blood product inside the blood bag. However, visual inspection has the problem that it places a heavy burden on the inspector.

[0005] The present invention aims to solve the above-mentioned problems. [Means for solving the problem]

[0006] A first aspect of the present invention is a blood product inspection device comprising: a color acquisition unit that acquires color data of the blood bag including the blood product based on imaging data of the blood bag containing the blood product; a color judgment unit that determines whether the color of the blood product is within an acceptable range based on a comparison of the color data with reference color data of the blood bag without the blood product; and a standard judgment unit that determines that the blood product in the blood bag does not comply with standards if the color is outside the acceptable range.

[0007] A second aspect of the present invention is an inspection method in which a computer inspects a blood product contained in a blood bag, the inspection method including: a color acquisition step of acquiring color data of the blood bag including the blood product based on imaging data of the blood bag; a color determination step of determining whether the color of the blood product is within an acceptable range based on comparison of the color data with reference color data of the blood bag in a state in which the blood product is not contained; and a standard determination step of determining that the blood product in the blood bag does not comply with standards if the color is outside the acceptable range.

[0008] A third aspect of the present invention is a program for causing a computer to execute the inspection method according to the second aspect. Effect of the Invention

[0009] According to the present invention, the burden on inspectors is reduced. [Brief description of the drawings]

[0010] [Figure 1] FIG. 1 is a configuration diagram of an inspection system according to an embodiment. [Diagram 2] FIG. 2 is a configuration diagram of the inspection device. [Diagram 3] FIG. 3 is a flowchart illustrating the flow of a blood product testing method according to an embodiment. [Figure 4] FIG. 4 is a configuration diagram of an inspection system according to the first modification. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] [Embodiment] FIG. 1 is a configuration diagram of an inspection system 10 according to an embodiment.

[0012] The inspection system 10 is a system that inspects the appearance of a blood product P made from blood collected from a donor. The inspection system 10 is installed in, for example, a blood center. The blood product P is contained in a plurality of blood bags BG. An appearance inspection of the blood product P is performed for each blood bag BG containing the blood product P.

[0013] The inspection system 10 includes an imaging device 12, an inspection device (instrument for inspecting a blood product P) 14, and a display device 16.

[0014] The imaging device 12 is, for example, a camera. The imaging device 12 captures an image of the blood bag BG containing the blood product P.

[0015] In order for the imaging device 12 to image the blood bag BG, an inspector (operator) sets the blood bag BG in a predetermined set position in advance. The imaging device 12 images the blood bag BG set in the predetermined set position according to the instructions of the inspector. The predetermined set position is, for example, a suspension stand 18 from which the blood bag BG can be suspended. Note that a plurality of blood bags BG may be suspended from one suspension stand 18.

[0016] The imaging device 12 outputs imaging data 20 of the captured blood bag BG to the inspection device 14 (see also FIG. 2).

[0017] The display device 16 is a display device controlled by the inspection device 14. The display device 16 has a display screen 161. The display screen 161 is, for example, a liquid crystal screen.

[0018] FIG. 2 is a diagram showing the configuration of the inspection device 14.

[0019] The inspection device 14 is a computer that performs an appearance inspection of the blood bag BG (blood product P in the blood bag BG) based on the input imaging data 20. The inspection device 14 may be included in a server device that manages the blood center. The inspection device 14 includes a memory unit 22 and a calculation unit 24.

[0020] The storage unit 22 includes a storage circuit, which includes one or more memories such as a random access memory (RAM) or a read only memory (ROM).

[0021] The storage unit 22 stores the appearance inspection program 26 and the bag reference data 48. The appearance inspection program 26 is a program for causing the inspection device 14 to execute the inspection method for the blood product P according to this embodiment. The bag reference data 48 is data (data group) related to the corresponding blood bag BG. For example, the bag reference data 48 includes a manufacturer 481, shape information 482, and reference color data 483. The manufacturer 481 indicates the manufacturer that manufactured the blood bag BG. The shape information 482 indicates the shape, size, etc. of the blood bag BG in a state in which the blood product P is not contained. The reference color data 483 indicates the reference color, which is the color tone of the blood bag BG in a state in which the blood product P is not contained. The storage unit 22 may store a plurality of bag reference data 48 having different combinations of the manufacturer 481, the shape information 482, the reference color data 483, etc.

[0022] The data stored in the storage unit 22 is not limited to the appearance inspection program 26. The storage unit 22 may store various types of data as necessary.

[0023] The calculation unit 24 includes a processing circuit. The processing circuit includes, for example, one or more processors. However, the processing circuit of the calculation unit 24 may include an integrated circuit such as an ASIC (Application Specific Integrated Circuit) or an FPGA (Field-Programmable Gate Array). The processing circuit of the calculation unit 24 may also include a discrete device.

[0024] The calculation unit 24 includes an imaging data acquisition unit 28, a reference data determination unit 29, a color tone acquisition unit 30, a color judgment unit 32, a binarization processing unit 34, a foreign matter judgment unit 36, a shaking judgment unit 38, a standard judgment unit 40, and a display control unit 42.

[0025] The imaging data acquisition unit 28, the reference data determination unit 29, the color tone acquisition unit 30, the color judgment unit 32, the binarization processing unit 34, the foreign matter judgment unit 36, the shaking judgment unit 38, the standard judgment unit 40, and the display control unit 42 are realized by the processor of the calculation unit 24 executing the appearance inspection program 26. However, at least a part of the imaging data acquisition unit 28, the reference data determination unit 29, the color tone acquisition unit 30, the color judgment unit 32, the binarization processing unit 34, the foreign matter judgment unit 36, the shaking judgment unit 38, the standard judgment unit 40, and the display control unit 42 may be realized by the above-mentioned integrated circuits, discrete devices, etc.

[0026] The imaging data acquisition unit 28 stores the imaging data 20 input from the imaging device 12 in the storage unit 22. Incidentally, a plurality of pieces of imaging data 20 corresponding to each of a plurality of blood bags BG are input to the inspection device 14. Therefore, the imaging data acquisition unit 28 stores the plurality of pieces of imaging data 20 in the storage unit 22. However, the imaging data acquisition unit 28 stores each of the plurality of pieces of imaging data 20 in the storage unit 22 in association with the identification information 44 of the corresponding blood bag BG.

[0027] The identification information 44 includes, for example, an identification number previously assigned to each of the blood bags BG, and information for identifying the bag reference data 48 corresponding to each blood bag BG. The information for identifying the bag reference data 48 includes, for example, the manufacturer of the blood bag BG.

[0028] The identification information 44 is indicated, for example, by a barcode attached in advance to each blood bag BG. In this case, the identification information 44 of each blood bag BG brought into the blood center is read by a barcode reading device (barcode reader) and stored in the memory unit 22.

[0029] An electronic tag that stores the identification information 44 by RFID (Radio Frequency Identifier) ​​may be attached to each blood bag BG in advance. In this case, the identification information 44 of each blood bag BG brought into the blood center is read by a reader for electronic tags (RFID reader) and stored in the memory unit 22.

[0030] The reference data determination unit 29 determines the bag reference data 48 corresponding to the blood bag BG based on the identification information 44 of the blood bag BG. For example, as described above, the identification information 44 includes the manufacturer of the blood bag BG. The reference data determination unit 29 compares the manufacturer indicated by the identification information 44 with the manufacturer 481 of each of the multiple bag reference data 48. The reference data determination unit 29 determines the bag reference data 48 including the same manufacturer 481 as the manufacturer indicated by the identification information 44 as the bag reference data 48 corresponding to the blood bag BG.

[0031] The color tone acquisition unit 30 acquires color tone data 46 of the blood bag BG shown in the imaging data 20 based on the imaging data 20. The acquired color tone data 46 indicates the color tone of the blood bag BG including the blood product P in the blood bag BG.

[0032] Here, the color tone acquiring section 30 may refer to the shape information 482 of the bag reference data 48 corresponding to the blood bag BG. This allows the color tone acquiring section 30 to acquire the shape, size, etc. of the blood bag BG. The color tone acquiring section 30 may recognize an acquisition range for acquiring the color tone data 46 of the blood bag BG from within the imaging data 20, based on the shape, size, etc. of the blood bag BG. This allows the color tone acquiring section 30 to more accurately acquire the color tone data 46 of the blood bag BG based on the acquisition range.

[0033] The color tone acquiring unit 30 acquires color tone data 46 of each of the plurality of blood bags BG. The color tone acquiring unit 30 stores the acquired plurality of color tone data 46 in the storage unit 22. However, the color tone acquiring unit 30 stores each of the plurality of color tone data 46 in the storage unit 22 in association with the identification information 44 of the corresponding blood bag BG.

[0034] The color judgment unit 32 judges whether the color of the blood product P in the blood bag BG is within an acceptable range based on a comparison between the color data 46 and the reference color data 483 of the blood bag BG corresponding to the color data 46.

[0035] The acceptable range indicates a range of colors that comply with the standards for the blood product P. The acceptable range is stored in advance in the memory unit 22. There are multiple types of blood product P, such as red blood cell products, plasma products, and platelet products. Therefore, the memory unit 22 may store multiple acceptable ranges according to the types of blood product P.

[0036] The storage unit 22 may also store in advance a correspondence between the identification information 44 of the blood bag BG and the type of blood product P in the blood bag BG. This allows the color judgment unit 32 to automatically use the allowable ranges corresponding to the blood product P in each blood bag BG based on the correspondence.

[0037] The reference color tone may differ for each blood bag BG depending on, for example, the manufacturer of the blood bag BG. By comparing the color tone data 46 of each bag with the reference color tone data 483, the color tone of the blood product P in the blood bag BG can be accurately extracted based on the difference between the color tone data 46 and the reference color tone data 483. This allows the color judgment unit 32 to accurately inspect the color tone of the blood product P in each blood bag BG at a constant level, regardless of the difference in the reference color tone of each blood bag BG.

[0038] The binarization processing unit 34 binarizes the imaging data 20 to generate binary image data 50 corresponding to the imaging data 20. The binarization processing unit 34 stores the generated binary image data 50 in the storage unit 22 in association with the identification information 44 of the corresponding blood bag BG.

[0039] The threshold value required for the binarization process is stored in advance in the storage unit 22. As with the above-mentioned allowable range, the storage unit 22 may store a plurality of threshold values ​​according to the type of blood product P. The threshold value is determined so that the blood product P (blood bag BG containing the blood product P) and other portions of the imaging data 20 are shown in different colors in the binary image data 50.

[0040] As a result, the blood product P (the blood bag BG containing the blood product P) is represented, for example, in white in the binary image data 50. In contrast, in the binary image data 50, the foreign matter is represented, for example, in black.

[0041] The foreign matter determination unit 36 ​​determines whether or not a foreign matter is present in the blood bag BG based on the imaging data 20 corresponding to the blood bag BG. Here, the foreign matter determination unit 36 ​​refers to binary image data 50 created based on the imaging data 20.

[0042] As described above, the portion of the binary image data 50 that contains a foreign object is displayed in a color different from that of the blood product P. Based on the binary image data 50, the foreign object determination unit 36 ​​can accurately determine whether or not a foreign object is present in the blood bag BG.

[0043] The foreign substance determination unit 36 ​​may refer to the shape information 482 of the bag reference data 48 corresponding to the blood bag BG. This allows the foreign substance determination unit 36 ​​to acquire the shape, size, etc. of the blood bag BG. The foreign substance determination unit 36 ​​may recognize a determination range in the binary image data 50 for determining the presence or absence of a foreign substance based on the shape, size, etc. of the blood bag BG. This allows the foreign substance determination unit 36 ​​to more accurately acquire the presence or absence of a foreign substance based on the determination range. However, the foreign substance determination unit 36 ​​may also recognize the determination range based on the acquisition range recognized by the color tone acquisition unit 30.

[0044] If the color of the blood product P is outside the allowable range, the blood product P is non-compliant with the standard regardless of whether or not a foreign matter is mixed in. Therefore, it is preferable that the blood bags BG to be judged as to whether or not a foreign matter is mixed in are limited to blood bags BG containing blood products P whose color is judged to be within the allowable range. This improves the time efficiency of the appearance inspection performed by the inspection device 14.

[0045] The foreign matter determination unit 36 ​​determines whether or not a foreign matter has been mixed into the blood bag BG. However, the foreign matter in the blood bag BG may be removed from the blood bag BG by subjecting the blood bag BG to a shaking process.

[0046] For example, when the blood product P is a platelet product, platelets may aggregate within the blood bag BG. A clump of aggregated platelets (clump) is represented as a foreign body in the binary image data 50 described above. However, this clump will disperse within the blood bag BG if the blood bag BG is subjected to a shaking process for a predetermined time or more. In other words, the clump of aggregated platelets will disappear from within the blood bag BG if it is shaken for a predetermined time or more. The predetermined time is, for example, 24 hours.

[0047] In view of the above, when it is determined that a foreign object is mixed in the blood bag BG, the shaking determination unit 38 determines whether or not the blood bag BG has already been subjected to a shaking process for a predetermined time or more based on the shaking process execution history 52. ​​The shaking process execution history 52 is stored in the storage unit 22.

[0048] The standard determination unit 40 determines whether or not the blood product P in the blood bag BG is non-compliant with the standard, based on the respective determination results of the color determination unit 32, the foreign matter determination unit 36, and the shaking determination unit 38. The standard determination unit 40 determines whether or not the blood product P is non-compliant with the standard, based on the following determination criteria (1) to (3).

[0049] (1) Blood product P, whose color is outside the acceptable range, is non-compliant.

[0050] (2) Blood product P that has been contaminated with foreign matter and is contained in blood bag BG after being shaken for a specified period of time or more is non-compliant with the standard even if the color is within the acceptable range.

[0051] (3) A blood product P that is contaminated with a foreign matter and is contained in a blood bag BG that has not yet been shaken for a predetermined time or more is subject to a shaking process for a predetermined time or more. In other words, a blood product P that is contaminated with a foreign matter and is contained in a blood bag BG that has not yet been shaken for a predetermined time or more may be made to comply with the standard by subjecting the blood bag BG to a shaking process for at least a predetermined time.

[0052] The standard determination unit 40 may store the determination result of the blood product P in the memory unit 22 in association with the corresponding blood bag BG (identification information 44).

[0053] When the blood product P in the blood bag BG falls under the above (1) or (2), the display control unit 42 causes the display screen 161 of the display device 16 to display a message indicating that the blood product P does not comply with the standard. This notifies the inspector of the inspection result. If the standard determination unit 40 determines that the blood product P falls under the above (3), the display control unit 42 may control the display device 16 to display a message on the display screen 161 urging the inspector to subject the blood bag BG to a shaking process for a predetermined period of time.

[0054] When the blood product P in the blood bag BG corresponds to the above (3), the display control unit 42 displays on the display screen 161 that the blood product P may be made to comply with the standard by subjecting the blood bag BG to a shaking process for at least a predetermined time. This reduces the risk of the blood product P being discarded.

[0055] In addition, blood products P in blood bags BG that fall under (2) above may be able to comply with the standard if the color is within the acceptable range and an inspector removes foreign matter from the blood bag BG using a syringe or other device.

[0056] In light of this, it is more preferable that when the reason why the blood product P does not comply with the standard is (2) above, the display control unit 42 displays on the display screen 161 that there is a possibility that the blood product P may comply with the standard by removing the foreign matter from the blood bag BG.

[0057] This allows the inspector to notice blood products P that are determined to be non-compliant due to the presence of foreign matter in the blood bag BG even though the color is within the acceptable range. In other words, the risk of the blood products P being discarded can be further reduced.

[0058] FIG. 3 is a flowchart illustrating the flow of the method for testing a blood product P according to the embodiment.

[0059] The inspection device 14 can execute the inspection method exemplified in Fig. 3. This inspection method includes an imaging data acquisition step S1, a reference data determination step S2, a color tone acquisition step S3, a color judgment step S4, a binarization processing step S5, a foreign matter judgment step S6, a shaking judgment step S7, and a standard judgment step S8. The standard judgment step S8 includes a first conclusion step (compliance with standard) S81, a second conclusion step (suggestion for shaking processing) S82, and a third conclusion step (non-compliance with standard) S83.

[0060] In the imaging data acquisition step S 1 , the imaging data acquisition unit 28 acquires the imaging data 20 .

[0061] In the reference data determination step S2, the reference data determination unit 29 determines the bag reference data 48 corresponding to the imaging data 20. That is, in the reference data determination step S2, the reference data determination unit 29 determines the bag reference data 48 corresponding to the imaged blood bag BG.

[0062] In the color tone acquisition step S3, the color tone acquisition unit 30 acquires color tone data 46 based on the imaging data 20. The color tone data 46 indicates the color tone of the blood bag BG including the blood product P in the blood bag BG.

[0063] In the color determination step S4, the color determination unit 32 determines whether the color of the blood product P in the blood bag BG is within an acceptable range. The color determination unit 32 can accurately determine whether the color of the blood product P is within an acceptable range based on a comparison between the color data 46 acquired in the color acquisition step S3 and the reference color data 483 stored in the memory unit 22.

[0064] If the color of the blood product P in the blood bag BG is within the allowable range, the binarization step S5 and the foreign matter determination step S6 are performed in sequence. If the color of the blood product P in the blood bag BG is outside the allowable range, the third conclusion step S83 of the standard determination step S8 is performed.

[0065] In the binarization step S5, the binarization processor 34 creates binary image data 50 based on the captured image data 20. In the binary image data 50, the blood product P and the foreign matter are represented in different colors.

[0066] In the foreign matter determination step S6, the foreign matter determination unit 36 ​​determines whether or not a foreign matter has been mixed into the blood bag BG, based on the binary image data 50 created based on the imaging data 20.

[0067] If it is determined that the blood bag BG contains a foreign object, the shaking determination step S7 is performed. If it is determined that the blood bag BG does not contain a foreign object, the first conclusion step S81 of the standard determination step S8 is performed.

[0068] In the shaking determination step S7, the shaking determination unit 38 refers to the execution history 52 of the shaking process stored in the memory unit 22 to determine whether or not the blood bag BG has already been subjected to a shaking process for a predetermined period of time or more.

[0069] If the blood bag BG has already been shaken for a predetermined time or more, the third conclusion step S83 of the standard determination step S8 is performed. If the blood bag BG has not yet been shaken for a predetermined time or more, the second conclusion step S82 of the standard determination step S8 is performed.

[0070] In the first conclusion step S81 of the standard determination step S8, the standard determination unit 40 determines that the blood product P in the blood bag BG complies with the standard. The display control unit 42 displays the result of this determination on the display screen 161.

[0071] In the second conclusion step S82, the standard determination unit 40 determines that there is a possibility that foreign matter can be removed from the blood bag BG by subjecting the blood bag BG to a shaking process for at least a predetermined time. Based on this determination result, the display control unit 42 causes the display screen 161 to display, for example, a message suggesting that the blood bag BG be shaken.

[0072] In the third conclusion step S83 of the standard determination step S8, the standard determination unit 40 determines that the blood product P in the blood bag BG does not comply with the standard. This determination result is displayed on the display screen 161 by the display control unit 42, similar to the determination result of the standard determination step S8.

[0073] Here, it is preferable that the display control unit 42 further displays a message proposing to remove the foreign matter from the blood bag BG corresponding to the above-mentioned (2) on the display screen 161. This can reduce the risk of the blood product P being discarded.

[0074] The blood bag BG corresponding to the above-mentioned (2) is a blood bag BG for which the result of the color judgment step S4 is YES (color is within the allowable range) and the result of the shaking judgment step S7 is YES (shaken for a predetermined time or longer).

[0075] Completion of the standard determination step S8 ends the visual inspection of one blood bag BG. According to this embodiment, the inspection device 14 performs visual inspection of the blood product P contained in the blood bag BG with a certain level of accuracy. This reduces the workload of the inspector.

[0076] [Variations] Modifications of the above embodiment are described below. However, descriptions that overlap with the above embodiment are omitted as much as possible in the following description. Components that have already been described in the above embodiment are given the same reference numerals as in the above embodiment unless otherwise specified.

[0077] (Variation 1) FIG. 4 is a configuration diagram of an inspection system 101(10) according to the first modification.

[0078] The number of each of the imaging devices 12 and the display devices 16 is not limited to one. For example, the inspection system 101 includes a single inspection device 14, a plurality of imaging devices 12, and a plurality of display devices 16. Imaging data 20 is input to the inspection device 14 from each of the plurality of imaging devices 12. The inspection device 14 performs an appearance inspection of a plurality of blood bags BG based on each imaging data 20.

[0079] The results of the appearance inspection performed by the inspection device 14 based on each piece of captured image data 20 (the judgment results of the standard judgment section 40) are displayed on the display screens 161 of the multiple display devices 16 as necessary.

[0080] (Variation 2) The inspection system 10 may further include an operating device for setting the blood bag BG at a predetermined set position. In this case, an inspector does not need to set the blood bag BG at the predetermined set position. The operating device is, for example, a robot equipped with an arm for holding the blood bag BG.

[0081] In addition, the imaging device 12 may automatically capture an image of the set blood bag BG in conjunction with the operation device setting the blood bag BG at a predetermined set position. In this case, the examiner does not need to instruct the imaging device 12 to capture an image.

[0082] (Variation 3) At least a part of the storage unit 22 may be realized by an external storage device installed in a location separate from the inspection device 14. In this case, the inspection device 14 and the external storage device are connected to be able to communicate with each other via a network.

[0083] (Variation 4) The inspection system 10 may further include a transport robot that transports a plurality of blood bags BG. The inspection device 14 may instruct the transport robot to transport the blood bag BG corresponding to the above (3) to, for example, a shaking device that shakes and stores the blood bag BG. This further reduces the workload of the inspector.

[0084] (Variation 5) The display control unit 42 may appropriately display not only the determination result of the standard determination unit 40 but also various other data on the display screen 161. For example, the display control unit 42 may display the imaging data 20, the color tone data 46, the binary image data 50, and the like acquired by the inspection device 14 on the display screen 161.

[0085] (Combination of multiple modifications) The above-described multiple modified examples may be combined as appropriate within a range that does not contradict each other.

[0086] [Inventions Obtained from the Embodiments] The invention that can be understood from the above-described embodiment and modifications will be described below.

[0087] <First invention> The first invention is a blood product inspection device (14) comprising: a color acquisition unit (30) that acquires color data (46) of the blood bag (BG) containing a blood product (P) based on imaging data (20) of the blood bag (BG) containing the blood product; a color determination unit (32) that determines whether the color of the blood product is within an acceptable range based on a comparison of the color data with reference color data (483) of the blood bag in a state in which the blood product is not contained; and a standard determination unit (40) that determines that the blood product in the blood bag does not comply with standards if the color is outside the acceptable range.

[0088] This reduces the burden on inspectors.

[0089] The color tone acquisition unit may recognize an acquisition range for acquiring the color tone data from the imaging data based on shape information (482) of the captured blood bag, thereby acquiring the color tone data more accurately.

[0090] The first invention further includes a storage unit (22) for storing bag reference data (48) including the shape information and a manufacturer (481) for each of the blood bags, and a reference data determination unit (29) for determining the bag reference data corresponding to the imaged blood bag based on the manufacturer of the imaged blood bag, and the color tone acquisition unit may recognize the acquisition range based on the shape information of the bag reference data determined by the reference data determination unit. This allows the color tone data to be acquired more accurately.

[0091] The first invention may further include a foreign matter determining unit (36) that determines whether or not a foreign matter is present in the blood bag based on the imaging data when the color is within the allowable range, thereby improving the time efficiency of the appearance inspection.

[0092] The foreign matter determination unit may determine whether or not the blood bag contains a foreign matter based on binary image data (50) obtained by binarizing the captured image data. This makes it possible to accurately determine whether or not the blood bag contains a foreign matter.

[0093] The first invention further includes a shaking determination unit (38) that, when it is determined that the blood bag contains the foreign matter, determines whether or not the blood bag containing the foreign matter has already been subjected to a shaking process for a predetermined time or more based on the execution history (52) of the shaking process, and the standard determination unit may determine that the blood product in the blood bag containing the foreign matter and shaken for the predetermined time or more is non-compliant. This makes it possible to reduce blood products that are determined to be non-compliant due to the presence of foreign matter.

[0094] The standard determination unit may determine that the blood bag that is determined to contain the foreign matter and that has not been shaken for the predetermined time or longer is to be subjected to the shaking process, thereby further reducing blood products that are determined to be non-compliant due to the presence of foreign matter.

[0095] <Second Invention> The second invention is an inspection method for inspecting a blood product (P) contained in a blood bag (BG) by a computer, comprising: a color acquisition step (S3) for acquiring color data (46) of the blood bag including the blood product based on imaging data (20) of the blood bag; a color determination step (S4) for determining whether or not the color of the blood product is within an acceptable range based on a comparison of the color data with reference color data (483) of the blood bag in a state in which the blood product is not contained; and a standard determination step (S8) for determining that the blood product in the blood bag does not comply with the standard if the color is outside the acceptable range.

[0096] This reduces the burden on inspectors.

[0097] In the color tone acquisition step, the computer may recognize an acquisition range from which the color tone data is acquired from the imaging data based on shape information (482) of the captured blood bag, thereby acquiring the color tone data more accurately.

[0098] The computer includes a storage unit (22) for storing bag reference data (48) including the shape information and a manufacturer (481) for each of the blood bags, and the inspection method further includes a reference data determination step (S2) for determining the bag reference data corresponding to the imaged blood bag based on the manufacturer of the imaged blood bag, and the color tone acquisition step may recognize the acquisition range based on the shape information of the bag reference data determined in the reference data determination step. This allows the color tone data to be acquired more accurately.

[0099] The second invention may further include a foreign matter determination step (S6) of determining whether or not a foreign matter is present in the blood bag based on the imaging data when the color is within the allowable range, thereby improving the time efficiency of the appearance inspection.

[0100] In the foreign matter determination step, it may be determined whether or not the blood bag contains a foreign matter based on binary image data (50) obtained by binarizing the captured image data. This makes it possible to accurately determine whether or not the blood bag contains a foreign matter.

[0101] The second invention further includes a shaking determination step (S7) for determining whether or not the blood bag containing the foreign matter has been subjected to a shaking process for a predetermined time or more when the blood bag is determined to contain the foreign matter, based on the execution history (52) of the shaking process, and in the standard determination step, the blood product in the blood bag containing the foreign matter and shaken for the predetermined time or more may be determined to be non-compliant. This makes it possible to reduce blood products that are determined to be non-compliant due to the presence of foreign matter.

[0102] In the standard determination step, the blood bag that is determined to contain the foreign matter and has not been shaken for the predetermined time or longer may be determined to be a target for the shaking process, thereby further reducing blood products that are determined to be non-compliant due to the presence of foreign matter.

[0103] <Third Invention> A third invention is a program (26) for causing the computer to execute the inspection method according to the second invention.

[0104] This reduces the burden on inspectors. [Explanation of symbols]

[0105] 12...imaging device 14...inspection device 20: Imaging data 22: Storage unit 26... Visual inspection program 29... Reference data determination section 30: Color tone acquisition unit 32: Color judgment unit 36: Foreign matter detection section 38: Shaking detection section 40...Standards Judgment Section 46...Color Tone Data 48...Bag reference data 50...Binary image data 52...Execution history 481...Manufacturer 482...Shape information 483...Reference color data BG: Blood bag P: Blood product

Claims

1. a color tone acquiring unit that acquires color tone data of the blood bag including the blood product based on imaging data of the blood bag containing the blood product; a color determining unit that determines whether or not the color of the blood product is within an acceptable range based on a comparison between the color data and reference color data of the blood bag in a state in which the blood product is not contained; a standard determination unit that determines that the blood product in the blood bag does not comply with the standard when the color is outside the acceptable range; A blood product testing device comprising:

2. The blood product testing device according to claim 1, The color tone acquisition unit recognizes an acquisition range from which the color tone data is acquired out of the imaging data based on shape information of the captured blood bag.

3. The blood product inspection device according to claim 2, a storage unit that stores bag reference data including the shape information and a manufacturer for each of the plurality of blood bags; a reference data determination unit that determines the bag reference data corresponding to the imaged blood bag based on a manufacturer of the imaged blood bag; Further equipped with A blood product testing device, wherein the color tone acquisition unit recognizes the acquisition range based on the shape information of the bag reference data determined by the reference data determination unit.

4. The blood product inspection device according to any one of claims 1 to 3, The blood product inspection device further includes a foreign matter determination unit that determines whether or not a foreign matter has been mixed into the blood bag based on the imaging data when the color is within the acceptable range.

5. The blood product inspection device according to claim 4, The foreign matter determination unit determines whether or not the foreign matter is present in the blood bag based on binary image data obtained by binarizing the captured image data.

6. The blood product inspection device according to claim 4 or 5, The blood bag may further include a shaking determination unit that, when it is determined that the blood bag contains the foreign matter, determines whether or not a shaking process for a predetermined period of time or more has already been performed on the blood bag that is determined to contain the foreign matter, based on an execution history of the shaking process; The standard determination unit determines that the blood product in the blood bag that is determined to contain foreign matter and has been shaken for the specified time or longer is non-compliant with the standard.

7. The blood product inspection device according to claim 6, The standard determination unit determines that the blood bag that is determined to contain foreign matter and has not been shaken for the specified period of time or longer is one that requires shaking.

8. A method for inspecting a blood product contained in a blood bag by a computer, comprising: a color tone acquiring step of acquiring color tone data of the blood bag including the blood product based on imaging data of the blood bag; a color determination step of determining whether or not the color of the blood product is within an acceptable range based on a comparison between the color data and reference color data of the blood bag in a state in which the blood product is not contained; a standard determination step of determining that the blood product in the blood bag is non-compliant if the color is outside the acceptable range; 4. A method for testing comprising:

9. 9. The inspection method according to claim 8, The color tone acquiring step includes the step of: recognizing an acquisition range from which the color tone data is acquired, out of the imaging data, based on shape information of the imaged blood bag.

10. The inspection method according to claim 9, The computer includes a storage unit that stores bag reference data including the shape information and a manufacturer for each of the plurality of blood bags, The inspection method further includes a reference data determination step of determining the bag reference data corresponding to the imaged blood bag based on a manufacturer of the imaged blood bag; An inspection method, wherein in the color tone acquisition step, the acquisition range is recognized based on the shape information of the bag reference data determined in the reference data determination step.

11. The inspection method according to any one of claims 8 to 10, The inspection method further includes a foreign matter determining step of determining whether or not a foreign matter is present in the blood bag based on the imaging data when the color is within the acceptable range.

12. The inspection method according to claim 11, In the foreign matter determining step, it is determined whether or not the foreign matter is present in the blood bag based on binary image data obtained by binarizing the captured image data.

13. The inspection method according to claim 11 or 12, The method further includes a shaking determination step of, when it is determined that the blood bag contains the foreign matter, determining whether or not a shaking process for a predetermined period of time or more has already been performed on the blood bag containing the foreign matter based on an execution history of the shaking process; In the standard determination step, the blood product in the blood bag that has been determined to contain foreign matter and has been shaken for the specified time or longer is determined to be non-compliant with the standard.

14. The inspection method according to claim 13, In the standard determination step, the blood bag that is determined to contain the foreign matter and has not been shaken for the predetermined period of time or longer is determined to be subject to the shaking process.

15. A program causing the computer to execute the inspection method according to any one of claims 8 to 14.

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