[Fukuda Pin Hole for Medical Devices (Pseudo Defect / Reference Test Piece)]
Pinhole, pseudo-defect, reference specimen, positive control, defective product sample, standard setting, validity evaluation, JP18, packaging integrity evaluation.
For the evaluation of joints in medical devices. Pseudo-defects/reference test pieces with specified hole diameter and hole length.
In the medical device industry, evaluating the airtightness of joints is crucial to ensure product safety and reliability. Particularly in medical devices that are implanted in the body or in devices that handle pharmaceutical liquids, leaks at the joints can lead to serious issues. Our Fukuda Pinhole (pseudo-defect/reference test piece) is useful for standard setting and validity assessment in joint leakage testing. By using it as a positive control (defective sample), more accurate evaluations can be achieved. 【Application Scenarios】 - Evaluation of the airtightness of joints in medical devices - Leakage testing of pharmaceutical containers - Assessment of packaging integrity in accordance with JP18 【Benefits of Implementation】 - Reduced risk of joint leakage - Improved product quality - Assurance of compliance with standards
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【Features】 - Pseudo-defects with specified hole diameter and length (reference test piece) - Compatible with pressure change leak testing method and liquid immersion testing method - Usable for evaluating packaging integrity in accordance with JP18 - Material: SUS 304, Ni - Hole diameters: Φ5, 10, 15, 20, 50, 100, and others 【Our Strengths】 With 60 years of pursuit in leak detection, we are advancing the future of leak testing. We offer optimal leak testers tailored to meet various leak testing needs of our customers. Certified under JIS Q 9001:2015 (ISO 9001:2015).
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Applications/Examples of results
- Evaluation of packaging integrity in accordance with JP18 - Setting of "maximum allowable leakage limit" - Testing for the intrusion of water vapor, oxygen, and microorganisms - Quantification from qualitative testing methods (current leakage standards converted to pore size)
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【 Various Leak Testing Solutions: Air Leak Test / Gas Leak Test (Hydrogen Gas, Helium Gas) 】 We develop, manufacture, and sell leak testing equipment to inspect airtightness and sealing performance. We will propose appropriate testers and devices for each inspection target. 【 Target Industries and Examples of Inspection Targets 】 - Automotive Industry: Engines, FC components, valves and piping, various parts - Electronic Components Industry: Smartphones, keyless switches, various small sensors - Pharmaceuticals / Food / Cosmetics Industry: Bottle containers, syringes, vials, eye drop containers, pillow packaging, PTP packaging We will propose the "optimal leak tester" for each industry. 【 ISO Certification 】JIS Q 9001:2015 (ISO 9001:2015) Head Office Address: 3-16-5 Nukui, Nerima-ku, Tokyo (Postal Code: 176-0021) Phone Number: 03-3577-1111 (Main)






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