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  6. Biological safety testing of medical devices

Biological safety testing of medical devices

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last updated:Jul 24, 2025

SRD生物センター
SRD生物センター
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In addition to GLP testing, we can also accommodate screening tests for raw materials (non-GLP).

At a testing facility that has been continuously certified as a medical device GLP-compliant facility for approximately 18 years, we are able to conduct tests in accordance with the international standard ISO 10993. Additionally, we accept screening tests aimed at preliminary assessments of safety in the development of medical device raw materials. Based on the achievements and knowledge accumulated over more than half a century, we not only deliver reliable and high-quality data but also provide suggestions for testing methods and extraction methods tailored to the characteristics of the test samples before the tests are conducted.

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Biological safety testing of medical devices

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■Medical Devices - Cytotoxicity Test - Skin Sensitization Test - Irritation/Intradermal Reactivity Test - Acute Systemic Toxicity Test - Genotoxicity Test (Ames/Chromosomal Aberration/Micronucleus) - Pyrogen Test - Endotoxin Test - Hemocompatibility Test (Hemolytic) - Extraction Rate Confirmation Test

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SRD生物センター

SRD生物センター

Testing, Analysis and Measurement

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Our company was established in 1971 as the Japan Experimental Medicine Research Institute, and in 2003, when we became a member of the SRD Group, we changed our name to SRD Bio Center Co., Ltd. Since then, we have been dedicated to safety testing for pharmaceuticals, medical devices, pesticides, and chemicals. During this time, the environment surrounding us has changed significantly with the domestic introduction of OECD test guidelines, the application of GLP, the establishment of ICH, the revision of the Animal Welfare Act leading to a reduction in the use of laboratory animals and a shift to alternative methods, as well as the globalization of the development and manufacturing of pharmaceuticals, medical devices, pesticides, and chemicals. In such an environment, we take pride in leveraging our many years of experience to swiftly capture technological innovations and regulatory changes, continuously acquiring new information to provide highly reliable services.

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