General information

Valid from 04.08.2026

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This standard aims to measure tissue reaction, assess local biocompatibility risks, and confirm safe use for medical devices. It is used to describe in detail how tests should be performed for both subcutaneous (under the skin) and intramuscular applications. The standard is applicable to the below medical devices: Orthopedic implants (plates, screws, prostheses) Cardiovascular Devices (Stents, artificial heart valves) Dental implants Wound closure Materials (sutures, biomaterials) Medical Materials with Long-Term contact