Unique Skill ID: KS125D66MQ8FRGG63NVJ

ISO 10993 Standard

The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. For the purpose of the ISO 10993 family of standards, biocompatibility is defined as the "ability of a medical device or material to perform with an appropriate host response in a specific application".

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Combination Products
In Vitro Diagnostics
Medical Devices
Process Validation
Qualification Protocols (IQ/OQ/PQ)
Quality By Design (QbD)
Sterilization Validation
Test Method
Validation Protocols

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