SSCP

Brainlab III 类医疗设备的安全性和临床性能摘要 (SSCP) 旨在向预期用户直接提供有关医疗设备安全性和临床性能的信息。SSCP 提供临床评估摘要、适应症和禁忌症信息以及与该设备相关的警告和风险。此外，它还包含有关上市后监督工作以及上市后临床随访的信息，且每年更新一次。

SSCP 不用于对特定医疗条件的诊断或治疗提供一般性建议；也不作为确保设备安全使用的主要文件取代使用说明，或取代任何其他强制性文件。

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