Pryce T
SF Medical Ltd., Woodsbots Meadow, Watford, UK.
Med Device Technol. 1996 Mar;7(2):22-6, 28.
Now that CE-marking of medical devices is in force, device manufacturers need to be able to document that they employ the correct materials and components for a particular application. To do this they need to understand exactly what they are purchasing and show that their suppliers possess the necessary product range, technical expertise, and, most importantly, the quality procedures required to assure product integrity. This article sets out some basic definitions of terminology relating to material specification and testing of silicone products.
既然医疗器械的CE认证已经生效，设备制造商需要能够证明他们为特定应用采用了正确的材料和组件。为此，他们需要确切了解所采购的产品，并证明其供应商拥有必要的产品种类、技术专长，以及最重要的，确保产品完整性所需的质量程序。本文阐述了一些与硅酮产品的材料规范和测试相关的术语的基本定义。
