GSO EN 1641:2021
牙科 牙科医疗设备 材料

Dentistry. Medical devices for dentistry. Materials

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标准号

GSO EN 1641:2021

发布

2021年

发布单位

GSO

当前最新

GSO EN 1641:2021

 

 

适用范围

This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. For the purposes of this standard these materials are defined as restorative materials. Dental implants are specifically excluded and described in EN 1642. This standard also specifies general requirements for materials used in the practice of orthodontics. This standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer. Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.

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