浅析体外诊断医用设备的行业标准YY0648-2008

On the In Vitro Diagnostic Medical Equipment Industry Standard YY 0648-2008

介绍了YY 0648-2008标准的适用范围和基本内容。阐述了对标准部分条款的理解,特别是在原来使用的GB 4793.1-2007标准的基础上对新增条款的认识和理解。

The paper introduces the scope of application of standard and basic contents of YY0648-2008. It shows part of the standard terms of understanding, especially in the original use of the GB 4793.1-2007 standard provisions based on new knowledge and understanding.