ISO 14630:2008 无源外科植入物 通用要求

标准编号：ISO 14630:2008

中文名称：无源外科植入物 通用要求

英文名称：Non-active surgical implants — General requirements

发布日期：2008-01

标准范围

ISO 14630:2008规定了非活性外科植入物的一般要求。ISO 14630:2008不适用于牙科植入物、牙科修复材料、经牙髓和经牙根植入物、眼内透镜和利用活动物组织的植入物。关于安全性，ISO 14630:2008给出了制造商提供的预期性能、设计属性、材料、设计评估、制造、灭菌、包装和信息的要求，以及证明符合这些要求的测试。2级和3级标准中给出或提及了附加测试。

ISO 14630:2008 specifies general requirements for non-active surgical implants. ISO 14630:2008 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.With regard to safety, ISO 14630:2008 gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional tests are given or referred to in level 2 and level 3 standards.

标准预览图