标准摘要
[中文适用范围]： 本国际标准规定了全关节置换植入物和部分关节置换植入物、人工韧带和骨水泥（以下简称植入物）的特殊要求。 就本国际标准而言，人工韧带及其相关固定装置包含在术语“植入物”中。 它规定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。 证明符合本国际标准所需的一些测试包含在 3 级标准中或在 3 级标准中引用。 [外文原描述]： ISO 21534:2007 specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, referred to as implants in the text. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant". ISO 21534:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.
英文名称Non-active surgical implants — Joint replacement implants — Particular requirements