标准编号：ISO 21534:2007
中文名称：无源外科植入物 关节置换植入物 特殊要求
英文名称：Non-active surgical implants — Joint replacement implants — Particular requirements
发布日期：2007-10
标准范围
This International Standard specifies particular requirements for total and partial joint replacement implants,artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this InternationalStandard, artificial ligaments and their associated fixing devices are included in the term "implant".It specifies requirements for intended performance, design attributes, materials, design evaluation,manufacturing, sterilization, packaging and information to be supplied by the manufacturer.Some tests required to demonstrate conformance to this International Standard are contained in or referenced in level 3 standards.
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