标准号：ISO 21534-2002
实施状态：作废
中文名称：非活性外科植入物.关节替代用植入物.特殊要求
英文名称：Non-active surgical implants - Joint replacement implants - Particular requirements
发布日期：2002-11
被替代标准：ISO 21534-2007
代替标准：ISO/DIS 21534-2001
采用标准：DIN EN 12010-1998,IDT
起草单位：ISO/TC 150
标准简介：This European 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 standard, artificial ligaments and their associated fixing devices are included in the term implant, hereinafter referred to as implants.
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 compliance with this standard are contained in or referenced in level 3 standards.
文件格式：PDF
文件大小：350.65KB
文件页数：20
（以上信息更新时间为：2019-11-23）
ISO 21534-2002 非活性外科植入物.关节替代用植入物.特殊要求.pdf
(350.65 KB)
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