DIN EN ISO 21534-2007
非活性外科植入物.关节替代植入物.特殊要求已作废

Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007); German version EN ISO 21534:2007

DIN EN ISO 21534-2007 发布历史

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 International Standard, 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.

DIN EN ISO 21534-2007由德国标准化学会 DE-DIN 发布于 2007-12，于 2009-08-01 废止。

DIN EN ISO 21534-2007 在中国标准分类中归属于: C35 矫形外科、骨科器械，在国际标准分类中归属于: 11.040.40 外科植入物、假体和矫形。

DIN EN ISO 21534-2007的历代版本如下：

• 2007年12月 DIN EN ISO 21534-2007 非活性外科植入物.关节替代植入物.特殊要求
• 2009年08月 DIN EN ISO 21534-2009 非活性外科植入物.关节替代植入物.特殊要求(ISO 21534-2007); 德文版本EN ISO 21534-2009

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标准号

DIN EN ISO 21534-2007

发布日期

2007年12月

实施日期

废止日期

2009-08-01

中国标准分类号

C35

国际标准分类号

11.040.40

发布单位

DE-DIN

代替标准

DIN EN ISO 21534-2009

适用范围

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 International Standard, 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.