标准号：ISO 14630-2005
实施状态：作废
中文名称：非有源外科植入物.一般要求
英文名称：Non-active surgical implants - General requirements
发布日期：2005-05
被替代标准：ISO 14630-2008
代替标准：ISO 14630-1997;ISO/FDIS 14630-2005
采用标准：DIN EN ISO 14630-2005,IDT;BS EN ISO 14630-2005,IDT;EN ISO 14630-2005,IDT;NF S94-001-2005,IDT;OENORM EN ISO 14630-2005,IDT;UNE-EN ISO 14630-2005,IDT
起草单位：ISO/TC 150
标准简介：This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. It is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses.
With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests required to demonstrate compliance with these requirements. Additional tests are given or referred to in Level 2 and Level 3 standards.
文件格式：PDF
文件大小：194.97KB
文件页数：20
（以上信息更新时间为：2019-11-22）
ISO 14630-2005 非有源外科植入物.一般要求.pdf
(194.97 KB)
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