标准号：ISO 14630-2008
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：2008-01
被替代标准：ISO 14630-2012
代替标准：ISO 14630-2005;ISO/FDIS 14630-2007
采用标准：DIN EN ISO 14630-2008,IDT;DIN EN ISO 14630-2009,IDT;DIN EN ISO 14630-2006,IDT;DIN EN ISO 14630/A1-2009,IDT;BS EN ISO 14630-2008,IDT;BS EN ISO 14630-2009,IDT;EN ISO 14630-2008,IDT;EN ISO 14630-2009,IDT;prEN ISO 14630-2008,IDT;NF S94-001-2008,IDT;NF S94-001-2009,IDT;S94-001PR,IDT;SN EN ISO 14630-2008,IDT;SN EN ISO 14630-2009,IDT;OENORM EN ISO 14630-2008,IDT;OENORM EN ISO 14630-2009,IDT;PN-EN ISO 14630-2008,IDT;PN-EN ISO 14630-2009,IDT;UNE-EN ISO 14630-2008,IDT;UNE-EN ISO 14630-2009,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. This International Standard is not applicable to dental implants, dental restorative materials transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.
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 to demonstrate compliance with these requirements. Additional tests are given Q(
referred to in level 2 and level 3 standards.
NOTE This International Standard does not require that the manufacturer have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485 could be appropriate to help ensure the implant achieves its intended performance.
文件格式：PDF
文件大小：182.77KB
文件页数：22
（以上信息更新时间为：2019-11-22）
ISO 14630-2008 非有源外科植入物.一般要求.pdf
(182.77 KB)
|
|
