标准编号：ISO 14630:2008
中文名称：无源外科植入物 通用要求
英文名称：Non-active surgical implants — General requirements
发布日期：2008-01
标准范围
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.NOTEThis 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.
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