口腔技术文件 牙科种植系统技术文件的内容 (ISO 10451:2026)

[中文适用范围]： 适用范围 本文件规定了用于证明种植体牙科植入物满足监管要求的技术文件内容要求。该种植体牙科植入物可包括：种植体体；种植体基台；基台螺丝；种植体连接件；种植体连接件螺丝；修复用螺丝；种植体覆盖螺丝；穿龈愈合组件。 本文件还规定了预期用途、性能、设计属性、组件、生物相容性、制造、包装、灭菌、有效期、标记、标签及制造商提供的信息等要求。 本文件不适用于以下设备： - 含有人体或动物成分或具有生物活性特征的牙科种植体； - 无预制连接件而定制制造的装置； - 用于口腔颌面外科手术中骨填充和骨增强的可植入材料； - 用于口腔颌面外科手术中引导组织再生的膜材料； - 明确指定作为牙科种植体系统一部分使用的特定器械。 注1：ISO 22794规定了用于口腔颌面外科手术中骨填充和骨增强的可植入材料技术文件所需内容。ISO 22803规定了用于口腔颌面外科手术中引导组织再生的膜材料技术文件所需内容。上述材料需单独编制技术文件。 注2：ISO 13504规定了作为牙科种植体系统一部分使用的特定器械的通用要求。此类器械需单独编制技术文件。 注3：定制制造装置的定义参见IMDRF/PMD WG/N49 [5]。 [外文原描述]： This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for an endosseous dental implant that can include: implant body; implant abutment; abutment screw; implant connecting part; implant connecting part screw; prosthetic screw; implant cover screw; transmucosal healing component. This document also specifies requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer. This document does not apply to the following devices: dental implants incorporating animal or human components or bioactive characteristics; custom-made devices that have no pre-fabricated connection; implantable materials for bone filling and augmentation in oral and maxillofacial surgery; membrane materials for guided tissue regeneration in oral and maxillofacial surgery; specific instruments indicated to be used as part of a dental implant system. NOTE 1 ISO 22794 specifies the necessary content of technical files for implantable materials for bone filling and augmentation in oral and maxillofacial surgery. ISO 22803 specifies the necessary content of technical files for membrane materials for guided tissue regeneration in oral and maxillofacial surgery. These materials require a separate technical file. NOTE 2 ISO 13504 gives the general requirements for specific instruments indicated to be used as part of a dental implant system. These instruments require a separate technical file. NOTE 3 Custom-made devices are defined in IMDRF/PMD WG/N49 [5] .