颌面固定植入物检测

T/CAMDI 070-2021 增材制造聚醚醚酮（PEEK）个性化颅颌面植入器械

本标准规定了以增材制造加工技术为主的PEEK个性化颅颌面植入器械的原材料、质量评价、检验方法、质量控制、制造、灭菌、包装、随访等信息的要求。 本标准适用于通过外科手术植入颅颌面骨骼，用于颅颌面骨骼缺损修复、外形修整、固位与稳定的增材制造PEEK植入式医疗器械设计制造规范。 本标准涵盖了由原料

T/CSBM 0023-2022 3D打印个性化 钛合金下颌骨修复重建植入物

1 要求 1.1 假体CAD设计模型 1.1.1  个性化植入物的设计要求和主体结构方案应由主诊医师提出。 1.1.2 个性化植入物的延伸固定板与下颌体（体部）需要稳定可靠的连接。延伸固定板厚度应≥1mm，厚度宜采用2.0mm~2.4mm；延伸

Customized titanium alloy for lower jawbone reconstruction implant fabricated by three-dimensional printing

GOST ISO 14602-2012 源外科植入物.骨折固定术用植入物.详细要求

Non-active surgical implants. Implants for osteosynthesis. Particular requirements

EN ISO 22794:2009 牙科.口腔和上颌面外科中骨填充物和增加物用可植入材料.技术文档内容

This International Standard applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting

Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file

KS P ISO 9583-2009(2019 外科植入物损检测金属外科植入物的液体渗透检验

Implants for surgery－Non-destructive testing－Liquid penetrant inspection of metallic surgical implants

EN ISO 22794:2007 牙科.口腔和上颌面外科中骨填充物和增加物用可植入材料.技术文档内容

Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file

ISO 22794:2007 牙科学.口腔和上颌面外科中骨填充物和增加物用植入材料.技术文档内容

This International Standard applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting

Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file

NF S91-155*NF EN ISO 22794:2009 牙科学.口腔和上颌面外科中骨填充物和增加物用植入材料.技术文档内容

Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file.

BS EN ISO 22794:2007 牙科学.口腔和上颌面外科中骨填充物和增加物用植入材料.技术文档内容

This International Standard applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting

Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file

DIN EN ISO 22794:2007 牙科.口腔和上颌面外科中骨填充物和增加物用可植入材料.技术文档内容

This international Standard applies to implantable materials,whether resorbable or non-resorbable,used as dental devices for filling and augmenting

Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007); German version EN ISO 22794:2007

BS EN ISO 22794:2009 牙科学.口腔和上颌面外科中骨填充物和增加物用植入材料.技术文档内容

Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file

KS P ISO 22794:2009 牙科学.口腔和上颌面外科中骨填充物和增加物用植入材料.技术文档内容

이 표준은 구강악안면외과에서 골 충전 및 증대용 치과의료기기로 사용되는 흡수성 또는 비흡수

Dentistry－Implantable materials for bone filling and augmentation in oral and maxillofacial surgery－Contents of a technical file

KS P ISO 9584-2009(2019 外科植入物损检测铸造金属外科植入物的射线照相检验

Implants for surgery－Non-destructive testing－Radiographic examination of cast metallic surgical implants

YY/T 0856-2011 骨接合植入物.金属角度固定器

本标准旨在为骨科内固定手术中使用的金属角度固定器（以下简称角度固定器）提供全面的参考。本标准建立了对角度固定器的几何特性和功能特性进行分类和定义一致的方法。本标准也对角度固定器的材料、制造、灭菌、包装、标记、标签和使用说明书给出了标准规定，对角度固定器在体内与使用相关的重要力学性能也给出了标准试验方

Implants for orthosynthesis.Metallic angled fixation device

YY 0346-2002 骨接合植入物 金属股骨颈固定钉

本标准规定了金属股骨颈固定钉的分类、要求、试验方法、检验规则、标志、使用说明书、包装、运输和贮存。 本标准适用于金属股骨颈固定钉，该产品供骨科手术时作股骨颈骨折内固定用

Implants for osteosynthesis----Metal nail of neck fixation of femur

YY/T 0525-2009 牙科学 口腔颌面外科用骨填充及骨增加植入性材料 技术文件内容

本标准适用于口腔颌面外科中植入性骨填充及骨增加材料，包括可吸收型和不可吸收型。本标准不包括主要组成为纯羟基磷灰石（>90%）的产品。 本标准包括这些植入性口腔材料的物理化学、机械、生物及临床性能和表现的评价。 本标准不包括主要用于自体移植物、异体移植物和膜材料，以及主要预期用于药物释放的产品

Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file

CNS 13382-30-1996 外科植入物–成人之股骨端固定用装置

本标准适用于成人股骨远近端之骨折与截骨时固定用金属植入物之材料、尺度、表面处理、包装及标示

Implants for Surgery-Fixation Devices for Use in the Ends of the Femur in Adults

DOD A-A-53914-1989 输入颌鼻甲骨电线

This commercial item description covers a titanium wire designed for use with titanium mesh mandibular implants

WIRE, MAXILLOFACIAL, IMPLANT

TCVN 6799-2001 外科植入物.用于成人股骨端的固定器

Implants for surgery.Fixation divices fore use in the ends of the femur in adults

CNS 13382.30-1996 外科植入物–成人之股骨端固定用装置

Implants for Surgery-Fixation Devices for Use in the Ends of the Femur in Adults

ISO 8615:1991 外科植入物.用于成人股骨端的固定器

Specifies the materials, dimensions, surface finish, packaging and marking. Applies to nails and screws, nail plates and blade plates, fixation

Implants for surgery; fixation devices for use in the ends of the femur in adults

BS EN 12564:1999 稳定的外科植入物.关节代替植入物.膝关节代替植入物的特殊要求

Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements for Knee Joint Replacement Implants Ratified European Text

BS EN 125:2010+A1:2015 稳定的外科植入物.关节代替植入物.膝关节代替植入物的特殊要求

Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements for Knee Joint Replacement Implants Ratified European Text

EN 12564:1998 稳定的外科植入物.关节代替植入物.膝关节代替植入物的特殊要求

This European Standard provides specific requirements for knee joint replacement implarns.With regard to safety,The standard gives requirements

Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements for Knee Joint Replacement Implants Ratified European Text

BS EN ISO 14602:2010 稳定性外科植入物.接骨术植入物.详细要求

This International Standard specifies particular requirements for non-active surgical implants for osteosynthesis, hereafter referred to as implants.

Non-active surgical implants - Implants for osteosynthesis - Particular requirements

EN ISO 14602:2010 稳定性外科植入物.接骨术植入物.详细要求

Non-active surgical implants - Implants for osteosynthesis - Particular requirements

EN ISO 14602:2011 稳定性外科植入物.接骨术植入物.详细要求

This International Standard specifies particular requirements for non-active surgical implants forosteosynthesis, hereafter referred to as implants

Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)

BS EN ISO 14602:2011 稳定性外科植入物.接骨术植入物.详细要求

Non-active surgical implants. Implants for osteosynthesis. Particular requirements

DIN EN ISO 14602:2012 稳定性外科植入物.接骨术植入物.详细要求

Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010); German version EN ISO 14602:2011

GOST R 57388-2017 外科植入物. 内部固定植入物用可吸收性板材和螺丝的标准规格和试验方法

Implants for surgery. Standard specification and test methods for absorbable plates and screws for internal fixation implants