牙种植体附件检测

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YY 0315-2016钛及钛合金牙种植体

本标准规定了钛及钛合金材料制成的不带表面涂层的牙种植体的定义、性能要求和相应的试验方法，并对包装和标识的内容进行了规定。本标准不包含种植体附件。本标准适用于由化学成分符合GB/T 13810-2007《外科植入物用钛及钛合金加工材》或ISO 5832-2、ISO 5832-3、ISO 5832-11或ASTM F67-00、ASTM F136-12a、ASTM F1295、ASTM F1472中外科植入物用钛及钛合金材料制成的牙种植体。

YY 0315-2023钛及钛合金牙种植体

本文件规定了以锻制钛及钛合金材料制成的不带表面涂层的牙种植体的性能要求、包装、标识和使用说明书，并描述了相应的试验方法。本文件适用于由化学成分符合GB/T 13810或ISO 5832-2、ISO 5832-3、ISO 5832-11或ASTM F67、ASTM F136、ASTM F1295、ASTM F1472中外科植入物用钛及钛合金材料制成的牙种植体。本文件不适用于牙种植体附件和增材制造钛及钛合金牙种植体。

YY/T 0520-2009钛及钛合金材质牙种植体附件

本标准规定了材质为钛及钛合金的牙种植体附件的性能要求和相应的试验方法，以及包装的有关内容。本标准中牙种植体附件是指与牙种植体组合在一起使用的、用于支持种植义齿上部结构（修复体）的各种配套部件，包括基台、中央螺钉或螺杆。本标准中牙种植体附件也包括在上部结构装配之前的种植体上使用的覆盖螺帽、愈合帽和愈合基台。本标准不包含技工制作上部结构所使用的器件。

YY/T 1305-2015钛及钛合金牙种植体临床试验指南

本标准制定了牙种植体的临床试验要求和方法。本标准适用于钛及钛合金材料牙种植体的临床试验(不包括表面涂层钛种植体和其他材料种植体)。

YY/T 1619-2018牙科学 种植体系统及相关过程的术语

本标准界定了牙种植体和仪器、附件以及与牙种植系统和种植步骤相关的常用的临床术语和定义。该标准不包括移植材料和膜材料。本标准也不包含以下器械：专门设计用来放置在颅颌面骨骼内，穿过或放置于其上的器械。这些器械的主要目的是用作矫形或假体(如耳、鼻、眼的部分以及眼眶)的支抗：——赝复体；——颅面种植体；——颌面种植体。专门设计用来放置在颅颌面骨骼内，穿过或放置于其上的器械。这些器械的主要目的是用作正畸矫治器的支抗。——正畸种植体。

DIN EN 1641-2010牙科学.牙科用医疗器械.材料.德文版本EN 1641-2009

This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. For the purposes of this standard these materials are defined as restorative materials. Dental implants are specifically excluded and described in EN 1642. This standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.

DIN EN 1642-2012牙科学.牙科用医疗器械.牙科植入物

This European Standard specifies general requirements for dental implants. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641.This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.

DIN EN ISO 10451-2010牙科学.牙移植系统技术文档的内容(ISO 10451-2010);德文版本EN ISO 10451-2010

This International Standard specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof which remains in the mouth after surgery.This International Standard is not applicable to instruments and other parts specifically made for the dental implant system but which do not remain in the mouth. However, documentation relating to these components may be included in the technical file.

DIN EN ISO 11953-2010牙科.植入物.手持扳牙器械的临床性能(ISO 11953-2010);德文版本EN ISO 11953-2010

This International Standard describes a classification system for hand-held torque wrenches intended for clinical use. It speifies their performance requirements in terms of accuracy and reproducibility and resistance to reprocessing. The standard describes the tests to be used and marking and labelling requirements are specified. This International Standard does not include electronically controlled devices.

DIN EN ISO 13504-2012牙科. 牙科植体位置和治疗使用仪器和相关配件的一般要求 (ISO 13504-2012); 德文版本EN ISO 13504-2012

This Standard specifies general requirements for instruments and related accessories to be used specifically in dental implantology in the craniofacial area. These requirements apply to instruments when they are manufactured. This includes instruments for single-use and reusable instruments.This International Standard applies to instruments used on the patient which are manually driven instruments and to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.With regard to safety this International Standard gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.

DIN EN ISO 14801-2017牙科学.植入物.骨质牙科植入物的动态疲劳试验(ISO 14801-2016);德文版本EN ISO 14801-2016

This standard specifies a method of fatigue testing of single post endosseous dental implants of the transmucosal type and their premanufactured prosthetic components. It is most useful for comparing endosseous dental implants of different designs or sizes. While it simulates the functional loading of an endosseous dental implant body and its premanufactured prosthetic components under \"worst case\" conditions, this standard is not applicable for predicting the in vivo performance of an endosseous dental implant or prosthesis, particularly if multiple dental implants are used for a prosthesis.

DIN EN ISO 16443-2014牙科. 牙科植入物系统和相关程序词汇 (ISO 16443-2014); 德文版本EN ISO 16443-2014

This document specifies terms and definitions for dental implants, instruments and accessories, and the most commonly used clinical terms in the field of dental implantology.

DIN EN ISO 16498-2013牙科学.临床应用小的牙科植体数据集(ISO 16498-2013).德文版本EN ISO 16498-2013

This International Standard specifies the minimal data set to be recorded for a patient receiving dental implant treatment. This will comprise the locations and types of dental implant bodies, connecting components and adjunctive devices, including grafting materials, placed in a patients jaw(s). The final prosthesis is excluded. This information will be recorded by the responsible clinician in the patient's file and should be made available to the patient by the clinician(s) who provided the care.

DIN EN ISO 17509-2017牙科.手机用力矩式发送器(ISO 17509-2016);德文版本EN ISO 17509-2016

This International Standard specifies requirements for torque transmitters to be used in oral implantology in conjunction with a dental handpiece as an accessory in the placement of dental implants and the further manipulation of connecting parts in the craniofacial area. This International Standard applies to torque transmitters used for placement and for removal in the oral cavity of the patient which are connected to power-driven systems having torque control mechanism, but does not apply to the power-driven systems themselves. This International Standard does not include the dental implant nor parts that would be connected to it. With regard to safety, this International Standard gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, reprocessing and information to be supplied by the manufacturer.

DIN EN ISO 17937-2016牙科. 骨凿 (ISO 17937-2015); 德文版本EN ISO 17937-2015

This Standard specifies design and dimensional requirements and test methods for osteotomes. Osteotomes are used in dentistry in the area of implantology for the manual preparation of the implant bed, e. g. bone compaction and sinus floor elevation.

DIN EN ISO 19429-2016牙科.牙科植入物的命名系统(ISO 19429-2015).德文版本EN ISO 19429-2016

This International Standard provides a system for designating the location of an implant body within a jaw, and is intended for use with the scheme described in ISO 3950. It does not in itself indicate whether the device is visible within the oral cavity or the presence of transmucosal components or implant restorations. Since the system describes location but not restoration form, it is not necessary to use the quadrant designation numbers 5-8 which are employed when indicating a primary tooth. This information should be recorded by the responsible clinician in the patient's file and made available to the patient by the clinician(s) who provided the care.

DIN 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(ISO 22794:2007,修正版本 2009-01-15),德文版本 EN ISO 22794:2009

This International Standard applies to implantable materials, whether resorbable or non-resorbable, used asdental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentiallypure (> 90 %) hydroxyapatite are not covered by this International Standard.Evaluation includes the physico-chemical, mechanical, biological and ciinical aspects and behaviour of theseimplantable dental materials.Materials such as autografts, allografts and membranes, and products for which the primary intended use is todeliver a medicinal product, are not covered by this International Standard.

DIN EN ISO 22803-2006牙科学.口腔及颌面外科中受控制的组织再生用薄膜材料.技术文档的内容

This International Standard gives the requirements for a technical file on the evaluation of the chemical,physical, mechanical, biological and clinical aspects and behaviour of membrane materials, whetherresorbable, partially resorbable or non-resorbable, which are used-- for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality-- in contact with teeth and/or dental implants,-- for prevention of epithelial migration in periodontal surgery,-- for the augmentation of bone prior to the planned insertion of dental implants,-- and/or for augmentation of bone for stabilization of dental prostheses.This International Standard is not applicable to materials whose primary intended use is to deliver a medicinalproduct, autografts and allografts, or materials intended to act through pharmacological, immunological ormetabolic means.