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牙種植體附件檢測(cè)項(xiàng)目報(bào)價(jià)？??解決方案？??檢測(cè)周期？??樣品要求？ |
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本標(biāo)準(zhǔn)規(guī)定了鈦及鈦合金材料制成的不帶表面涂層的牙種植體的定義、性能要求和相應(yīng)的試驗(yàn)方法，并對(duì)包裝和標(biāo)識(shí)的內(nèi)容進(jìn)行了規(guī)定。本標(biāo)準(zhǔn)不包含種植體附件。本標(biāo)準(zhǔn)適用于由化學(xué)成分符合GB/T 13810-2007《外科植入物用鈦及鈦合金加工材》或ISO 5832-2、ISO 5832-3、ISO 5832-11或ASTM F67-00、ASTM F136-12a、ASTM F1295、ASTM F1472中外科植入物用鈦及鈦合金材料制成的牙種植體。
本文件規(guī)定了以鍛制鈦及鈦合金材料制成的不帶表面涂層的牙種植體的性能要求、包裝、標(biāo)識(shí)和使用說(shuō)明書(shū)，并描述了相應(yīng)的試驗(yàn)方法。本文件適用于由化學(xué)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中外科植入物用鈦及鈦合金材料制成的牙種植體。本文件不適用于牙種植體附件和增材制造鈦及鈦合金牙種植體。
本標(biāo)準(zhǔn)規(guī)定了材質(zhì)為鈦及鈦合金的牙種植體附件的性能要求和相應(yīng)的試驗(yàn)方法，以及包裝的有關(guān)內(nèi)容。本標(biāo)準(zhǔn)中牙種植體附件是指與牙種植體組合在一起使用的、用于支持種植義齒上部結(jié)構(gòu)（修復(fù)體）的各種配套部件，包括基臺(tái)、中央螺釘或螺桿。本標(biāo)準(zhǔn)中牙種植體附件也包括在上部結(jié)構(gòu)裝配之前的種植體上使用的覆蓋螺帽、愈合帽和愈合基臺(tái)。本標(biāo)準(zhǔn)不包含技工制作上部結(jié)構(gòu)所使用的器件。
本標(biāo)準(zhǔn)制定了牙種植體的臨床試驗(yàn)要求和方法。本標(biāo)準(zhǔn)適用于鈦及鈦合金材料牙種植體的臨床試驗(yàn)(不包括表面涂層鈦種植體和其他材料種植體)。
本標(biāo)準(zhǔn)界定了牙種植體和儀器、附件以及與牙種植系統(tǒng)和種植步驟相關(guān)的常用的臨床術(shù)語(yǔ)和定義。該標(biāo)準(zhǔn)不包括移植材料和膜材料。本標(biāo)準(zhǔn)也不包含以下器械：專門(mén)設(shè)計(jì)用來(lái)放置在顱頜面骨骼內(nèi)，穿過(guò)或放置于其上的器械。這些器械的主要目的是用作矯形或假體(如耳、鼻、眼的部分以及眼眶)的支抗：——贗復(fù)體；——顱面種植體；——頜面種植體。專門(mén)設(shè)計(jì)用來(lái)放置在顱頜面骨骼內(nèi)，穿過(guò)或放置于其上的器械。這些器械的主要目的是用作正畸矯治器的支抗?！N植體。
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
