外科植入無機骨檢測

外科植入無機骨檢測項目報價？??解決方案？??檢測周期？??樣品要求？

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YY/T 0924.1-2014外科植入物 部分和全膝關節假體股骨和脛骨部件 第1部分:分類、定義和尺寸標注

YY/T 0924的本部分對膝的一個或多個間室的支撐面置換的膝關節假體的股骨、脛骨和髕骨部件進行了分類,并給出了部件定義和尺寸標注。

YY/T 0964-2014外科植入物 生物玻璃和玻璃陶瓷材料

本標準規定了外科植入物用生物玻璃和玻璃陶瓷的材料要求和測試技術,本標準所述材料可用于多孔狀和粉末狀外科植入物,也可用于外科器械的涂層,但不包括藥物輸送系統。生物玻璃和玻璃陶瓷與骨和軟組織的生物學反應已經在臨床應用和實驗室研究中得到驗證。本標準不包含合成羥基磷灰石、羥基磷灰石涂層,氧化鋁陶瓷,α-磷酸三鈣和β-磷酸三鈣以及白磷鈣石。

YY/T 1447-2016外科植入物 植入材料磷灰石形成能力的體外評估

本標準規定了在模擬體液（SBF）中材料表面形成的磷灰石的檢測方法。

YY/T 1575-2017組織工程醫療器械產品 修復和替代骨組織植入物骨形成活性的體內評價指南

本標準規定了修復和替代骨組織缺損的植入物骨形成活性的體內評價通則。本標準中的植入物可由天然或合成生物材料(可生物降解)，或其復合物構成。本標準描述了大鼠、兔、犬、豬、羊等不同種屬的動物模型和相應的試驗程序，以及形態學、組織生物化學和生物力學分析等結果測定和評價方法。本標準適用于修復和替代骨組織缺損的植入物。

YY/T 1640-2018外科植入物 磷酸鈣顆粒、制品和涂層溶解性的試驗方法

本標準規定了評價磷酸鈣材料溶解速率的試驗方法。本標準適用于外科植入物用磷酸鈣材料，包括符合GB 23101.1、GB 23101.2的羥基磷灰石，符合YY/T 0683規定的β-磷酸三鈣和無添加或添加了其他次要成分(＜10%)的雙相復合物等。

ASTM F1581-2008外科植入物無機骨組成的標準規范

1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix X1). 1.2 The biological response to apatite in soft tissue and bone has been characterized by a history of clinical use and by laboratory studies (1, 2, 3). Xenogeneic bone, with organic components present, has been shown to be antigenic in the human host (4) whereas the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in human clinical use (5, 6, 7). 1.3 This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. 1.4 This standard does not pruport to address all of the safety concerns, such as health concerns due to the presence of transmissible disease, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. (See Appendix X2).

ASTM F1581-2008(2016)外科植入物用無機骨組成的標準規格

1.1x00a0;This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix X1). 1.2x00a0;The biological response to apatite in soft tissue and bone has been characterized by a history of clinical use and by laboratory studies (1, 2, 3).2 Xenogeneic bone, with organic components present, has been shown to be antigenic in the human host (4) whereas the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in human clinical use (5, 6, 7). 1.3x00a0;This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. 1.4x00a0;The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5x00a0;Warningx2014;Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Safety Data Sheet (DS) for details and EPAx2019;s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law. 1.6x00a0;This standard does not purport to address all of the safety concerns, such as health concerns due to the presence of transmissible disease, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. (See Appendix X2).

ASTM F1581-2008(2020)外科植入物用無機骨成分的標準規范

1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix X1). 1.2 The biological response to apatite in soft tissue and bone has been characterized by a history of clinical use and by laboratory studies (1, 2, 3).2 Xenogeneic bone, with organic components present, has been shown to be antigenic in the human host (4) whereas the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in human clinical use (5, 6, 7). 1.3 This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 Warning—Mercury has been designated by many regulatory agencies as a hazardous substance that can cause serious medical issues. Mercury, or its vapor, has been demonstrated to be hazardous to health and corrosive to materials. Use caution when handling mercury and mercury-containing products. See the applicable product Safety Data Sheet (SDS) for additional information. The potential exists that selling mercury or mercury-containing products, or both, is prohibited by local or national law. Users must determine legality of sales in their location. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriat

DIN EN ISO 13504-2012牙科. 牙科植體位置和治療使用儀器和相關配件的一般要求 (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.