外科植入無(wú)機(jī)骨檢測(cè)

外科植入無(wú)機(jī)骨檢測(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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YY/T 0924.1-2014外科植入物 部分和全膝關(guān)節(jié)假體股骨和脛骨部件 第1部分:分類、定義和尺寸標(biāo)注

YY/T 0924的本部分對(duì)膝的一個(gè)或多個(gè)間室的支撐面置換的膝關(guān)節(jié)假體的股骨、脛骨和髕骨部件進(jìn)行了分類,并給出了部件定義和尺寸標(biāo)注。

YY/T 0964-2014外科植入物 生物玻璃和玻璃陶瓷材料

本標(biāo)準(zhǔn)規(guī)定了外科植入物用生物玻璃和玻璃陶瓷的材料要求和測(cè)試技術(shù),本標(biāo)準(zhǔn)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(tǒng)。生物玻璃和玻璃陶瓷與骨和軟組織的生物學(xué)反應(yīng)已經(jīng)在臨床應(yīng)用和實(shí)驗(yàn)室研究中得到驗(yàn)證。本標(biāo)準(zhǔn)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(píng)估

本標(biāo)準(zhǔn)規(guī)定了在模擬體液（SBF）中材料表面形成的磷灰石的檢測(cè)方法。

YY/T 1575-2017組織工程醫(yī)療器械產(chǎn)品 修復(fù)和替代骨組織植入物骨形成活性的體內(nèi)評(píng)價(jià)指南

本標(biāo)準(zhǔn)規(guī)定了修復(fù)和替代骨組織缺損的植入物骨形成活性的體內(nèi)評(píng)價(jià)通則。本標(biāo)準(zhǔn)中的植入物可由天然或合成生物材料(可生物降解)，或其復(fù)合物構(gòu)成。本標(biāo)準(zhǔn)描述了大鼠、兔、犬、豬、羊等不同種屬的動(dòng)物模型和相應(yīng)的試驗(yàn)程序，以及形態(tài)學(xué)、組織生物化學(xué)和生物力學(xué)分析等結(jié)果測(cè)定和評(píng)價(jià)方法。本標(biāo)準(zhǔn)適用于修復(fù)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(yàn)方法

本標(biāo)準(zhǔn)規(guī)定了評(píng)價(jià)磷酸鈣材料溶解速率的試驗(yàn)方法。本標(biāo)準(zhǔn)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(guī)定的β-磷酸三鈣和無(wú)添加或添加了其他次要成分(＜10%)的雙相復(fù)合物等。

ASTM F1581-2008外科植入物無(wú)機(jī)骨組成的標(biāo)準(zhǔn)規(guī)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(wú)機(jī)骨組成的標(biāo)準(zhǔn)規(guī)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(wú)機(jī)骨成分的標(biāo)準(zhǔn)規(guī)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(guān)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.