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首頁 >> 產(chǎn)品中心 >> 鈦鍛件 >> 鈦塊
  • 醫(yī)療器械用鈦方塊
  • 醫(yī)療器械用鈦方塊
  • 醫(yī)療器械用鈦方塊
  • 醫(yī)療器械用鈦方塊

醫(yī)療器械用鈦方塊

材質(zhì):Ti-6Al-4V ELI

執(zhí)行標(biāo)準(zhǔn): ASTM F136、ISO 13485

瀏覽次數(shù):

發(fā)布日期: 2025-02-15 16:43:19

全國熱線: 0917-3376170

詳細(xì)描述 / Detailed description

一、鈦方塊的應(yīng)用領(lǐng)域

鈦方塊(鈦塊、鈦合金方塊)是由鈦或鈦合金制成的塊狀材料,憑借其高強(qiáng)度、低密度、耐腐蝕和生物相容性,廣泛應(yīng)用于航空航天、醫(yī)療器械、化工、海洋工程、能源汽車等領(lǐng)域:

1、醫(yī)療器械的應(yīng)用

骨科植入物(人工關(guān)節(jié)、骨板、螺釘)。

牙科種植體及手術(shù)器械。

優(yōu)勢:生物相容性優(yōu)異,抗人體體液腐蝕,長期使用無毒性。

二、鈦方塊的執(zhí)行標(biāo)準(zhǔn)

鈦方塊的生產(chǎn)與應(yīng)用需符合國際、國家或行業(yè)標(biāo)準(zhǔn),確保其化學(xué)成分、力學(xué)性能及工藝質(zhì)量。

1、材料成分標(biāo)準(zhǔn)

ASTM B348(美國):

規(guī)定鈦及鈦合金加工材(包括塊材)的化學(xué)成分、力學(xué)性能和尺寸公差,適用于Gr.1-Gr.5等不同牌號。

GB/T 3620.1-2016(中國):

明確純鈦(TA1、TA2)及鈦合金(TC4等)的化學(xué)成分限值。

ISO 5832-2(國際):

醫(yī)療器械用鈦合金(如Ti-6Al-4V ELI)的化學(xué)成分與力學(xué)性能要求。

2、力學(xué)性能標(biāo)準(zhǔn)

ASTM E8/E8M:金屬材料拉伸試驗(yàn)方法,用于測試抗拉強(qiáng)度、屈服強(qiáng)度及延伸率。

ASTM E399:斷裂韌性測試,適用于航空航天關(guān)鍵部件。

GB/T 228.1-2021(中國):金屬材料室溫拉伸試驗(yàn)標(biāo)準(zhǔn)。

3、表面與加工標(biāo)準(zhǔn)

ASTM F86:鈦材表面清潔度與鈍化處理規(guī)范,適用于醫(yī)療植入物。

AMS 4928(航空航天材料規(guī)范):鈦合金鍛件的顯微組織與無損檢測要求。

ISO 10993(生物相容性):醫(yī)療器械需通過細(xì)胞毒性、致敏性等測試。

4、檢測與認(rèn)證

化學(xué)成分分析:采用ICP-OES(電感耦合等離子體發(fā)射光譜)或GDMS(輝光放電質(zhì)譜)。

無損檢測:X射線探傷(ASTM E94)、超聲波檢測(ASTM E317)排查內(nèi)部缺陷。

金相檢測:評估晶粒尺寸、夾雜物及微觀結(jié)構(gòu)均勻性。

三、選材與使用注意事項(xiàng)

根據(jù)應(yīng)用選材:

純鈦(TA1/TA2)適用于耐腐蝕場景(如化工)。

Ti-6Al-4V(TC4)用于高強(qiáng)度、輕量化需求(航空航天、醫(yī)療)。

加工工藝:

鍛造或軋制鈦塊需控制熱加工溫度,避免晶粒粗化。

3D打印需選用高純度球形鈦粉(符合ASTM F2924)。

鈦方塊的廣泛應(yīng)用依賴于其卓越性能及嚴(yán)格的執(zhí)行標(biāo)準(zhǔn)。在實(shí)際應(yīng)用中,需結(jié)合具體場景(如航空航天、醫(yī)療、能源)選擇符合國際/國家標(biāo)準(zhǔn)(如ASTM、ISO、GB)的鈦材,并通過規(guī)范檢測確保其力學(xué)性能、耐腐蝕性及生物相容性。隨著技術(shù)進(jìn)步,鈦方塊在高端制造領(lǐng)域的地位將進(jìn)一步提升。

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