产品

BQUQ CNC加工假体关节组件 – 5 µm公差,15天交期

这些是CNC加工的假体关节组件——股骨柄、胫骨托、髋臼壳和铰链销——均采用经认证的医用棒材切割而成。我们提供5 µm位置公差、配合孔跳动≤3 µm,以及轴承表面Ra 0.2的表面粗糙度。首件典型交期为15个工作日,我们从东莞工厂发货,并提供完整的材料可追溯性。 我们如何在股骨柄锥度上保持5 µm公差 股骨柄上的锥度如果偏差超过10 µm,就会成为失效点。我们在5轴DMG MORI铣床上加工这些锥


分享此产品


获取报价

产品详情

这些是CNC加工的假体关节组件——股骨柄、胫骨托、髋臼壳和铰链销——均采用经认证的医用棒材切割而成。我们提供5 µm位置公差、配合孔跳动≤3 µm,以及轴承表面Ra 0.2的表面粗糙度。首件典型交期为15个工作日,我们从东莞工厂发货,并提供完整的材料可追溯性。

我们如何在股骨柄锥度上保持5 µm公差

股骨柄上的锥度如果偏差超过10 µm,就会成为失效点。我们在5轴DMG MORI铣床上加工这些锥度,并采用0.5 µm分辨率的在线探测。每个锥度均在一次装夹中完成切削——无重新装夹,无累积误差。随后,我们使用重复精度为1 µm的三坐标测量机(CMM)对每个锥度进行验证。这就是我们保证锥角5 µm位置公差的方式,而不仅仅是直线直径的公差。

对于抛光轴承表面,我们使用专用修光刃刀片,以1,800 rpm转速和0.05 mm切削深度进行精加工。这能产生一致的Ra 0.2表面粗糙度,且不引入残余应力。如果您的图纸要求镜面抛光,我们可以根据要求达到Ra 0.05,但这会增加3天交期。

我们为植入级零件储备的材料和热处理

我们只使用经认证的医用级别材料,并附完整钢厂证书。对于关节组件,两种主要材料是Ti6Al4V ELI(ASTM F136)和316LVM(ASTM F138)。这两种材料均以圆棒和近净锻件形式储备,来自中国和欧洲的认证供应商。我们还加工CoCrMo(ASTM F75),用于高磨损关节面。

热处理在内部真空炉中完成,采用氩气淬火。对于Ti6Al4V ELI,我们退火至950 MPa抗拉强度,硬度30 HRC。对于CoCrMo,我们进行固溶退火和时效处理,硬度达45 HRC。每批次在三个不同区域进行硬度测试,结果记录在批次卡中。我们不外包热处理——这确保了从原材料到成品零件的可追溯链完整无缺。

规格数值备注
材料Ti6Al4V ELI、316LVM、CoCrMo(ASTM F136/F138/F75)经认证的医用棒材
直径范围3 mm至200 mm圆棒和近净锻件
长度范围5 mm至400 mm单次装夹最长400 mm
公差(位置度)± 5 µm每个零件均经CMM验证
跳动(同心度)≤ 3 µm配合孔和锥度
表面粗糙度(轴承面)Ra 0.2 µm可根据要求达到Ra 0.05
硬度(Ti6Al4V ELI)30 HRC退火态,950 MPa抗拉强度
硬度(CoCrMo)45 HRC固溶退火+时效
交期(首件)15个工作日批量生产30天
起订量无起订量原型可接受1件

每次发货前的检验 – CMM和表面轮廓仪

我们发运的每个假体关节组件均附带完整检验报告。这不是可选项目——而是标准流程。我们使用重复精度为1 µm的Zeiss CMM对关键尺寸进行100%检验。表面粗糙度使用Taylor Hobson轮廓仪测量,截止长度为0.25 mm。硬度使用维氏硬度计在5 kgf载荷下验证。

我们还对每个零件进行10倍光学检查,检查边缘倒角、毛刺和刀具痕迹。如果零件未通过任何一项标准,则直接报废——不进行返工。返工医疗植入组件可能改变材料微观结构。我们更倾向于重新加工新零件。这就是为什么我们的首次合格率为98.7%,退货率低于0.2%。

为什么我们采用单次装夹加工 – 无重新装夹,无误差

假体关节组件具有复杂几何形状:锥形柄、弯曲颈部和偏置孔。如果在工序之间移动零件,就会引入基准偏移。我们通过在5轴机床上单次装夹加工所有特征来避免这一问题。零件以精密磨削的基准孔定位,所有其他特征均相对于该孔进行切削。这消除了对多个夹具的需求,并将错位风险降至零。

对于带有四个锁定孔的胫骨托,我们在同一装夹中完成钻孔、铰孔和攻丝。孔间位置公差保持在± 5 µm,这比医疗器械的ISO 1101标准更严格。我们能做到这一点,是因为我们的机床具有热补偿功能,并实时监控主轴热伸长。

匹配关节面的表面粗糙度 – Ra 0.2至Ra 0.05

关节面需要镜面光洁度以减少磨损和摩擦。我们的标准机加工表面粗糙度为Ra 0.2 µm,适用于大多数金属对聚乙烯轴承。对于金属对金属或陶瓷对金属设计,我们可以通过最终抛光工序达到Ra 0.05 µm。这使用CNC控制的抛光主轴配合金刚石研磨膏完成——不采用人工抛光,因为人工抛光不一致。

我们以与关节运动方向相同的方向测量表面粗糙度。这一点很重要,因为表面在90度方向可能看起来光滑,但在0度方向可能存在定向沟槽。我们的轮廓仪沿实际运动路径进行测量。我们在检验证书中报告Ra、Rz和Rq值。

交期和原型流程 – 从图纸到首件仅需15天

立即向我们发送STEP文件或PDF图纸。我们的工程师会在4小时内审核可制造性,并向您发送DFM报告及任何建议修改。如果图纸获批,我们在15个工作日内完成首件加工。对于100–500件的生产批次,交期为30个工作日。我们周末不休——工厂每周运行6天,CNC机床实行无人化夜班运行。

对于紧急订单,我们可以优先处理,交期10天,需加收15%附加费。这仅在我们有库存材料的情况下可行。我们在仓库中储备了Ti6Al4V ELI和316LVM棒材,因此80%的订单无需采购材料。

常见问题 – CNC加工假体关节组件

最小起订量(MOQ)是多少?

没有起订量——我们接受单件原型进行验证,批量定价从50件起。

你们可以定制锥角和表面粗糙度吗?

可以,我们严格按照您的图纸加工——锥角、孔偏置和表面粗糙度(Ra 0.2至Ra 0.05)均可通过CNC代码编程实现。

你们如何确保可追溯性和质量控制?

每个零件都带有激光蚀刻序列号,我们提供完整的批次卡,包括材料证书、热处理记录、CMM结果和表面轮廓仪读数。

定制假体关节组件的典型交期是多少?

首件在15个工作日内发货,500件的生产批次在图纸批准后30个工作日内发货。

为您的关节组件选择合适的刀具和公差

加工45 HRC的硬化CoCrMo需要特定的硬质合金牌号和涂层。如果您正在设计新零件,请参阅我们的CNC刀具选择指南,了解哪种刀具几何形状最适合您的材料。关于公差问题,我们的CNC加工公差指南解释了量产与原型加工中可实现的范围。

我们是中国东莞的精密制造工厂,拥有20年CNC加工、冲压、弹簧和散热器经验。所有假体关节组件均在我们通过ISO 13485认证的工厂内于中国制造。无起订量意味着您可以在批量下单前先测试单个零件。

12小时内获得确定报价。将您的图纸发送至sc@bquq.com或通过WhatsApp联系我们:+86 13713157787。发送您的STEP或PDF文件,我们将回复价格、交期和DFM审核意见。


相关产品

参数

参数能力范围
材料AL6061/7075, SUS303/304/316, 45#钢, T2铜, H59黄铜, POM, PEEK, 尼龙
公差±0.005mm标准,±0.003mm可按需定制
设备3/4/5轴CNC, 车铣复合, 瑞士型车床
表面处理阳极氧化, 镀镍, 镀锌, 钝化, 喷砂, 抛光
尺寸范围最大400 x 300 x 200 mm
打样72小时,样品无最小起订量
检测每批次提供完整报告,可按需提供CMM数据

联系我们报价
获取报价
我们使用cookie来改善您的在线体验。继续浏览本网站即表示您同意我们使用cookie

Cookies

Please read our Terms and Conditions and this Policy before accessing or using our Services. If you cannot agree with this Policy or the Terms and Conditions, please do not access or use our Services. If you are located in a jurisdiction outside the European Economic Area, by using our Services, you accept the Terms and Conditions and accept our privacy practices described in this Policy.
We may modify this Policy at any time, without prior notice, and changes may apply to any Personal Information we already hold about you, as well as any new Personal Information collected after the Policy is modified. If we make changes, we will notify you by revising the date at the top of this Policy. We will provide you with advanced notice if we make any material changes to how we collect, use or disclose your Personal Information that impact your rights under this Policy. If you are located in a jurisdiction other than the European Economic Area, the United Kingdom or Switzerland (collectively “European Countries”), your continued access or use of our Services after receiving the notice of changes, constitutes your acknowledgement that you accept the updated Policy. In addition, we may provide you with real time disclosures or additional information about the Personal Information handling practices of specific parts of our Services. Such notices may supplement this Policy or provide you with additional choices about how we process your Personal Information.


Cookies

Cookies are small text files stored on your device when you access most Websites on the internet or open certain emails. Among other things, Cookies allow a Website to recognize your device and remember if you've been to the Website before. Examples of information collected by Cookies include your browser type and the address of the Website from which you arrived at our Website as well as IP address and clickstream behavior (that is the pages you view and the links you click).We use the term cookie to refer to Cookies and technologies that perform a similar function to Cookies (e.g., tags, pixels, web beacons, etc.). Cookies can be read by the originating Website on each subsequent visit and by any other Website that recognizes the cookie. The Website uses Cookies in order to make the Website easier to use, to support a better user experience, including the provision of information and functionality to you, as well as to provide us with information about how the Website is used so that we can make sure it is as up to date, relevant, and error free as we can. Cookies on the Website We use Cookies to personalize your experience when you visit the Site, uniquely identify your computer for security purposes, and enable us and our third-party service providers to serve ads on our behalf across the internet.

We classify Cookies in the following categories:
 ●  Strictly Necessary Cookies
 ●  Performance Cookies
 ●  Functional Cookies
 ●  Targeting Cookies


Cookie List
A cookie is a small piece of data (text file) that a website – when visited by a user – asks your browser to store on your device in order to remember information about you, such as your language preference or login information. Those cookies are set by us and called first-party cookies. We also use third-party cookies – which are cookies from a domain different than the domain of the website you are visiting – for our advertising and marketing efforts. More specifically, we use cookies and other tracking technologies for the following purposes:

Strictly Necessary Cookies
These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Functional Cookies
These cookies enable the website to provide enhanced functionality and personalisation. They may be set by us or by third party providers whose services we have added to our pages. If you do not allow these cookies then some or all of these services may not function properly.

Performance Cookies
These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.

Targeting Cookies
These cookies may be set through our site by our advertising partners. They may be used by those companies to build a profile of your interests and show you relevant adverts on other sites. They do not store directly personal information, but are based on uniquely identifying your browser and internet device. If you do not allow these cookies, you will experience less targeted advertising.

How To Turn Off Cookies
You can choose to restrict or block Cookies through your browser settings at any time. Please note that certain Cookies may be set as soon as you visit the Website, but you can remove them using your browser settings. However, please be aware that restricting or blocking Cookies set on the Website may impact the functionality or performance of the Website or prevent you from using certain services provided through the Website. It will also affect our ability to update the Website to cater for user preferences and improve performance. Cookies within Mobile Applications

We only use Strictly Necessary Cookies on our mobile applications. These Cookies are critical to the functionality of our applications, so if you block or delete these Cookies you may not be able to use the application. These Cookies are not shared with any other application on your mobile device. We never use the Cookies from the mobile application to store personal information about you.

If you have questions or concerns regarding any information in this Privacy Policy, please contact us by email at . You can also contact us via our customer service at our Site.