目前，3D打印医疗器械研发制造正在全球范围内蓬勃发展。去年6月，总局医疗器械注册管理司主办了3D打印医疗器械审评审批研讨会，旨在通过不同领域多种角度相互交流研讨，共同加深对3D打印医疗器械相关产品的认识，增进对相关领域创新产品审评审批方式的探讨，提升对3D打印医疗器械产品的审评审批水平，促进行业健康发展。会议内容涉及3D打印医疗器械研究现状、3D打印医疗器械材料与工艺、相关产品风险特点和控制要点、质量体系控制要点以及国外发达国家和地区对相关产品注册管理和审查要求等热点话题。
根据美国FDA发布的数据，截至2015年12月，美国FDA已经批准至少85个3D打印医疗器械上市。并且已有植入人体的成功案例。
日前，美国FDA发布了“3D医疗器械”的专题报道。
What is 3-D printing
3-D printing, also called additive manufacturing, is a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete. Objects are produced from a digital 3D file, which means with 3-D printing, the conversion from a virtual computer model to a physical object can occur almost in real time.
什么是3D打印技术？
3D打印技术也被称为增材制造，是通过连续堆积单层原始材料的方式来创建一个三维物体的过程。新一层附着在前一层之上，直至整个物体完成。打印的物体基于数字3D模型文件，也就是3D打印，从虚拟电脑模型到现实物体的转化几乎可以同步完成。
Why it becomes so popular
3-D printing is spurring innovation in manufacturing, dramatically reducing the time required to design new products and allowing designs to be built that were not possible before.
The flexibility of 3-D printing allows designers to make changes easily without the need to set up additional equipment or tools.
3-D printing processes, comparing with conventional manufacturing processes, about 98 percent of the raw material is used in the finished part. But conventional manufacturing can waste up to 30 pounds of material for every 1 pound of useful material in some parts.
3D打印技术为何成为热点？
3D打印技术推动了制造业的创新，大幅的减少了设计新产品的时间，且实现了之前不可能实现的设计方案。
3D打印技术的灵活性使设计者不需要去制造其他辅助的设备或者工具就可以轻易改变产品的设计。
3D打印技术与传统制造业相比，在原材料的消耗上有着明显的优势。在一个产品完成的时候，通过3D打印技术，98%的原材料都能够被有效的被利用。而传统的制造业在某些方面，只为生产1磅有用的东西，就可能会浪费掉30磅左右的原材料。
How does a 3-D printer work
There are four basic steps: Firstly, creating a 3-D blueprint using computer-aided design(commonly called CAD) software. Secondly, preparing your printer includes refilling the raw materials and preparing the build platform. Thirdly, hit print. Forthly, after the printing is finished, post-processing your object.For example, brushing off excess powders.
3D printing technology comes in many shapes and sizes, but no matter the type of 3D printer or material you are using, the 3D printing process follows the same mentioned basic steps.
3D打印机的工作流程是什么呢？
3D打印机有4个基本的工作流程：1. 使用计算机辅助设计（通常称为计算机辅助设计）软件创建一个三维蓝图。2. 调整好打印机准备打印。比如放好原材料，准备好放置打印物品的平台。3. 开始打印。4.打印完成，对打印的物品做后处理。比如，清除掉打印物上面的灰尘。
虽然3D打印机的形状和大小各不相同，但是无论你使用的是哪种型号的打印机或者任何原材料，都需要遵循上面提到的最基本的4个步骤。
Type of 3-D printer
Over the years, a lot of and different 3D printers were created. And the ASTM International -- an international standards organization -- released standard terminology in 2012 that classified additive manufacturing technologies into seven broad categories--- Material Jetting, Binder Jetting, Powder Bed Fusion, Directed Energy Deposition, Sheet Lamination, Vat Photopolymerization.
3D打印机的类型？
经过几年的发展，大量不同的3D打印机出被制造出来。在2012年，一个国际标准制定组织---ASTM International---发布的专业术语中，3D打印机被分成7个大类-Material Jetting, Binder Jetting, Powder Bed Fusion, Directed Energy Deposition, Sheet Lamination, Vat Photopolymerization。
3-D printed medical devices go to FDA:
As of December 2015, the FDA has cleared more than 85 3D printed medical devices. And this kind of medical devices has successfully used in people, in 2012, for example, a hospital in Michigan implanted a 3D printed medical device into a 3-month-old boy with a rare bronchial condition and saved a young life.
3D打印医疗器械在美国FDA获批上市：
截至2015年12月，美国FDA已经批准至少85件通过3D打印技术制造的医疗器械产品上市。而且，3D打印的医疗器械已经有成功运用于患者的案例。2012年，在美国密歇根的一个医院里，一个3D打印的医疗器械被成功植入到了一个3个月大患有罕见支气管疾病的婴儿体内，成功的挽救了他的幼小生命。
The future of 3-D printing technology:
It changes the way companies and federal agencies do business. 3D printing has the potential to revolutionize manufacturing, allowing companies (and individuals) to design and produce products in new ways while also reducing material aste, saving energy and shortening the time needed to bring products to arket. It also helps grow the clean energy economy.
3D打印技术的前景？
3D打印技术改变了企业和联邦机构的商业模式。3D打印技术有着颠覆制造业的潜力，企业或者个人能够通过这项新技术来设计、生产产品。同时还能减少对原材料的消耗，节约能源，缩短产品上市的时间，并能够促进新能源经济的发展。
本文为北京鑫金证国际技术服务有限公司转载