Legal and Regulatory

TüvSüd为制造商提供3D打印标准和法规清单

In response to the Covid-19 pandemic, the 3D printing industry has successfully plugged many of the supply chain gaps in the medical sector resulting from border closures, increased demand, and workforce shortages.

To make sure these products adhere to the strict quality requirements and legal regulations medical devices are subject to, technical service gianttüvSüd已经将几个清单用于3D打印过程,并将其提供给整个大流行的制造商。

TüvSüd的加法制造业负责人Gregor Reischle说:“当关闭边界以停止Covid-19的传播时,公司被迫调整其供应链。”雷电竞充值

德国慕尼黑TüvSüd的总部。图像通过TüvSüd。
Headquarter of TÜV SÜD
in Munich, Germany. Image via TÜV SÜD.

3D printing during the pandemic

Since the beginning of the coronavirus pandemic, additive manufacturing sites with 3D printer access have reacted to the need to fill in gaps that had appeared in the supply chain, re-purposing their production processes to meet the demand for nasal swabs, ventilator components, and PPE, in addition to many other medical components.

3DPI has been trackinghow the 3D printing industry has responded to the Covid-19 pandemicsince April, detailing the projects and initiatives set up by professional AM providers, makers, and designers in the 3D printing community.

The likes ofPhotocentric,该公司签订了英国政府制造的合同7.6 million 3D printed protective face shields在接下来的几个月中,University of Sheffield, which also received government funding toscale up its delivery of PPEto a refugee camp in Jordan, have been busy plugging the global PPE shortage.

Elsewhere, students from Massachusetts-basedSmith Collegehave produced a novel “Smithvent”partially-3D printed ventilator, while有用的工程volunteers developed a 3D printed timing mechanism of an emergency ventilatorbased on a U.S. Army design from 1965。最近,全球再保险业务慕尼黑and technology research firmFraunhoferawarded €1m as part of a competition to3D print medical devices for COVID-19 sufferers

According to TÜV SÜD, even before the pandemic arose, additive manufacturing in the medical sector had been forecast by analysts to be worth some $20 billion. Presently, 3D printing is utilized in this sector for a multitude of applications spanning general healthcare to high-precision personalized devices.

The ARMEE ventilator. Photo via Warren Koch.
Armee呼吸机根据1965年的美国陆军设计。照片通过Warren Koch摄。

The checklists

在进入市场之前,3D打印的医疗设备必须证明它们符合一系列安全,质量和性能标准。合格评估需要时间,因此TüvSüd开发了几个清单,以指导制造商迅速可靠地实施这些要求。

这些清单列出了与关键标准和法规有关的医疗部门添加剂制造面临的主要要求。雷电竞充值对于测试实验室,医疗保健专家和公众来说,这些清单在整个大流行中都免费提供。

国际标准组织国际ASTMandISOhave also provided free access to relevant standards for PPE and medical devices.

除了th期间扮演了重要角色e pandemic, believes additive manufacturing is having a positive impact on the medical and healthcare sector more generally, too. “There are many indications that fast, integrated supply chain networks with local production operations will become the new normal,” he said.

In addition to providing checklists, TÜV SÜD also provides specific tests for additive manufacturing processes, enabling 3D printing companies to verify their conformity with certain requirements.

从左起:格雷戈尔·里施(Gregor Reischle),TüvSüd的添加剂制造主管,霍尔格·林德纳(Holger Lindner),TüvSüd的CEO产品服务,帕特里夏·拉科纳(Patricia Lacina),美国法兰克福美国领事馆的总领事,伦纳德·莫里斯西(Leonard F. Morrissey)International,ASTM International全球添加剂制造计划主管Mohsen Se雷电竞充值ifi博士。通过TüvSüd的照片。
从左起:格雷戈尔·里施(Gregor Reischle),TüvSüd的雷电竞充值添加剂制造业负责人,霍尔格·林德纳(Holger Lindner),TüvSüd的首席执行官,帕特里亚·拉科纳(Patricia Lacina)的产品服务,美国法兰克福美国领事馆的总领事,伦纳德·莫里斯西(Leonard F. Morrissey)ASTM International,ASTM International全球添加剂制造计划主管Mohsen Se雷电竞充值ifi博士。通过TüvSüd的照片。

Collaborating with industry

tüvSüdhas also partnered with several 3D printing firms, organizations, and authorities to help combat the effects of the coronavirus pandemic.

Production software provider3年在建立一个平台以协调和组织整个大流行的基本产品供应的平台之后,将TüvSüd的清单嵌入了其工作流程中。

TüvSüd还与3D打印机制造商合作Ultimakeron its first checklist, in addition to participating in an inter-agency collaboration between theNanyang Technological University(NTU) andSingapore’s National Additive Manufacturing Innovation Cluster(NAMIC) to guide manufacturers through relevant testing requirements.

技术公司是面向用户网络的成员移动性增加(MGA)这是在3D打印面遮阳板,口罩和呼吸机上构建用例和常见问题的数据库。TüvSüd支持成员制造商实施监管要求。

3YOURMIND infographic showing summary of the project. Image via 3YOURMIND
3您的信息图显示了其COVID响应项目的摘要。图片通过3 YourMind

提名2020 3D Printing Industry Awards仍然开放,让我们知道谁在领导该行业。

第四版3D Printing Industry Awards Trophy Design Competition现在正在进行。输入您的设计,有机会赢得CraftBot Flow 3D打印机。

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Featured image shows TÜV SÜD conference hall. Photo by Kubi Sertoglu.