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Additive manufacturing (AM) has been growing continuously over the past 20 years, enabling unprecedented tailoring to the anatomy of each patient. In Europe, custom-made devices qualify for an exemption and pass a simplified approval process. New technologies, like AM, provoke questions about the adequacy of the current regulatory framework for custom-made devices. This article addresses the regulatory requirements for such devices in Europe and discusses the implications for AM. It concludes that the legal framework for custom-made devices entails uncertainties which need to be resolved to guide manufacturers through the regulatory requirements, highlighting the specific areas of focus for AM.
The use of computational modeling and simulation (CMS) as a tool for gaining insight into the technical performance and safety of medical devices has emerged continuously over the past years. However, to rely on information and decisions derived from model predictions, it is essential to establish model credibility for the specific context of use. Limited regulatory requirements and lack of consensus on the level of verification and validation activities required result in rare use of CMS as a source of evidence in the medical device approval process. The American Society of Mechanical Engineers (ASME) developed a risk-informed framework to establish appropriate credibility requirements of a computational model: the ASME V&V 40?2018 standard. This paper aims to outline the concepts of this standard and to demonstrate its application using an example from the orthotics field. The necessary steps to establish model credibility for a custom?made 3D printed wrist hand orthosis (WHO) are presented. It is shown that the credibility requirements of each verification and validation activity depend on model risk by applying two different contexts of use to the same computational model.
Ergonomics in Product Design
(2006)
Baggage handling on airports
(2008)
Identification of noise pollution in neonatal intensive care units based on work process analyses
(2019)
Investigation of Clamping and Crushing Injuries with Electrically Height-Adjustable Therapy Beds
(2020)
This paper presents the results of the technology development project “Enabling Technologies for Piezo-Based Deformable Mirrors in Active Optics Correction Chains” conducted by OHB System AG together with its partner Münster University of Applied Sciences (MUAS). The project was funded by ESA within their General Support Technology Programme
(GSTP).
We address in this paper mainly the definition, flow-down and verification of the requirements for the Deformable Mirror (DM). The requirements were derived from a set of real space mission applications. The deformation of the mirror is performed by piezo-ceramic actuators in an unimorph configuration. The finally developed DM is able produce Zernike modes with a stroke of several tens of µm over a clear optical aperture of 50 mm in diameter. It underwent successfully a full environmental qualification campaign including thermal cycling, shock- and vibration testing, as well as exposure to
proton and γ–ray radiation. Thermal and performance tests were performed in the temperature range from 100 K to 300 K.
Furthermore, the DM sustained all vibration (random 17.8 g RMS and sinus) and shock (300 g) testing. Thereby all criticalities which were identified a previous study have been overcome successfully.
A Technology Readiness Level (TRL) of 5 is reached, as the component has been validated in relevant environment. Based on the high level of maturity, this deformable mirror is now ready for the incorporation in future flight instruments. The achieved TRL of 5 is sufficient for the status of a PDR at payload level and gives thus a very good basis for all kinds of potential B2, C/D payload developments.
We present our latest results on a refined unimorph deformable mirror which was developed in the frame of the ESA GSTP activity ”Enabling Technologies for Piezo-Based Deformable Mirrors in Active Optics Correction Chains”. The identified baseline concept with the soft piezoceramic material PIC151 successfully sustained all vibration requirements (17.8 gRMS random and 20 g sine) and shock testing (300 g SRS). We cover the mirror design development which reduces the stress in the brittle piezo-ceramic by 90 % compared to the design from
a former GSTP activity. We briefly address the optical characterization of the deformable mirror, namely the achieved Zernike amplitudes as well as the unpowered surface deformation (1.7 µm) and active flattening (12.3 nmRMS). The mirror produces low-order Zernike modes with a stroke of several tens of micrometer over a correction aperture of 50 mm, which makes the mirror a versatile tool for space telescopes.
Laser shock peening is a new and important surface treatment technique that can enhance the mechanical properties of metal materials. Normally, the nanosecond laser with pulse-width between 5 ns and 20 ns is used to induce a high-pressure shock wave that can generate plastic deformation in the top layer of metals. The femtosecond laser shock peening in the air has been studied recently, which can induce higher pressure shock wave than that of traditional nanosecond laser shock peening in a very short time. The NiTi alloy is processed by femtosecond laser shock peening, then a nanoindentation device is used to measure its surface hardness and residual stress. The hardness results of NiTi alloy before and after treatment show that the femtosecond laser shock peening can increase the hardness of NiTi alloy, which also shows that the femtosecond laser can be used to perform laser shock peening on NiTi alloy without coating.
The experiment study presents the influence of femtosecond laser shock peening (FsLSP) without a protective layer in the air on the surface hardness and surface mechanical property of NiTi shape memory alloy. Femtosecond laser shock peening is a new possibility of direct laser ablation without any protective layer under atmospheric conditions, which can produce intense shock waves with low pulse energy in the air. The average surface roughness values of the NiTi alloy samples were measured, because the surface roughness may affect its friction resistance. The results showed that the surface roughness of NiTi increased after femtosecond laser shock peening treatment. In comparison with the initial state, the coefficient of friction decreased and surface microhardness increased after femtosecond laser shock peening treatment with different FsLSP parameters. This improvement of wear properties may be attributed to the enhancement of surface microhardness and surface titanium oxide layer induced by the shock wave and laser ablation during FsLSP treatment.
In this study, we use a hybrid mode-locked external cavity diode laser with subsequent amplification and pulse compression. The system provides laser pulses of 440 fs width (assuming a sech² pulse shape) and 160 mW average output power at a repetition rate of 383.1 MHz. The laser oscillator consists of a double quantum well laser diode with a gain segment of 1080 μm length and an absorber element of 80 μm lengths. The chip’s back facet is covered with a high reflective coating, the front facet with an anti-reflective coating. The resonator itself is operated in a collimated geometry and folded by two dielectric mirrors. The used output coupler provides a transmission of 20 percent, which is coupled into a tapered amplifier. Two Faraday isolators are used to decouple the laser and the amplifier from any back reflections. Subsequently, the pulses are compressed using a single pass Martinez type pulse compressor …