Medical Device Tracking Guidance for Industry And FDA Staff March 2025
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작성자 Louie 작성일25-09-26 19:56 조회2회 댓글0건본문
FDA is issuing this guidance to announce that both the list of devices topic to medical machine monitoring necessities, and the listing of medical units released from monitoring requirements, have been up to date. This updated guidance identifies all affected devices (those tracked and those released from tracking) in desk format. The desk consists of two fields to describe every gadget: (1) product code (procode) and (2) the standardized procode definition (product code - preferred time period). These two descriptive fields are meant to offer readability about which devices are tracked. The product code and preferred title are generally discovered within the approval or clearance letter issued by CDRH. FDA's steerage documents, iTagPro locator together with this steering, do not set up legally enforceable tasks. Instead, guidances describe the Agency's current pondering on a topic and should be considered solely as recommendations, until specific regulatory or statutory requirements are cited. The usage of the word should in Agency guidances means that one thing is urged or really helpful, but not required.
The invention pertains to a large-angle clever photo voltaic tracker, which features a moving platform and a set platform, and a primary branch chain I, a second branch chain II, a third department chain III, and a fourth branch chain are installed between the moving platform and the mounted platform. IV, the primary branch I and the third department III have the same construction and itagpro locator are symmetrically arranged, and the second department II and the fourth branch IV have the same construction and are symmetrically arranged; the primary branch I contains the first connecting rod, and iTagPro locator the first connecting rod The higher finish of the rod is connected with the transferring platform by the ball pair, itagpro locator the decrease finish of the primary connecting rod is related with the primary Hooke hinge, and itagpro locator the primary Hooke hinge is linked with the fastened platform by way of the primary connecting block by means of the primary moving pair; the second department chain II Including the second connecting rod, the upper end of the second connecting rod is linked with the moving platform by means of the second Hooke hinge, the decrease end of the second connecting rod is linked with the second connecting block by way of the rotating pair, and the second connecting block and the mounted platform are moved by way of the second Secondary connection.
The 4 department chains of the current invention form an area parallel closed-loop construction with the shifting platform and the mounted platform, which may realize two-dimensional translation and two-dimensional rotational motion in area. 本发明属于并联机器人领域,特别涉及一种应用于定位、气象、雷达等环境下能够实现精确跟踪的四自由度单平台大转角智能太阳追踪器。 The invention belongs to the sector of parallel robots, and specifically relates to a 4-diploma-of-freedom single-platform large-rotation-angle clever sun tracker that may notice exact tracking in environments equivalent to positioning, meteorology, and radar. 并联机构通常由动平台、静平台及两平台之间的若干支链组成,具有刚度大、速度快、精度高的优点,在工业机器人、运动模拟器、并联机床等领域得到广泛应用。
近些年,国外已将陆续将部分机构构型应用于工业生产中(如:delta机构),而国内则较少,而且很少应用在生产生活中。 The parallel mechanism is usually composed of a dynamic platform, a static platform and several branch chains between the two platforms. It has the advantages of high rigidity, fast pace and excessive precision. It is broadly utilized in industrial robots, iTagPro locator movement simulators, parallel machine instruments and different fields. In recent years, overseas countries have successively utilized some mechanism configurations to industrial manufacturing (similar to: delta mechanism), while there are fewer home ones, and ItagPro they're hardly ever utilized in production and life. 在运动模拟器、姿态调平、太阳能追踪以及并联机床等领域,通常需要实现大位移、大转角,实现较大工作空间范围内的运动。
Within the fields of motion simulators, perspective leveling, photo voltaic tracking, ItagPro and parallel machine tools, it is often mandatory to achieve giant displacements, large rotation angles, and motions within a big working house. 国内太阳能发电普遍采用固定式太阳能电池安装方式,尽管这种安装方式结构简单、成本较低,但是无法精确跟踪太阳位置,光能转换效率较低。 现有研究中,也存在部分运动型太阳能机构,单轴或双轴等多为串联机构精度不高。 其中双轴的跟踪精度相对较高,太阳板能达到的转换效率相对较大,但遇到恶劣天气难以保证装置的安全性。
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