摘要: Ultrasonic dental scaler超声波洁牙机 FDA CFR - Code of Federal Regulations Title 21 PART 872 -- DENTAL DEVICES Subpart E - Surgical Devices Sec. 872.4850 Ultrasonic scaler. (a) Identification. An u ...
Ultrasonic dental scaler超声波洁牙机 FDA CFR - Code of Federal Regulations Title 21 PART 872 -- DENTAL DEVICES Subpart E - Surgical Devices Sec. 872.4850 Ultrasonic scaler. (a) Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth. (b) Classification. Class II.
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工程师具有15年以上的EMC行业从业经验，处理过各类数字模拟复杂高集成度电路经验，不限于几十千伏高压放电与微小人体生理信号。成功处理过笔记本电脑、红外热像仪、脑电心电、血液透析、导航与各类家电等经验。
罗德与施瓦茨公司、是德/安捷伦、EMTest、ETS-Lindgren、泰克及整改用到的各类辅助设备，不限于近场探头、示波器、电桥等仪器设备。现场，还拥有各类EMC物料不限于、磁环、滤波器、电容、电阻、电感、磁珠、铜箔、导电布等。
我们相信您一定遇到过这样、那样的电磁干扰、抗干扰的问题，一筹莫展，找不到骚扰根源、或找不到敏感电路、信号，延误产品上市周期，这时您可以选择我们，我们可以为您提供清晰的解惑与悉心指导，不仅仅是解决问题，还授人以渔。
我们不仅仅仅有EMC测试、EMC整改服务、还有各类EMC器件，可以提供各类EMC合格方案，还具备全球各地区的认证，不限于电磁兼容、安规、无线射频、可靠性与偏门测试等标准法规，甚至定制化测试与验证，可为企业提供一站式服务。
Non-clinical Testing:
The functions of TTBIO EVOCLEAN Ultrasonic Scaler were verified according to ISO18397:2016.
Cleaning validation testing is performed in accordance with recommended evaluations as listed in AAMI TIR30, AAMI TIR12, and Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings.
The biocompatibility evaluation for TTBIO EVOCLEAN Ultrasonic Scaler was conducted in accordance with Guidance for Industry and FDA Staff – Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”.
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA’s Guidance for Industry and FDA Staff, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”.
EMC and Electrical safety testing comply with IEC 60601-1-2:2014 and ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012.
Clinical Testing:
No clinical testing was conducted for this submission.
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