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欧洲激光皮肤科学会关于光基家用脱毛设备安全性的指南。

Guidelines on the safety of light-based home-use hair removal devices from the European Society for Laser Dermatology.

机构信息

Faculty of Applied Design & Engineering, University of Wales, Swansea Metropolitan University, Swansea, UK.

出版信息

J Eur Acad Dermatol Venereol. 2012 Jul;26(7):799-811. doi: 10.1111/j.1468-3083.2011.04406.x. Epub 2012 Jan 3.

Abstract

In the past 5 years since their US introduction, there has been a rapid proliferation of light-based hair removal devices intended for home-use. In the last 2 years in Europe, sales already run into many tens of thousands of units with well-known multi-national companies entering the market. These guidelines provide a definition of light-based home-use technology, to inform healthcare professionals about home-use light-based technology and encourage manufacturers wishing to sell in Europe to adopt 'best practice'. The review presents the current status on standards and regulation issues and considers home-use safety issues, encompassing human, device and electrical safety, given risks to the eyes and skin from optical radiation both to the consumer and persons in the vicinity. Proposed technical measurement methodology is considered with focus on recognized critical parameters for the safe use of light-based hair removal technology including recording the technical performance and safety claims of a range of home-use hair removal devices. The literature review emphasizes potential adverse incidents and safety aspects of treating cosmetic conditions, such as unwanted hair growth. Although some regulations exist, they differ from region to region and there is a specific need for international common principles and guidelines relating to the manufacture, marketing and use of intense pulsed light and laser devices, including manufacturing standards for home-use products intended, amongst others, for cosmetic hair removal and photo-rejuvenation procedures. In these guidelines, the European Society for Laser Dermatology (ESLD) provides a professional view of what 'best practice' may imply for manufacturers and consumers alike.

摘要

在过去的 5 年中,自它们在美国推出以来,旨在供家庭使用的基于光的脱毛设备迅速普及。在过去的 2 年中,在欧洲,已经销售了成千上万台知名跨国公司的产品,销售额已达数万。这些准则提供了家用基于光的技术的定义,旨在告知医疗保健专业人员有关家用基于光的技术,并鼓励希望在欧洲销售的制造商采用“最佳实践”。该综述介绍了当前的标准和法规问题的现状,并考虑了家用安全性问题,包括来自光学辐射对消费者和周围人员的眼睛和皮肤的风险,涵盖了人类,设备和电气安全性。考虑了家用脱毛技术安全使用的公认关键参数的建议技术测量方法,包括记录一系列家用脱毛设备的技术性能和安全要求。文献综述强调了治疗美容状况(例如,不必要的毛发生长)的潜在不良事件和安全性方面。尽管存在一些法规,但它们因地区而异,因此需要制定有关强光脉冲和激光设备的制造,营销和使用的国际通用原则和准则,包括家用产品的制造标准,这些产品除其他外,用于美容脱毛和光老化程序。在这些准则中,欧洲激光皮肤科学会(ESLD)为制造商和消费者提供了“最佳实践”可能意味着什么的专业观点。

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