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作 者:隋建坤 朱学军 张建永 SUI Jiankun;ZHU Xuejun;ZHANG Jianyong
机构地区:[1]北京市朝阳区卫生健康监督所,北京100020
出 处:《中国科技术语》2025年第2期118-121,共4页CHINA TERMINOLOGY
摘 要:文章旨在探讨单晶硅纳米微针在医疗美容领域中的法律地位,重点分析其是否符合现行法律对“创伤性”和“侵入性”的定义,为相关法律法规的制定和实施提供实证支持,从而推动医疗美容领域的规范化发展。通过详细审视单晶硅纳米微针的技术特征和操作过程,发现该微针通过微小的穿刺形成皮肤通道,显著具备创伤性和侵入性特征。这一发现与医疗美容行为的标准定义相符合。与电外科治疗和微波治疗等技术相比,单晶硅纳米微针的操作过程直接破坏皮肤结构,表现出更明显的物理侵入性。结合《微针治疗操作规范》团体标准的相关规定,建议明确将单晶硅纳米微针归类为医疗美容行为,以便在法律框架内进行有效监管,从而保护消费者的健康权益。The purpose of this paper is to discuss the legal status of monocrystalline silicon nano-microneedles in the field of medical beauty,focus on analyzing whether they conform to the definitions of “traumatic” and “invasive” in current laws,provide empirical support for the formulation and implementation of relevant laws and regulations,and promote the standardization and healthy development of medical beauty field.By examining the technical characteristics and operation process of monocrystalline silicon nano-microneedles in detail,it is found that the microneedles form skin channels through tiny puncture,which is obviously traumatic and invasive.This finding is consistent with the standard definition of medical beauty behavior.Compared with electrosurgical treatment and microwave treatment,the operation process of monocrystalline silicon nano-microneedles directly destroys the skin structure and shows more obvious physical invasion.Combined with the relevant provisions of the group standard of “Code of Practice for Micro-needle Therapy”,this paper suggests that monocrystalline silicon nano-needles should be clearly classified as medical beauty behavior,so as to carry out effective supervision within the legal framework and protect the health rights and interests of consumers.
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