关键词: 单晶硅纳米微针, 医疗美容, 创伤性, 侵入性

Abstract:

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.

Key words: monocrystalline silicon nano-microneedles, medical beauty, traumatic, invasiveness