T/CNMIA 0040-2023 The evaluation of efficacy and safety of home beauty devices for the human body

Scope

Scope: This document specifies the technical requirements and test methods for the evaluation of skin beauty devices for household and similar uses. This document is applicable to household and similar skin beauty devices with a rated voltage not exceeding 250 V and an output power of less than or equal to 100 W. Main technical content: Household beauty devices are a type of household appliance product that uses energy sources such as radio frequency, microcurrent, and LED light for skin care. These energies are the same as those used in medical skin treatment, but with lower power and higher safety, so they are generally regulated as non-medical devices in China and major developed countries in the West. According to recent medical literature worldwide, household beauty devices have begun to be used clinically to assist in the treatment of skin diseases and anti-aging care. At present, China does not have a special approval number or corresponding standards for household beauty devices, nor does it have clear naming regulations. However, an increasing number of household beauty devices are now being sold on the market and applied clinically. In order to provide consumers with more convenient and cost-effective skin care and anti-aging care effects, and to deliver excellent products with perceptible and evaluable results, it has become very important. Therefore, to promote the standardization of the industry and its continuous improvement and development, the Skin Professional Committee, in accordance with the requirements of the "China Non-Public Medical Institutions Association Group Standard Management Measures", has organized the work of formulating industry group standards for the human efficacy and safety evaluation of household beauty devices, in collaboration with authoritative professionals in the industry.

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