Discussion on the decision and evaluation requirements of animal experiment of medical laser equipment
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Affiliation:

1. Center for Medical Device Evaluation. NMPA, Beijing 100081, China. 2. Laboratory Animal Research Center/ Institute of Comparative Medicine, Hangzhou 310053

Clc Number:

R-33

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    Abstract:

    Medical laser equipment is an electrical equipment that outputs energy to human target tissues. Animal experiment is one of the important method for preclinical / clinical evaluation of laser equipment, and it can also be used as evidence of safety and effectiveness of such equipment before clinical trials. This article analyzes the mechanism of action of medical laser equipment by referring to existing regulations, standards, and guidelines related to animal experiment of medical equipment. Based on the evaluation experience of common laser therapy equipment, the factors and standard requirements for the decision making of animal experiments with laser therapy equipment were summarized. In addition, design requirements and evaluation indexes of animal tests were analyzed with examples. The purpose of this paper is to provide a reference for the animal experimental study of medical laser therapy equipment, as well as for the technical reviewers and registrants related to this medical device.

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History
  • Received:November 29,2021
  • Revised:
  • Adopted:
  • Online: August 01,2022
  • Published: