Discussion on Safety Classification of Medical Laser Equipment
SHEN Gao1, LIU Yan-zhen2, HE Wei-gang1, REN Hai-ping2
1.Center for Medical Device Evaluation, CFDA, Beijing 100044, China;2.Institute for Medical Devices Control, National Institutes for Food and Drug Control, Beijing 100050, China
Abstract:The standard GB7247.1-2012 Safety of laser products-Part 1: Equipment classification and requirements, which specifies the methods to classify laser products has been promulgated and implemented. Almost all the medical laser equipment need to reference the standard and the classification of product management categories is also based on this standard. Taking 1470 nm laser system as an example, the categories of products can be determined by calculating pulse duration which can match accessible emission limit (AEL). It provides a new thinking angle for testing institutions and production enterprises to preliminary judge the categories of products.
申高, 刘艳珍,贺伟罡,任海萍. 医用激光设备安全分类的探讨[J]. 中国医疗设备, 2014, 29(8): 82-84.
SHEN Gao, LIU Yan-zhen, HE Wei-gang, REN Hai-ping. Discussion on Safety Classification of Medical Laser Equipment. China Medical Devices, 2014, 29(8): 82-84.