眠呼吸监测产品技术审评规范(2010版)（Specification for technical review of respiratory monitoring products (2010 Edition)）.docVIP

眠呼吸监测产品技术审评规范(2010版)（Specification for technical review of respiratory monitoring products (2010 Edition)） Specification for technical review of sleep apnea monitoring products (2010 Edition) (Draft for comment) According to the medical device registration (the State Food and Drug Administration Decree No. sixteenth) requirements and the characteristics of sleep apnea monitoring products, for technical evaluation standard sleep apnea monitoring products, formulated norms. I. scope of application This specification applies to sleep breathing monitoring products. In the classified catalogue of medical devices, the management category is II, and the product class code is 6821-9. Two, technical review points (1) product name requirements; In this standard, sleep breathing monitoring products are classified into 3 grades (see Table 1): Class A, class B, and class C. A product should be named as sleep products, B products should be named as sleep apnea products, C products should be named as sleep apnea screening products, function less than C class products cannot be named as sleep and sleep or sleep apnea screening products. In addition, if the product does not have real-time monitoring function, but can only be used for collection, recording and analysis, the product can only be named recording products, and can not be named monitoring products, but the products are also applicable to this specification. For the record product, it must have a matching analysis software to be registered. In the above principle on the basis of the product name should reflect the product features or physical properties, such as polysomnography (Table 1 in Grade A), sleep monitor (B grade 1 in the table), sleep apnea screening instrument (Table 1 in C). At the same time, in order to facilitate management, product name, as far as possible in the catalog of the National Bureau of pharmacy product name. Table 1 Classification of sleep breathing monitoring products Implementation function A B