規(guī)格參數(shù)
93/42/EEC (歐盟針對(duì)醫(yī)療器械的法規(guī)要求)
89/686/EEC (歐盟針對(duì)個(gè)人防護(hù)設(shè)備的法規(guī)要求) ISO
14971 (風(fēng)險(xiǎn)管理體系) IEC 60601 (國家電工委員會(huì)針對(duì)醫(yī)用電氣設(shè)備標(biāo)準(zhǔn))
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