心電監(jiān)護(hù)儀GB9706.1-2007醫(yī)療器械CMA報告

業(yè)務(wù)范圍：
1、受理醫(yī)療器械、高端裝備制造、新能源汽車、動力與儲能電池、電子、電器、燈具、通訊設(shè)備、太陽能光伏組件、汽車電子等產(chǎn)品的安全試驗，電磁兼容（EMC）測試，軟件評測等領(lǐng)域，有毒有害物質(zhì)檢測（ROSH）、環(huán)境與可靠性試驗、能效檢測等委托檢測業(yè)務(wù)，以及相關(guān)產(chǎn)品的進(jìn)出口檢測和驗貨檢驗業(yè)務(wù)；
2、承擔(dān)國家強(qiáng)制性產(chǎn)品認(rèn)證(3C)檢測和CQC自愿性產(chǎn)品認(rèn)證檢測任務(wù)；
3、承擔(dān)國家與地方政府主管部門下達(dá)的相關(guān)產(chǎn)品的質(zhì)量監(jiān)督檢驗和科技成果鑒定；
4、承接CE、CB、FCC、VCCI、PSE、UL、ETL、MET、E-Mark、FDA、C-Tick、TUV、NEMKO、GCF、CDG、SASO、PTCRB、CEC、MEPS、VDE等國際認(rèn)證檢測、培訓(xùn)業(yè)務(wù)；
5、提供相關(guān)產(chǎn)品的檢驗技術(shù)、檢驗方法及質(zhì)量管理等方面的培訓(xùn)業(yè)務(wù)；
6、開展有關(guān)新的檢測技術(shù)、檢測方法的研究和產(chǎn)品標(biāo)準(zhǔn)的制訂。

醫(yī)療器械注冊檢驗中檢南方唐小姐（國家級CMA實驗室)
01激光治療設(shè)備
IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN60601-2-22(要滿足iec60825)，GB9706.222(要滿足iec60825或GB7247.1）gb/t14710
02光動力激光治療設(shè)備
IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN60601-2-22(要滿足iec60825)，GB9706.222(要滿足iec60825或GB7247.1）gb/t14710
03光動力治療設(shè)備
IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN60601-2-57(要滿足iec62471)，GB9706.257(要滿足iec62471或GB/T 20145）gb/t14710
04強(qiáng)脈沖光治療設(shè)備
IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN60601-2-57(要滿足iec62471)，GB9706.257(要滿足iec62471或GB/T 20145）gb/t14710注：如果是家用設(shè)備，IEC/EN60601-2-57更換為IEC/EN60601-2-83，GB9706.257更換為GB9706.283
05紅光治療設(shè)備
IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN60601-2-57(要滿足iec62471)，GB9706.257(要滿足iec62471或GB/T 20145）gb/t14710注：如果是家用設(shè)備，IEC/EN60601-2-57更換為IEC/EN60601-2-83，GB9706.257更換為GB9706.283
06藍(lán)光治療設(shè)備
IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN60601-2-57(要滿足iec62471)，GB9706.257(要滿足iec62471或GB/T 20145）gb/t14710注：如果是家用設(shè)備，IEC/EN60601-2-57更換為IEC/EN60601-2-83，GB9706.257更換為GB9706.283

樣本分離設(shè)備
01醫(yī)用離心機(jī) IEC/EN61010-1,GB4793.1IEC61010-2-101,YY0648IEC61010-2-081,GB4793.9gb/t14710IEC/EN61326-1,GB/T18268.1IEC/EN61326-2-6,,GB/T18268.26注：如帶加熱部件，需增加IEC/EN61010-2-010,GB4793.6
02核酸提取純化儀 IEC/EN61010-1,GB4793.1IEC61010-2-101,YY0648IEC61010-2-081,GB4793.9gb/t14710IEC/EN61326-1,GB/T18268.1IEC/EN61326-2-6,,GB/T18268.26注：如帶加熱部件，需增加IEC/EN61010-2-010,GB4793.6

高頻治療設(shè)備
01 射頻熱療設(shè)備 IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN60601-2-2,GB9706.202IEC60601-1-11,YY9706.111（如果宣稱家用）gb/t14710
02 射頻淺表治療設(shè)備 IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN60601-2-2,GB9706.202IEC60601-1-11,YY9706.111（如果宣稱家用）gb/t14710
03 微波治療設(shè)備 IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC60601-1-11,YY9706.111（如果宣稱家用）gb/t14710

血管內(nèi)輸液器械
01輸液泵 IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102IEC/EN80601-2-24,YY9706.224gb/t14710

溫?zé)幔ɡ洌┲委熢O(shè)備/器具
01 熱傳導(dǎo)治療設(shè)備(醫(yī)用電熱毯,褥和墊） IEC/EN60601-1，GB9706.1,IEC/EN60601-1-6,YY/T9706.106,IEC/EN60601-1-2，YY/T9706.102,IEC/EN80601-2-35,YY9706.235gb/t14710
02 熱輻射治療設(shè)備IEC/EN60601-1，GB9706.1IEC/EN60601-1-6,YY/T9706.106IEC/EN60601-1-2，YY/T9706.102YY0306，YY0323(只適合紅外）gb/t14710