（醫(yī)療質(zhì)量及標(biāo)準(zhǔn)）醫(yī)療器械注冊產(chǎn)品標(biāo)準(zhǔn)高頻電刀

2004-05-19發(fā)布2004-05-19實 日本MDMMDM20040510

GB191-2000GB/T16886.10:200010GB9706.1-19951防電擊類型：I防電擊保護類型：BF主機尺寸（長×寬×高刀頭,環(huán)形刀頭,鐮型刀頭,球型刀頭,撓性內(nèi)窺鏡電極尺寸（mm）,ф3,ф5,R1.5,R2,ф1,ф2,ф1,ф1.4環(huán)境溫度相對濕度大氣壓力0-49W1W，實測值與設(shè)定值之差不超過環(huán)氧乙烷殘留量應(yīng)GB9706.1GB9706.4A（規(guī)范性附錄..64.3.6GB/T14233.14.4GB/T16886.10-20004.5.1GB/T16886.10-20004.5.2GB14233.2-1998GB/T144.6A（規(guī)范性附錄6.1A1產(chǎn)品特征a）電刀所屬的類：I

附錄主要輸送周波數(shù)最大輸出A2.1A2.1.1工作頻率或頻率(基頻或頻率額定值)(MHzA2.1.2A2.2A2.2.1GB9706.1－19956.2A2.3A2.3.1GB9706.1－19956.3GB9706.4－19996.3A2.4A2.4.1A2.4.2A2.5A2.5.1GB9706.1－19956.5A2.5.2A2.6A2.8A2.8.1A2.8.2A2.9.1A2.9.2A2.10.1GB9706.1－19956.8.1A2.11A2.11.1GB9706.1－19956.8.2a)GB970d)GB970aa)A2.12A2.12.1GB9706.1-19956.8.3GB9706.4－1999A2.12.2A2.13.1A2.13.2A2.14ｂ）10%～100%；A2.14.2ｄ）輸入電源A2.14.3A2.15A2.15.1IBFA2.15.2A2.16A2.16.2A2.18A2.18.2A2.19A2.21A2.22A2.24A2.25A2.26GB9706.1-199517a)4)A2.26.2A2.28A2.29.1GB9706.1-199517g)A2.29.2A2.30A2.31.1A2.31.2A2.32A2.33A2.34A1對地漏電流,0.5,1外殼漏電流,0.1,患者漏電流,0.1,5A2.34.2A2.35A2.36A2.36.150Hz、1000V1min,無擊穿或閃絡(luò)的現(xiàn)象.1在應(yīng)用部分和帶電部分之間(B-a),50Hz、3000VA2.36.2A2.37A2.34.1A2.37.2GB9706.1-19954.10GB97.06.1-199519.1A2.39A2.39.1A2.39.2GB9706.1-19954.10GB9706.1-199520.4A2.40A2.40.2試驗方法A2.41A2.41.1A2.41.2A2.42A2.44A2.44.1A2.44.2A2.45A2.45.1GB9706.1-199521.6A2.45.2A2.46A2.47A2.48A2.49A2.51A2.52A2.52.1A2.52.2A2.53.1A2.53.2試驗方法A2.55A2.56A2.57A2.59A2.61APGAPA2.63A2.66A2.67APA2.69A2.69.1GB9706.1-199542.142.2A2.69.2A2.70A2.71.1A2.71.2A2.72A2.73GB9706.1-199544.5A2.73.2A2.74A2.74.1GB9706.144.6GB9706.4-199944.6A2.74.2A2.75A2.75.1A2.75.2A2.76A2.77A2.78A2.80A2.80.1GB9706.1-199549.2GB9706.4-199951.101A2.80.2A2.82A2.82.1GB9706.1-199551GB9706.4-199951A2.83A2.83.1A2.83.2A2.84A2.84.1GB9706.1-199552.5.4、52.5.5、52.5.9GB9706.43.6A2.84.2A2.85A2.85.1GB9706.1-199556.1b)A2.85.2A2.86.1GB9706.1-199556.1d)A2.86.2A2.87A2.87.1A2.87.2A2.88.1A2.88.2（漏電流超過正常狀態(tài)時的值、溫度等A2.89.1A2.89.2A2.90A2.90.2A2.91A2.91.1A2.91.2A2.92A2.92.1A2.29.2A2.93A2.94A2.94.1A2.94.2A2.95.1GB9706.116c)A2.95.2A2.96.1A2.96.2GB9706.4－199956.11b)A2.97.1A2.97.2A2.99A2.99.1A2.99.2A2.100A2.101A2.102A2.102.1A2.102.2A2.103A2.103.1A2.103.2A2.104A2.104.1A2.104.2A2.105A2.105.1A2.105.2A2.106A2.106.1A2.106.2A2.107A2.107.1GB9706.159.1A2.107.2A2.108A2.108.1A2.108.2A2.109A2.109.1A2.109..2A2.111A2.111.1GB9706.4－199950.1A2.112A2.112.1GB9706.4－1999101.2A2.113A2.113.1GB9706.4－1999101.3A2.114A2.114.1GB9706.4－1999101.5A2.115A2.115.1GB9706.4－199956.11A2.116A2.116.1GB9706.4-199946.101A2.116.2GB9706.4-199946.101AGB191-2000GB/T16886.10:200010G