淘乐棋牌官方网站

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                          • I类设备ce认证过渡期欧盟MDR延迟到2024年5月26日

                            淘乐棋牌官方网站KEZHONGFUSHIYONGDEILEIYILIAOSHEBEIHEILEIRUANJIANDEZHIZAOSHANGJIANGGENJUOUMENGJIJIANGSHISHIDE《YILIAOSHEBEIFAGUI》JINXINGFENLEI,GENJUDUIOUMENGMDRTICHUDEXIUZHENGAN,TAMENJIANGYOUGENGDUODESHIJIANLAIZUNSHOUXINGUIZE,YIQUEBAOZHIDINGJIGOUDUISHEBEIJINXINGSHENCHABINGZAI2020NIAN5YUE26RIZHIQIANWANCHENGHEGEPINGDING。     ILEIYILIAOQIXIEZHONGDESANGEBUTONGZUJIANGZAIYOUSINIANSHIJIANCAINENGFUHEXINFAGUI,WANQUANFUHEDANGQIANYILIAOQIXIEZHILING(MDD)DEQIXIEKENENGSHI(1)KEZHONGFUSHIYONGDESHOUSHUQIXIE,(2)ZAIWUJUNTIAOJIANXIAHUO(3)JUYOUCELIANGGONGNENG,KENENGHUIBAOLIUHUOTOUFANGSHICHANG,ZHIDAO5YUE26RI,2024NIAN。YANCHIJIANGSHIZHEIXIESHEBEIDEZHIZAOSHANGYOUGENGDUOSHIJIANZHUNBEIQI...

                            标准法规 2019-03-23 6 0
                          • 欧盟MDR临床评价报告编写的三条建议

                            淘乐棋牌官方网站      LINCHUANGPINGGUBAOGAO(CER)SHIYIXIANGZHONGYAODEJISHUWENJIAN,YILIAOSHEBEIXUYAOCERENZHENGBIAOJI,YINCIZAIOUZHOUXIAOSHOU。GENJUXINDEOUMENGYILIAOQIXIEFAGUI(MDR),GAIFAGUIYU2020NIAN5YUESHENGXIAO,DUICERDEZHONGSHIDADAZENGJIA。YINCI,MEIYOUXINGONGYIJINGYANDEYILIAOQIXIEGONGSIKENENGHUIFAXIANCERXIEZUOYIGEJUYOUTIAOZHANXINGDEGUOCHENG。      SUOYOUYIJINGSHANGSHIDEYILIAOSHEBEIDOUXUYAOZHONGXINRENZHENG,YINCIWEIMDRZUOHAOZHUNBEISHIYIXIANGJIANJUDERENWU。TABAOKUOPINGGUNINDECHANPINYIJIANCHASHIFOUFUHEYAOQIU,TONGSHISHOUJIJISHUWENJIANSUOXUDESUOYOUXIANGGUANJISHUWENDANG。CERSHIYILIAOSHEBEIJISHUWENJIANDEZHONGYAOZU...

                            标准法规 2019-03-23 9 0
                          • 修订后的欧盟电动玩具标准EN IEC 62115发布

                            CENELECZAI2YUE21RIFABULEDIANDONGWANJUBIAOZHUNEN IEC 62115:2020HEA11:2020,GAIBIAOZHUNJIANGHENKUAIYUCENELECBIAOZHUNZUZHIYIQICHUSHOU。EN IEC 62115:2020SHIGUOJIIEC 62115:2017DIANDONGWANJUBIAOZHUNDEOUZHOUBANBEN。CONGJISHUSHANGJIANG,ZHEIXIEBIAOZHUNSHIXIANGTONGDE,YINWEIQIMUBIAOSHISHIXIANQUANQIUFANWEIDEXIEDIAO。WEILEFUHEOUZHOUWANJUANQUANZHILING2009/48 / ECDEMOUXIEZHENGSHIYAOQIU,XUYAOFABUDANDUDEOUZHOUBIAOZHUN。ZHEIXIETEDINGDEOUZHOUYAOQIUBAOHANZAIDANDUDEXIUDINGZHONG– EN IEC 62115:2020:A11:2020。DANDUDEXIUZHENGANBAOKUO:1.YINYONGQITAXIANGGUANDEOUZHOU...

                            标准法规 2019-03-20 30 0
                          • ECHA将邻苯二甲酸盐列入REACH认证授权清单

                            淘乐棋牌官方网站      EFSAFABULEWUZHONGSHOUQUANYONGYUSHIPINJIECHUSULIAODELINBENERJIASUANYANDEZUIXINFENGXIANPINGGU,LINBENERJIASUANERHUANJIJIZHI(DCHP)SHIOUZHOUHUAXUEPINGUANLIJU(ECHA)ZHENGZAIKAOLVJIANYILIERUREACHSHOUQUANQINGDAN(FUJIANXIV)DEWUZHIZHIYI。      ECHAZAI3YUE5RIDEXINWENGAOZHONGZHICHU,DCHP(YONGZUOZENGSUJI)YINGJUYOUQIANZAIDEDUXING,YINWEITAJUYOUZHONGSUDUXINGHEPOHUAINEIFENMIDETEXING。JINGUANZAI2019NIAN10YUEJINXINGDEYICISHIPINJIECHUCAILIAOZHONGLINBENERJIASUANYANDESHIYONGDIAOCHAZHONG,WEIYITIJIDCHPDEDIFANGSHITAKENENGYONGZAI2007/42HAOZHILINGSHOUQUANDEMOU...

                            REACH认证 2019-03-20 30 0
                          • 欧盟废物框架指令管理EU WFD的数据要求

                            淘乐棋牌官方网站OUMENG(EU)FEIWUKUANGJIAZHILING(WFD)YU2018NIANJINXINGLEXIUDING,YINRULEDUIYOUOUZHOUHUAXUEPINGUANLIJU(ECHA)GUANLIDEWUPINHECHANPINZHONGGAODUGUANZHUWUZHI(SVHC)JIZHONGSHUJUKUDEQIANGZHIXINGYAOQIU。GAISHUJUKU,JI“ WUPINZHONGSHEJIDEWUZHI”HUO“FUZADUIXIANG(CHANPIN)(SCIP)”SHUJUKU,ZHIZAISHISVHCXINXIZAIWUPINHECAILIAODEZHENGGESHENGMINGZHOUQIZHONGKEYONG。ZHIBANRENYUANBIXUZAI2021NIAN1YUE5RIZHIQIANTIJIAOCIXINXI。JUJIEZHIRIQIBUDAOYINIANDESHIJIAN,CHENGDANSCIPSHUJUKUBAOGAOYIWUDEZHIZAOSHANGZHENGZAINULISHOUJISHIDANGDESHUJU,YIQUEBAOTAMENJIANGSUOYOUZHENGQUEDEXINXITIJIAOJIWANCHENGDESHUJUKU。YUECHAJIAOLIUDEGUANJIANXINXI《HUAXUEPINZHUCE,PINGGU,SHOUQUANHEXIAN...

                            标准法规 2019-03-20 24 0
                          • 医疗器械法规MDR受英国脱欧和疫情影响或延迟

                            淘乐棋牌官方网站      2020 NIAN3YUE13 RI,OUZHOUYILIAOQIXIEXIEDIAOXIAOZU(MDCG)FABULEYOUGUANXINYILIAOQIXIEFAGUI(EU)2017/745(MDR)DELIANHESHISHI/ZHUNBEIJIHUA。GAIJIHUASHIYOUOUZHOUWEIYUANHUIYUCHENGYUANGUOGONGTONGZHIDINGDE,DANTAHUYUSUOYOUXIANGGUANLIYIFANGJINYIBUJIAJINNULI,GONGTONGNULI,YIZAI2020NIAN5YUEZHIQIANSHIXIANYIGEYUNYINGXITONG。GAIJIHUAZHIZAIQUEDINGYOUXIANSHIXIANGBINGTIGONGSHOUDUANZHEIYANGZUO。  GAIJIHUASHIZAI2019 NIAN12YUE9 RIOUZHOULISHIHUIYAOQIUWEISHENGBUZHANGYAOQIUZHUNBEIJIUXUDEHUYUYIJI2019NIAN12YUE13 RI MDCGHUIYIDEJIEGUOZHIHOUQICAODE,MDCGCHENGYUANXI...

                            标准法规 2019-03-19 24 0
                          • 医疗器械CE-MDD认证2020年5月26正式申请日期

                            淘乐棋牌官方网站YILIAOQIXIEGUANLIJIQIDUIYILIAOQIXIEZHIZAOSHANGDEYINGXIANGZAIOUZHOULIANMENG(OUMENG)NEI,CONG“YILIAOSHEBEIZHILING”(MDD)XIANG“YILIAOSHEBEITIAOLI”(MDR)DEGUODUZHENGZAIJINZHANDAOOUMENGGONGBUDEZUICHUSHIJIANBIAO。SUIZHEYILIAOSHEBEIZHIZAOSHANGHEBEITONGZHIJIGOUKAISHIDUIXINZHILINGDESUOYOUJISHUWENJIANJINXINGSHENCHA,XINGUIDINGLINGRENDANXINDEZHENGSHUJIYAXIANXIANGKAISHIXIANXIAN。GUODUGUOCHENGDUIZHIZAOSHANGDESHIJIYINGXIANGZHENGBIANDEYUELAIYUEQINGCHU,BENWENDEMUDESHIZONGSHUSHIYONGYUYIBANYILIAOSHEBEI,TEBIESHIZHUANYEYINXINGYANJING(CL‘s)HERENGONGJINGZHUANGTI(IOL’s)DEXIANZHUANG。ZHONGYAODESHIYAOMINGQUEMDRJIESHAODESHIJIANBIAO,SHENGXIADELIANGGEGUANJIANRIQISHI:     2020NIAN5YUE26RI...

                            标准法规 2019-03-18 78 0
                          • 新的医疗器械MDR法规结构如何,如何影响CE认证?

                            1.WEISHENMEMDDXUYAOGENGXIN?XUYAOGENGXINMDDYOUXUDUOYUANYIN,LIRUYIJIUJIUERNIANMDDSHENGXIAODESHIHOU,YILIAOSHEBEIRUANJIAN(SaMD)HAIBUCUNZAI。RUANJIANSHIYIZHONGKEYIKONGZHIDIANJIDEDONGXI,ERQIEMEIYOURENHEYINGYONGCHENGXUKEYIYONGLAIJIANKONGBINGRENZIJIDEJIANKANGZHUANGKUANG。ZI1992NIANYILAI,SUIZHERENKOULAOLINGHUA,OUZHOUDERENKOUJIEGOUYEFASHENGLEBIANHUA,DUIGONGZHONGDEYILIAOSHEBEIJISHUXINXITOUMINGDUDEYAOQIUYEYUELAIYUEGAO。ZHEIXIEYINSUJIAZAIYIQI,SHIMDDBEIYIXIANGXINZHILINGQUDAIDEYUANYINZHIYI,GAIZHILINGJIANGGULIZHENGGEOUZHOUGENGGUANGFANDIZUNSHOUBIAOZHUNHUAYILIAOSHEBEITIAOLI。 2.XINMDRDEJIEGOURUHE?      XINDEMDRWENDANGZHANGDA174YE...

                            标准法规 2019-03-18 23 0
                          • 如何遵守欧盟2020年医疗器械MDR法规

                            OUMENG2020NIANMDRDEXINGUIDINGDUINIYIWEIZHESHENME?      QUEBAOZUNSHOUOUMENGYILIAOQIXIETIAOLI(OUMENGMDR)DEZUIHOUQIXIANJIJIANGDAOLAI。ZHEIXIEXINGUIDINGZHIZAIGAISHANOUMENGNEIXIAOSHOUDEYILIAOQIXIEDEKEZHUISUXING、TEZHENGHEANQUANGUANLI。JULIZUIHOUQIXIANHAIBUDAOJIUGEYUE,YILIAOSHEBEIZHIZAOSHANGYIJINGKAISHIDAOJISHI,YIQUEBAOTAMENZUNSHOUGUIDING。OUMENGDUIMDRDEYAOQIUSHISHENME?      OUMENGMDRJIANGYU2020NIAN5YUE26RISHENGXIAO,QUDAIOUMENGXIANXING“YILIAOQIXIEZHILING”(93/42/EEC)HE“KEZHIRUSHIYOUYUANYILIAOQIXIEZHILING”(90/385/EEC)。ZAIOUMENGNEIXIAOSHOUDEYILIAOQI...

                            标准法规 2019-03-18 30 0
                          • 新欧洲医疗器械法规MDR和IVDR中要理解的8个关键更改

                                  XINDEMDRHEIVDRFAGUIYU2017NIAN3YUEHUODELEOUZHOULISHIHUIDEPIZHUN,BINGYU2017NIAN4YUEHUODELEOUZHOUYIHUIDEPIZHUN。LIANGXIANGFAGUIYU2017NIAN5YUE26RISHENGXIAO; XINGUIZEJIANGYU2020NIAN5YUE26RIKAISHISHIYONGYUMDR,2022NIAN5YUE26RIKAISHISHIYONGYUIVDR。      XINFAGUIZHIZAITIGAOOUMENGSHICHANGZHONGYILIAOQIXIEDEANQUANXINGHEYOUXIAOXING,TONGSHIJIEJUEYIXIEYILIAOQIXIEZHIZAOSHANGZAISHISHIYILIAOQIXIEZHILINGZHONGFAXIANDERUODIAN。MDRHEIVDRYESHIDUIXUNSUSUZAOYILIAOQIXIEXINGYEDEJISHUHEKEXUEFAZHANDEHUIYING。GAIFAGUIJUYOUJIXIANGZHONGDAGENGGAI,JINGUANXUDUO...

                            标准法规 2019-03-18 39 0
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