亚洲精品中文字幕乱码三区,51精品国产人成在线观看,精品视频一区二区三区在线观看,少妇夹得好紧太爽了a片

ANVISA更新INMETRO認(rèn)證所要求的技術(shù)標(biāo)準(zhǔn)清單

發(fā)布時間:2014-10-13


September 30, 2015 by Stewart Eisenhart Brazilian medical device marketregulator ANVISA has published a new list of technical standards to which someelectrical medical devices and IVDs must comply in order to obtain INMETROcertification in the country.


巴西醫(yī)療器械上市監(jiān)管機構(gòu)ANVISA已經(jīng)出版了一個新的技術(shù)標(biāo)準(zhǔn)清單,一些電氣醫(yī)療器械和IVD器械必須遵循這些標(biāo)準(zhǔn)以獲得INMETRO證書。


The new ANVISA normativeinstruction, IN 04/2015, replaces IN 11/2014, andupdates compliance timeframes for various IEC 60601 standards. Two majorupdates are included in the new instruction.


新的ANVISA規(guī)范性指南,IN 04/2015,代替IN 11/2014,更新了IEC 60601系列標(biāo)準(zhǔn)的符合性框架。新的規(guī)范性指南包含了兩個主要的更新。


First, ANVISA has removed INMETROcertification requirements for IVD products; specifically, IVDs have beenexempted from complying with IEC 61010-2-101:2002 (safety requirements forelectrical equipment for measurement, control and laboratory use) and with ISO15197:2013 (requirements for blood glucose monitoring systems designed forself-testing).


首先,ANVISA去掉了IVD產(chǎn)品對INMETRO證書的要求;尤其是,IVD產(chǎn)品已經(jīng)豁免了IEC 61010-2-101:2002和ISO15197:2013的要求。


Second, the new instruction haspushed back compliance dates for some standards that Brazilian testing labs donot yet have the capacity to monitor. For example, although IEC 60601 3rdEdition series testing is now mandatory for INMETRO certification, testing labs in Brazil are not yet able to test according to some 3rd editionstandards. In the meantime,manufacturers may submit test reports showing compliance with earlier versions of the 60601 standard in order to obtain theirINMETRO certifications.


其次,新指南回調(diào)了一些巴西實驗尚無能力監(jiān)測的標(biāo)準(zhǔn)的符合性日期。例如,雖然IEC60601第3版系列測試對于INMETRO是強制的,巴西的實驗室還不能根據(jù)這些第3版標(biāo)準(zhǔn)進(jìn)行測試。同時,制造商可以提交證實已符合早期版本的60601標(biāo)準(zhǔn)以獲得其INMETRO認(rèn)證。

 

關(guān)于卓遠(yuǎn)天成:

深圳市卓遠(yuǎn)天成咨詢有限公司是一家從事醫(yī)療器械國際咨詢的專業(yè)性咨詢機構(gòu),可為您提供各個國家或地區(qū)醫(yī)療器械上市注冊、醫(yī)療器械質(zhì)量體系審查等多種國際注冊及認(rèn)證的咨詢/代理服務(wù)。

端庄美艳人妻教师的沉沦| 小雪被老汉各种姿势玩弄| 久久国产avjust麻豆| 色哟哟网站在线观看| 蜜臀av夜夜澡人人爽人人| 久久精品人妻一区二区三区| 亚洲AV乱码一区二区三区林ゆな| 国产女人18毛片水真多1| 亚洲一区二区三区无码久久| japanese50mature日本亂倫| 又色又爽又高潮免费视频观看 | 国产成人无码专区| 在厨房抱住岳丰满大屁股| 无码国产精品一区二区高潮| 国产深夜男女无套内射| 久久久无码人妻精品无码| 特黄aaaaaaa片免费视频| 国产成人无码精品久久久露脸 | 女女女女bbbbbb毛片在线| 无码av免费毛片一区二区| chinese猛男自慰gv网站| 国产av一区二区三区传媒| 欧美老熟妇乱大交xxxxx| 中文字幕乱码人妻二区三区| 欧美老熟妇乱子伦视频| 亚洲精品色情app在线下载观看| 滋润岳的性饥渴| 欧美亚洲国产精品久久高清| 精品国产成人亚洲午夜福利| 国产对白叫床清晰在线播放| 国产免费一区二区三区在线观看| 全球欧美hd极品4k| 国产老头老太作爱视频| 和子发生了性关系的免费视频 | 又大又长粗又爽又黄少妇视频| 韩国a片巜上司与的人妻| 中国成熟妇女毛茸茸| 熟妇少妇任你躁在线无码| 成人无码精品1区2区3区免费看 | 联系附近成熟妇女| 国产伦精品一区二区三区不卡|