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)。

清纯校花被c得欲仙欲死| 日日噜噜噜夜夜爽爽狠狠| 欲妇荡岳丰满少妇a片24小时| 久久精品国产亚洲av高清色欲| 人人妻人人澡人人爽欧美一区| xx性欧美肥妇精品久久久久久| 小SAO货水好多真紧H无码视频| 国产精品久久久久9999赢消 | 无码人妻精品一区二区三区9厂| 亚洲熟女综合色一区二区三区| 肉大捧一进一出免费视频| 特黄a级毛片| 亚洲暴爽av天天爽日日碰| 纯肉高h啪动漫| 激情五月综合色婷婷一区二区| 亚洲午夜无码av毛片久久| 精品无码一区二区三区爱欲| 无遮挡边吃摸边吃奶边做| 天码av无码一区二区三区四区| 好爽又高潮了毛片免费下载| 国产人妻久久精品二区三区特黄 | 最近韩国日本免费高清观看 | 性无码专区无码| 疯狂做爰18分钟视频| 精品一品国产午夜福利视频| 无码AⅤ精品一区二区三区浪潮| 国产乡下妇女做爰| 少妇被躁爽到高潮无码人狍大战| 日韩av无码免费播放| 亚洲av之男人的天堂| 欧美熟妇另类久久久久久不卡 | 日本天狼无码久久久久影院| 老师的粉嫩小又紧水又多a片视频 久久久久精品国产三级美国美女 极品白嫩的小少妇 | 欧美精品一区二区少妇免费a片| 国产小受呻吟av视频在线观看| 一受多攻同做h嗯啊巨肉| 欧美一区二区三区| 日本人妻伦在线中文字幕| 老赵揉着粉嫩的双乳| 特黄三级又爽又粗又大| 肉乳乱无码a片观看免费|