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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。

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