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ANVISA更新INMETRO认证所要求的技术标准清单

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.

巴西医疗器械上市监管机构ANVISA已经出版了一个新的技术标准清单,一些电气医疗器械和IVD器械必须遵循这些标准以获得INMETRO证书。

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规范性指南,IN 04/2015,代替IN 11/2014,更新了IEC 60601系列标准的符合性框架。新的规范性指南包含了两个主要的更新。

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产品对INMETRO证书的要求;尤其是,IVD产品已经豁免了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 inBrazil are not yet able to test according to some 3rd editionstandards. In the meantime, manufacturers may submit test reports showingcompliance with earlier versions of the 60601 standard in order to obtain theirINMETRO certifications.

其次,新指南回调了一些巴西实验尚无能力监测的标准的符合性日期。例如,虽然IEC60601第3版系列测试对于INMETRO是强制的,巴西的实验室还不能根据这些第3版标准进行测试。同时,制造商可以提交证实已符合早期版本的60601标准以获得其INMETRO认证。

 

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