Labeling of secondary (rechargeable) batteries for medical devices

Labeling of accumulators as a part of medical devices is required – full information in our new technical regulation issue.
Read moreLabeling of accumulators as a part of medical devices is required – full information in our new technical regulation issue.
Read moreIn one of the previous articles we discussed necessary symbols, that must contain label of medical devices for state registration in Russia. Today we present symbols, that must contain label of active medical devices. They are presented in the Table 1. Table 1 – Necessary symbols Power source parameters 1. Power (I or P) Consuming current or power GOST R
Read moreToday we speak about some easy but necessary rules in Russia – labeling, marking of medical devices must comply with in order to medical device could be registered in Russian Federation. Should be noticed, that all the labeling rules (except the electrotechnical symbols) are regulated by 3 standards: GOST R 50444, GOST R ISO 15223 and GOST 14192. The last
Read moreIn one of previous articles we discuss quantity of medical device samples for toxicological testing (biocompatibility trials). Current article is about necessary number of stomatology (dental) material samples for toxicological testing. The standard regulated this quantity in Russia is GOST 31576. And its actual version is GOST 31576-2012. The 3rd section of these standards contain the table, regulating the necessary number
Read moreTechnical regulation – 2018. Part 3.
Read moreNecessary number of medical device samples for toxicological testing.
Read moreDear colleagues, we will start our journey into the secrets of Russian standards, concerned with medical devices with a short review of the technical regulation in Russia and the exploration of certification systems GOST, GOST R, GOST R IEC and GOST R ISO. The certification system GOST R – is the biggest certification system in Russia. Moreover, this is the
Read moreThe transfer of Russian economics to Eurasian Economic Union leads on the changes in the routines of State registration for medical devices. One of the recommendation of Federal Service for Surveillance in Healthcare, concerned with the Russian transfer to Eurasian Economic Union is (Recommendation No. 17). It contains the list of standards, the application of which, on a voluntary basis,
Read moreВсе медицинские изделия, находящиеся в обращении на территории Российской Федерации, подлежат мониторингу безопасности. Одним из частых нарушений, обнаруживаемых в ходе таких мониторинговых мероприятий, является невозможность идентификации рассматриваемого устройства. Каждое медицинское изделие должно быть четко идентифицировано; все продажи должны осуществляться только под торговым наименованием, указанным в регистрационном удостоверении, и в соответствии с информацией, представленной в мастер-файле (заявочном досье). Маркировка является основной
Read moreA list of standards which, on a voluntary basis, fully or partially ensure compliance of medical devices with the General requirements of safety and efficacy of medical devices, the requirements for their labeling and maintenance documents approved by the recommendation of the Eurasian Economic Commission panel. You could find recommendation #17 by link (in English) – EAC #17 (standards) ; (in Russian)
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