Release time:
2018
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02
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06
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MDD application process The European Union divides medical machinery products into four categories, namely Class I, Class IIa, Class IIb, and Class III. Class I products need to be labeled with the CE mark and can be self declared. That is, the manufacturer prepares technical documentation files for the product, and at the same time tests the product according to relevant EN standards or entrusts a capable laboratory to test and pass the test. If Class IIa, IIb, and III products need to be labeled with the CE mark, they must be verified by a verification agency designated by the Eu...
Release time:
2018
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02
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05
Source:
To successfully pass CE certification for medical device products, three aspects of work need to be done well.Firstly, collect EU technical regulations and EU (EN) standards related to certified products, and digest, absorb, and incorporate them into enterprise product standards.Secondly, the enterprise strictly organizes production in accordance with the above product standards, which means implementing the requirements of the technical regulations and EN standards into the entire process of product design, development, and production manufacturing.Thirdly, enterprises must establish and main...
Release time:
2018
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02
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02
Source:
What does RoHS mean On February 13, 2003, the European Parliament and the European Commission issued the 'Waste Electronic and Electrical Equipment Directive' (referred to as the 'WEEE Directive') and the 'Restriction of the Use of Certain Hazardous Substances in Electronic and Electrical Equipment Directive' (referred to as the 'RoHS Directive') in their official gazettes. 《RoHS Directive》gentle《weee directive》There are 102 types of products in ten major categories that are regulated to be included in the management of hazardous...
Release time:
2018
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01
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26
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一、Fill out the Bede REACH application form1. The handwriting should be clear, such as the number 0 and the English letter O, the number 5 and the English letter S, the number 1 and the English letter I, the number 9 and the English letter P, and the number 2 and the English letter Z should be clearly marked.2. Clearly fill in the testing requirements and indicate the standards or testing methods used as much as possible3. Clear selection of service nature; Working days are the time for verbal notification of results, excluding holidays, sample delivery, receipt, report printing, and mailing.4....
Release time:
2018
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01
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25
Source:
FCC is an abbreviation for the Federal Communications Commission, an independent agency of the US government directly responsible to Congress. The FCC coordinates domestic and international communication by controlling radio broadcasting, television, telecommunications, satellites, and cables.FCC certification is a mandatory certification in the United States, which stipulates that electronic and electrical products with operating frequencies above 9KHZ must undergo FCC certification (electromagnetic compatibility certification). There are three common authentication methods: Certification, Do...
Release time:
2018
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01
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16
Source:
On March 9, 2017, the European Chemicals Administration (ECHA) conducted a public review on the inclusion of two potential substances of high concern (SVHCs) in the seventeenth batch of SVHC candidate substances, with a 45 day public consultation period ending on April 24, 2017.On June 16, 2017, the European Chemical Administration (ECHA) announced that bisphenol A and perfluorohexanesulfonic acid and their salts would be added to the SVHC list by the end of June 2017, becoming the 17th batch of SVHC candidate substances.Latest added substance information:Bisphenol A was previously added to th...
Release time:
2018
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01
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10
Source:
September 10, 2015，US FDARelease the news and confirm that the first two of the seven important rules under the framework of the Food Safety Modernization Act have been completed. These two rules focus on prioritizing the prevention of foodborne diseases, aligning imported food with domestically produced food standards, and collaborating with state and local governments to create a comprehensive national food safety system.According to recent data from the Centers for Disease Control and Prevention in the United States, it is estimated that approximately 48 million people (or 1 in 6 Americans)...
Release time:
2017
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07
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06
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Release time:
2017
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06
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25
Source:
China is the world's largest toy production and export country, accounting for more than 70% of the international toy market. There are approximately 9000 export enterprises, and our products are distributed in more than 100 countries and regions around the world. Behind the seven consecutive 'boom' in toy exports, there are many difficulties that need to be actively addressed, such as stricter foreign technical trade protection, constantly raising export barriers, intensifying risks, and increasing costs.New Changes in Technical Standards and Regulations for Toys AbroadOn the EU s...
Release time:
2017
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06
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25
Source:
The new EU standard EN 55035 will replace the previously applicable EN 55020 and EN 55024 for multimedia devices, as well as their amendments.EN 55035 Applicable product range:The multimedia standard includes previous EN 55020 (AV) and EN 55024 (ITE) products, as well as multimedia products for professional purposes.Detailed testing requirements for EN 55035:The testing requirements of EN 55035 are not a simple superposition of the testing requirements of EN 55020 and EN 55024. Here, we compare the requirements of key testing items to gain a clear understanding of EN 55035.1、 Test items with t...