Center Certification & Testing International
Recently, with the spread of the new crown epidemic situation in many EU countries, protective masks, protective clothing, goggles and other anti-epidemic materials have become popular in the market. As the world\'s largest producer of protective equipment, Chinese companies have also ushered in a period of business outbreaks. Both traditional production enterprises and new enterprises that have switched to production hope to take this opportunity to sell their products to the EU market.
Due to the impact of the epidemic, for the EUA application of Chinese KN95 masks, FDA will quickly review the mask information in a short period of time, and publish the EUA authorized companies and product models on the official website, which is equivalent to issuing a temporary summary certificate to replace NIOSH certification.
With the rapid spread of the new coronary pneumonia epidemic, Europe has become a severely affected area. In the process of preventing and controlling the epidemic, due to the serious shortage of medical masks, protective clothing and other medical supplies, Europe has released a huge demand for protective equipment. For the EU market, CE certification is essential.
On May 7, the FDA again revised its China KN95 (FFR) mask recognition rules issued on April 3. And updated the products previously published in the white list (Appendix A), from the original 74 white list suddenly only 14 left!
Since the lithium-ion battery interview, after just four years, he has faced his first crisis: more than 1 million lithium-ion batteries in the Sony County Hill factory caught fire for unknown reasons. Subsequently, it took Sony five months to persuade the Tokyo Fire Department to avoid the \"dangerous goods\" label on lithium-ion batteries. At the same time, Sony has also conducted a lot of research on the safety performance of lithium-ion batteries, and the safety test standards for lithium-ion batteries have begun to gradually improve.
Since the lithium-ion battery interview, after just four years, he has faced his first crisis: more than 1 million lithium-ion batteries in the Sony County Hill factory caught fire for unknown reasons. Subsequently, it took Sony five months to persuade the Tokyo Fire Department to avoid the \"dangerous goods\" label on lithium-ion batteries. At the same time, Sony has also conducted a lot of research on the safety performance of lithium-ion batteries, and the safety test standards for lithium-ion batteries have begun to gradually improve.
Recently, since the three ministries have clearly required that all exported medical supplies must have a medical device product registration certificate approved by the drug regulatory authority in order to be released, many manufacturers who initially wished to obtain CE certification for medical masks through self-declaration began to export to Europe.
In the changing era of digital technology, the safety standards for audio-visual products (AV) and information technology equipment (ITE) products have gradually changed from passive safety regulations (IEC/EN 60065 & IEC/EN 60950-1) in the past to actively preventing potential Dangerous safety standard IEC/EN 62368-1:2014 (Second Edition).
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