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The first CE Marking Acquired for HSN's reusable PPE Products

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작성자DYETEC 댓글댓글 0건 조회조회 1,321회 작성일 21-02-25 13:43

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The first CE Marking Acquired for HSN's reusable PPE Products

On January 21. 2021, HSN Company Ltd. announced that it has certified first CE Making (Notified Body Number: 2474 from MIRTA) for use on reusable PPE(Personal Protective Equipment) to the Regulation (EU 2016/425), Annex V.

According to European Commission, Regulation 2016/425 covers the design, manufacture and marketing of PPE. It defines legal obligations to ensure PPE on the EU internal market provides the highest level of protection against risks.

Mr. Juno Lee, CEO of HSN Company, said, “We are delighted to have obtained CE marking for our medical grade PPE suits.(Fabric, gown, mask and coverall). During the first half of 2020, our team felt the need to join the development of reusable PPE suits against COVID-19 Pandemic. The process to achieve this recognition was a remarkable accomplishment to the dedication and collaborative work of our team, HSN Company Ltd and DYETEC Institute in Korea."

With the acquisition of the certification, HSN Company intends to formally enter the European and American markets.

The Product by HSN company are the only available reusable PPE suits that successfully passed through multiple quality checks, to be accepted for use in the U.S and also EU.

Mr. Juno Lee, CEO of HSN Company, said, "To begin with, we thought it was very difficult to get certified, because there were no standards for the performance evaluation of reusable PPE suits worldwide.

Our partner, the Dyetec Institute played a critical role in acquiring accreditation. Dyetec Institute prepared a performance verification standard and supported the pre-validation of performance. Under the coronavirus pandemic, WHO and CDC in the United States are stipulating guidelines that can be reused if they are washed at 60℃~70℃ for 10 minutes and then dried at high temperatures for reusable PPE suits in hospital."

"When HSN's PPE suits goes through the process of washing, drying, and sterilization in accordance with guidelines, we have completed the verification of the maintaining performance."

At the same time as the CE acquisition, HSN signed a contract to export reusable protective clothing with a hospital group in Bavaria, Germany. In particular, Germany has requested not only the reusable verification of the maintaining performance after 'high temperature sterilization', but also the European CE performance tests like the Viral Penetration Test, Synthetic Blood penetration test and the SBPR test,

In this test, HSN's PPE suits passed the test.

Dr. Do-Hyun Lee, Vice president of Dyetec Institute, said, "Although vaccines are being administered worldwide, the demand for reusable PPE suits are still insufficient compared to the supply volume and are expected to be increase."
 
(HSN coverall HSND0022 and CE Certification)
Mr. Juno Lee, CEO of HSN Company, said additional, "During the COVID-19 pandemic, most of the world countries struggled with finance their public health, social and economic. Also, global shortages of PPEs like masks, respirators and gowns, caused by surging demand and supply chain disruptions, have led to efforts to conserve PPE through extended use and the reusable PPEs have been developed. Another advantage of reusable PPEs can be help to expand supply in virus risk area such as nursing hospitals, general clinics or hospitals.
Especially they are very attractive products for front-line health-care workers and personnel with potential exposure at the hospital's support departments."

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