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As panic over the COVID-19 pandemic spreads, shelves around the world are being emptied of protective gear.  In early March, the World Health Organization (WHO) called on industry and governments to increase manufacturing by 40%.  Since then, China has been producing 200 million face masks a day.  But that's still not nearly enough to meet local demands as well as global orders.  Since most factories are running out of their capacity, local manufacturers have joined in to ease the pressure.

Surgical masks sold in the EU require a CE mark as they are a class-one medical device and must prove features such as breathability, splash resistance and efficiency in filtering bacteria. A similar test is performed in the US by the Food and Drug Administration (FDA).

SGS Hong Kong has vamped up its arsenal of testing equipment to accommodate the increased demand for testing, especially for local manufacturers, in order to reduce the time required for comply with various mandatory international standards, such as ASTM 2100 (US), EN 14683 (EU), YY 0496 and YY/T 0969 (China) & AS 4381 (AUS).  Our one-stop solution includes:

Market Test Standard Test Items
EU EN 14683: 2019 + AC: 2019 Barrier Levels

Barrier Testing: BFE%, PFE% & Synthetic Blood

Physical Testing: Differential Pressure

Safety Testing: Flammability, Microbial Cleanliness & Biocompatibility*

US ASTM F2100-19

Bringing Clarity to the Marketplace

Consumers want to know that the products they buy are safe, but with a mass of approval, safety and quality marks available, the modern marketplace can be a confusing environment for consumers.

SGS’s QR Code allows users direct access to the online database for that specific product.  An important aspect of this program is greater transparency and increased understanding of a product and will help to simplify the often-confusing world of product marks.  QR Code
   

 

SGS’s medical device testing, certification, audit and training services can help you navigate the complexities of international medical device regulations to bring your products to market while ensuring compliance with the required regulations and standards and providing a high level of safety to patients and healthcare professionals. 

For Mask Total Quality Solution, Please contact us
For Melt blown Examination, please contact us

 


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