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Face Mask Regulations and Standards in the US: An Overview

The ASTM F2299 provides the standard test method for measuring the PFE of the surgical mask. Similar to the BFE, ASTM has also categorized the masks with different PFE into 3 levels: ASTM Level 1 Surgical masks – PFE ≥ 95%@0.1 micron, Fluid resistance 80 mmHg; ASTM Level 2 Surgical masks – PFE ≥ 98%@0.1 micron, Fluid resistance 120 mmHg

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Face Mask Regulations and Standards in the EU: An Overview

There are several accredited testing companies that provide MDD testing services for face mask products, which include Bureau Veritas, SGS, Intertek, and TUV. Quality Management System (ISO 13485) If your surgical masks are classified as sterile, then the MDD requires that the manufacturer has a quality management system (QMS) in place.

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SGS is the world's leading inspection, verification, testing and certification company. We are recognized as the global benchmark for quality and integrity.

Medical Devices | Life Sciences | SGS

No matter the size of your organization, 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.

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Xianning ECO Medical Articles Co., Ltd was founded in 2009. We are the most professional manufacturer for disposable medical health materials, surgical protective articles, home health care items and industrial protective products.

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Our Eurofins Medical Device Testing’s Certification Services help manufacturers gain access to global markets in a cost and time efficient manner. Services include Global Market Access, NRTL, SCC, Health Canada, FDA reports, Notified Bodies, CB Scheme, ISO 13485 audits & MDSAP.

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