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Face Mask Regulations and Standards in the EU: An Overview

Tobi Doeringer May 13, 2020 at 12:17 am . Do Type IIR masks need a CE mark assuming they have passed all tests? EN says the requirements on the packaging are ‚only‘: Both the Medical Device Directive (93/42 / EEC) and the Medical Device Regulation (EU) 2017/745 specify the information that should appear on the packaging in which the medical face mask is supplied.

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The US FDA has issued “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)” May 2020. This revision includes updates regarding alternatives when FDA-cleared or NIOSH-approved N95 respirators are not available.

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CDC - NIOSH - NPPTL - Respirator Testing

Title 42 Code of Federal Regulations, Part 84 requires that respirators submitted for evaluation against the terms of the Standard must be accompanied by data that demonstrate the respirator under evaluation meets or exceeds the performance requirements set forth therein.

Respirator Certification Fees Final Rule | NPPTL | NIOSH | CDC

Jan 29, 2018 · A final rule establishing a new fee schedule for the certification and approval of respiratory protective devices was published in the Federal Register on January 26, 2015. The final rule amends 42 CFR Part 84, Approval of Respiratory Protective Devices and creates two new fee schedules: one that specifies annual or fixed fees, and the other ...

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To comply with Medical Devices and In Vitro Diagnostic European Regulations (EU) 2017/745 and (EU) 2017/746, the management team of SGS Notified Body have signed Declaration of Interests. We have also outlined our commitments in our Global Declaration of Integrity .

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The most pressing need in the times of COVID-19 is making the Personal Protective Equipment (PPE) like N95 respirator available for healthcare workers. But, as you may know, the rapid spread of the pandemic in the U.S., and the shortage of such equipment has triggered more challenging scenarios. Addressing to the demanding times, one of our clients – manufacturer of novel

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Products | Essential Services Company

SGS (formerly Société Générale de Surveillance (French for General Society of Surveillance)) is a multinational company headquartered in Geneva, Switzerland which provides inspection, verification, testing and certification services. It has more than 94,000 employees and operates over 2,600 offices and laboratories worldwide. It ranked on Forbes Global 2000 in 2015, 2016 and 2017.

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