Sources

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Mask List

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• NIH 3D Print Exchange: COVID-19 Response – NIH, FDA, VA, America Makes (4/06)
  • NIH Approved mask – Stopgap Surgical Face Mask (SFM)
    • Test Report
• Montana Mask

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Regulation 

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ASTM (Covers NIH, VHA, FDA)

• VHA Innovation Ecosystem (USA) – (4/6)
  • Memorandum of Understanding: NIH, FDA, VA (3/26)
• ASTM International Standards, Testing & COVID-19 – ASTM (3/30)
  • ASTM International is providing no-cost public access to important ASTM standards used in the production and testing of personal protective equipment.

FDA

• FDA 510(k) Submission Process – FDA
• Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) – FDA (4/1)
• FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic – FDA (3/26)
• Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) – FDA (3/25)
• Non-NIOSH-approved disposable filtering facepiece respirators within the context of the posted EUA permitted for use – FDA (3/28)

Sanitization

• Infection Prevention and Control in Healthcare Settings (CDC)
  • Using Personal Protective Equipment (PPE) (CDC)
• Decontamination and Reuse of Filtering Facepiece Respirators (CDC)
• Advice on the use of masks in the context of COVID-19 – WHO
• Cleaning and Disinfection of Respiratory Equipment (WHO)
• Face Shield Disinfection (Prusa)
• Plastics Sterilization Compatibility (Industrial Spec)

Research

• “Worst case” aerosol testing parameters – PubMed (1989)
  • Sodium chloride filter efficiency testing by particle size and flow rate