ASTM International is committed to helping address the challenges that medical providers, patients, and manufacturers are facing during the COVID-19 pandemic. ASTM committees, Centers of Excellence, and partner organizations are providing our resources and expertise to address supply chain shortages.
ASTM Response to COVID-19
ASTM International Additive Manufacturing Center of Excellence (AM CoE) is working to increase the quality of designs submitted to America Makes portal and shorten the design, review, and selection process. To do so, the AM CoE has put together a COVID-19 Response Guide. These documents will provide guidance to designers responding to the needs of healthcare workers and patients during COVID-19. The guides are available for download below.
ASTM International is providing no-cost public access to important ASTM standards used in the production and testing of personal protective equipment – including face masks, medical gowns, gloves, and hand sanitizers – to support manufacturers, test labs, health care professionals, and the general public as they respond to the global COVID-19 public health emergency. The full list of available standards is available on our website. You may view the 20+ standards by clicking here.
Design for Additive Manufacturing
In response to the COVID-19 emergency, many individuals/organizations are willing to help by sharing medical part designs.
Designers working on products to be fabricated with Additive Manufacturing (AM) should be aware of the unique capabilities and limitations of these processes. This brief guide draws from AM standards to provide guidance for designers responding to the needs of healthcare workers and patients during COVID-19.
Resolving Supply and Demand Disruptions with Additive Manufacturing
In response to COVID-19, many companies are working to create the equipment needed to treat patients and protect healthcare workers. Medical device companies are quickly scaling manufacturing operations while other manufacturing companies are adapting their operations to assist. Some companies are experiencing difficulty in getting parts and tooling necessary for their operations, as suppliers and transportation networks adapt to containment measures for COVID-19.
Introducing additive manufacturing into the supply chain will help organizations overcome some of these challenges.
Flexibility to increase short term production capacity with shorter changeover and no additional capital expenses
Shorten production ramp for conventional manufacturing with AM tool
Manufacture parts closer to point of use, reducing impact of disruptions to transportation
Additive Manufacturing capacity can be added without new capital expenses by identifying conventional suppliers with AM capabilities or adding AM-exclusive service bureaus to your supply chain
Enable supply chain disintermediation by reducing components when you follow Design for Additive Manufacturing (DfAM) guidelines to take advantage of unique AM features.
Personal Protective Equipment (PPE)
- Face Shield
- Face Mask
- Air exchanger
- Filter adapter
- In-line filter housing
- Ventilator splitter
- Flow restriction device
- Shorten production ramp for conventional manufacturing
Additive Manufacturing Community Response
As a result of COVID-19 pandemic, some companies are experiencing difficulty in getting parts and tooling necessary for their operations as suppliers and transportation networks adapt to containment measures for COVID-19. Introducing additive manufacturing (AM) into the supply chain will help organizations overcome some of these challenges.
America Makes is partnering with the Food and Drug Administration (FDA) to help ensure the AM industry can effectively and safely meet the needs of America’s health care workers on the front lines of the Coronavirus crisis. To do so, they are maintaining a portal where organizations can submit their AM capabilities, designs, or health care PPE needs, to help match manufacturing capabilities with needs. The site will record necessary information from both the AM industry and health care providers and eventually include a pathway for designs to be uploaded for review to ensure they meet medical standards and regulatory acceptance.
ASEAN Additive Manufacturing Standards Strategic Guidance Document
As one of the world’s fastest growing regions, Southeast Asia is primed to take advantage of new technologies to continue its economic and human development. As new manufacturing techniques like AM continue to rapidly evolve, the potential benefits for the countries of Southeast Asia, from higher tech jobs and more resilient supply chains to improved health and cheaper, safer manufacturing, could be immeasurable. To facilitate the adoption of AM technologies in the region, this report, produced by ASTM International – a leading developer of AM technical standards – with support from the U.S. Department of Commerce’s International Trade Administration, provides key strategic and technical guidance for the adoption of AM standards for ASEAN member states.The findings and recommendations contained in this report draw from interviews with AM standards experts and thought leaders in the AM industry from countries such as U.S., Singapore, Australia, Japan, UK, Norway, and Sweden, and include a comprehensive review of current and pending standards specific and related to AM technologies.
ASTM Standards & COVID-19
ASTM F3502−21 Standard Specification for Barrier Face Coverings.
ASTM F2299/F2299M-03(2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
ASTM F2100-19E01 Spécification normalisée pour la performance des matériaux utilisés dans les masques médicaux
ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
ASTM F1494-14 Standard Terminology Relating to Protective Clothing
ASTM F3407-20 Standard Test Method for Respirator Fit Capability for Negative-Pressure Half-Facepiece Particulate Respirators
ASTM F2407 – 06(2013)e1 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
ASTM F1671 / F1671M – 13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
ASTM F1868 – 17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
ASTM D751 – 19 Standard Test Methods for Coated Fabrics
ASTM D1683/D1683M-17(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics
ASTM D1776/D1776M-20 Standard Practice for Conditioning and Testing Textiles
ASTM D5034-09(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
ASTM D5587-15(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
ASTM D5733 – 99 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure (Withdrawn 2008)
ASTM D6701-16 Standard Test Method for Determining Water Vapor Transmission Rates Through Nonwoven and Plastic Barriers
ASTM F1494-14 Standard Terminology Relating to Protective Clothing
ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D3578-19 Standard Specification for Rubber Examination Gloves
ASTM D5250-19 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
ASTM D6977-19 Standard Specification for Polychloroprene Examination Gloves for Medical Application
ASTM E2755-15 Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Healthcare Personnel Hand Rub Formulations Using Hands of Adults
ASTM E1174-13 Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations
ASTM E3058-16 Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations
ASTM E1838-17 Standard Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
ASTM E2613-14 Standard Test Method for Determining Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using Fingerpads of Adults
ASTM E2870-19 Standard Practice for Evaluating Relative Effectiveness of Antimicrobial Handwashing Formulations using the Palmar Surface and Mechanical Hand Sampling
ASTM E2011-13 Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire Hand
ASTM F3387-19 Standard Practice for Respiratory Protection
ASTM E1104-98 Standard Specification for Clinical Thermometer Probe Covers and Sheaths