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ANSI Expands COVID-19 Resource Portal with ISO Respiratory Equipment Standard

12/06/2021

ANSI and Standardization Community Support Recovery with Timely Pandemic Response Efforts

As part of its long-term dedication to help speed global COVID-19 efforts, and in response to requests from the standardization community to support recovery, the American National Standards Institute (ANSI) has expanded its COVID-19 resource portal to include ISO 80601-2-90:2021. The International Organization for Standardization (ISO) standard covers the basic safety and essential performance of respiratory high-flow therapy equipment.

The ANSI portal, Freely Available ISO and IEC Standards to Help Address COVID-19 Crisis, now includes access to 39 international standards—available at no costcovering medical equipment and devices - including ventilators and respiratory equipment; protective clothing used in health care settings; and business continuity management, security, and resilience. ANSI is the coordinator of the U.S. voluntary consensus standardization system. It is the U.S. member body to ISO, and via the U.S. National Committee, the International Electrotechnical Commission (IEC).

“We are pleased to announce the expansion of ANSI’s portal to include this critical standard amid the continuing COVID crisis,” said ANSI president and CEO Joe Bhatia. “ANSI appreciates ISO’s partnership in responding so quickly to the urgent request.”

The ISO and IEC standards in the ANSI portal are accessible in read-only format during the COVID-19 crisis and recovery period; additional standards may be added in the future. To access the portal, users must accept the license agreement and register. Once registered, users can return to the portal via https://asc.ansi.org.

About ISO 80601-2-90:2021

The newest addition, ISO 80601-2-90:2021, Medical electrical equipmentPart 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment, is also referred to as “ME equipment” or “ME system,” in combination with its accessories, and is:

  • intended for use with patients who can breathe spontaneously; and
  • intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed.

The standard was developed by ISO Technical Committee 121, Anaesthetic and respiratory equipment, Subcommittee 3, Respiratory devices and related equipment used for patient care, for which ANSI serves as the Secretariat.

Additional COVID-19 Resources and Updates

In addition to its portal, ANSI continues to add content to its COVID-19 Resource Webpage highlighting activities of the U.S. standardization community in the fight against the pandemic. Available at ansi.org/COVID-19, the resource page spotlights ANSI members' activities supporting public health, safety, and infrastructure, and includes important ANSI announcements, distance learning opportunities, and other resources.

About ANSI

The American National Standards Institute (ANSI) is a private non-profit organization whose mission is to enhance both the global competitiveness of U.S. business and the U.S. quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems, and safeguarding their integrity. Its membership is comprised of businesses, professional societies and trade associations, standards developers, government agencies, and consumer and labor organizations.

The Institute represents and serves the diverse interests of more than 270,000 companies and organizations and 30 million professionals worldwide. ANSI is the official U.S. representative to the International Organization for Standardization (ISO) and, via the U.S. National Committee, the International Electrotechnical Commission (IEC). For more information, visit www.ansi.org.

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