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All Quality Standards in Place

AirSep Corporation is the ONLY PSA oxygen manufacturer that meets the following standards of construction

  • CE as per Medical Devices Directive 93/42/EC & Latest amendment 2007/47/EC.
  • NEMA ( National Electrical Manufacturers Association)
  • EN-ISO 13485 (2012)
  • CSA/CRN ( Canadian Standards Association/Canadian Registration Number)
  • NYFD (New York Fire Department)
  • NRTL-UL 3101.1 ( Nationally Recognized Testing Laboratory/Underwriters Lab)
  • Indian FDA.

The system oxygen complies with

  • USP93XXII (United States Pharmacopoeia)
  • EUROPIAN Pharmacopoeia
  • Indian Pharmacopoeia
  • HTM 2022
  • We use ISO 8573-1 Class-A Compliant clean & dry compressed feed air package which includes

CSA International (Canadian Standards Association), a member of the CSA Group, is a provider of product testing and certification services for electrical, mechanical, plumbing, gas and a variety of other products. Recognized in the U.S., Canada and around the world, CSA’s marks appear on billions of products worldwide.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a directorate of the Council of Europe that traces its origins and statutes to an international treaty enabling an international cooperation for the elaboration of a common pharmacopoeia in Europe (Convention on the Elaboration of a European Pharmacopoeia, CETS 50, Council of Europe in 1964.

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed[5] and veterinary products.

The International Organization for Standardization (ISO) is an international standard-setting body composed of representatives from various national standards organizations. Founded on 23 February 1947, the organization promotes worldwide proprietary, industrial and commercial standards. It is headquartered in Geneva, Switzerland,[4] and as of 2013 works in 164 countries.

The Laboratoire national de métrologie et d'essais (National Laboratory of Metrology and Testing) is a French reference laboratory responsible for carrying out measurement and testing products of all kinds for their certification for placing them on the market. It also coordinates metrology activities in France. It was previously known as the Laboratoire national d'essais (LNE), and still uses those initials.