ISO9001, ISO13485 and ANNEX II
ISO (International Standards Organization) has set quality standards to help guide manufacturing of products to maintain consistency. They provide a standard which is understood and recognized world wide.  ISO is a network of the national standards institutes of some 130 countries, with a central office in Geneva, Switzerland, that coordinates the system and publishes the finished standards.

When the large majority of products or services in a particular business or industry sector conform to international standards, a state of industry-wide standardization can be said to exist. This is achieved through consensus agreements between national delegations representing all the economic stakeholders concerned: suppliers, users, and, often, governments. They agree on quality standards and required documentation to verify the standards are met. In this way, international standards provide a reference framework, or a common technological language, between suppliers and their customers that facilitates trade and the transfer of technology. The year 2000 and 2003 has set new revised standards for ISO with a three year transition period. Sea-Long Medical Systems is currently certified at ISO9001 and ISO13485.

CE Marking
The European commission refers to the CE marking of products as a "passport" which can allow a manufacturer to freely circulate their products within the European marketplace. The marking applies only to products regulated by European health, safety, and environmental protection legislation (product directives), but this is estimated to include more than 50% of the goods currently exported from the U.S. to Europe.

The actual CE marking is the letters "CE," which a manufacturer affixes to certain products for access to the European market (consisting of 18 countries and also referred to as the European Economic Area, or EEA). The letters "CE" are an abbreviation of the French phrase "conformite Europeene." The marking indicates that the manufacturer has conformed with all the obligations required by the legislation. Initially, the phrase was "CE Mark," but "CE Marking" was legislated as its replacement in 1993.

All medical devices are required to have the CE mark when selling to countries in both the European Union and the European Free Trade Association.

FDA
The U.S. Food and Drug Administration regulates the manufacture and marketing of medical devices in the United States. In 1976,  Congress passed legislation giving the FDA broad authority over medical devices. The new law also required that, in most cases, marketing of a device could not legally begin until the FDA finds that the device is safe and effective. The law was amended in 1990 and again in 1992 to further expand the FDA's authority, increase its enforcement powers, and require device manufacturers and others to report adverse device experiences to the FDA.

Class II devices are subject to the same general controls as Class I devices, and in addition must meet "performance standards" if adopted by the FDA. Devices which meet such performance standards may arguably be exempt from state product liability actions, based on federal preemption. The Sea-Long oxygen hood is a Class II device.