The ISO 18779 standard, developed by the International Standards Organization (ISO), describes the basic safety and performance characteristics and test methods of medical devices used for the protection of oxygen and oxygen mixtures. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 18779 Medical devices for the protection of oxygen and oxygen mixtures - Certain features.
Said standard specifies requirements for the safety and basic performance of portable equipment that provides the flow of oxygen or oxygen mixtures during therapy procedures such as prolonged oxygen therapy or analgesia therapy. This equipment is designed to deliver these gases intermittently depending on the patient's needs and to protect the oxygen or oxygen mixtures when used in home care applications. These devices are generally used without constant professional supervision. This equipment is also used in healthcare institutions.
The ISO 18779 standard covers two types of protection equipment: protection equipment designed for continuous use and protection equipment not designed for continuous use. This standard covers only active devices. Pneumatic or electrically controlled devices and devices such as reservoir cannulae are not covered by this standard.
This international standard also includes protection devices that are part of a system, such as pressure regulators, oxygen concentrators or liquid oxygen containers.
Several standards that are normatively referenced in the application of this standard include: EN 980, EN 1041, ISO 4135, EN 13544-2, IEC 60601-1, and IEC 60529.
Within the scope of laboratory services, our organization also provides basic safety and performance features and testing services of medical devices used for the protection of ISO 18779 oxygen and oxygen mixtures.
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