SRPS EN ISO 18779:2011

Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)

Scope

ISO 18779:2005 specifies requirements for the safety and essential performance of portable devices that supply the flow of oxygen or oxygen mixtures during therapy (e.g. long term oxygen therapy, analgesia).
These devices are intended to conserve oxygen or oxygen mixtures by delivering these gases intermittently on the patient's demand when used in home care applications. These devices are generally used without continual professional supervision. These devices are also used in health care facilities/institutions.
ISO 18779:2005 covers two types of conserving devices: conserving devices intended for continuous use and those not intended for continuous use. It covers active devices only, e.g. pneumatically or electrically controlled devices and does not cover devices such as reservoir cannulas.
This International Standard also includes conserving devices which are part of a system e.g. pressure regulators, oxygen concentrators or liquid oxygen vessels.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.