Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)
IEC 60601-1:1988, Clause 1, applies except as follows:
Amendment (add at end of 1.1):
This International Standard 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 devices1) 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.
This International Standard covers two types of conserving devices (see 3.5 and 3.6): conserving devices intended for continuous use and those not intended for continuous use.
This International Standard 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.
The requirements of this International Standard which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.
NOTE Planning and design of products complying with this International Standard can have environmental impact during the product life cycle. Environmental aspects are addressed in Annex BB. Additional aspects of environmental impact are addressed in ISO 14971.