Norm

NEN-EN-ISO 18779:2005 en

Hulpmiddelen voor het bewaren van zuurstof en zuurstofmengsels - Speciale eisen

98,05

Over deze norm

Status Definitief
Aantal pagina's 25
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 01-06-2005
Taal Engels
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.

Details

ICS-code 11.040.10
Nederlandse titel Hulpmiddelen voor het bewaren van zuurstof en zuurstofmengsels - Speciale eisen
Engelse titel Medical devices for conserving oxygen and oxygen mixtures - Particular requirements
Vervangt
Wordt vervangen door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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