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Normas DIN – AENOR
DIN EN ISO 8359/A1:2012-10

DIN EN ISO 8359/A1:2012-10

Oxygen concentrators for medical use - Safety requirements - Amendment 1 (ISO 8359:1996/Amd 1:2012); German version EN ISO 8359:2009/A1:2012 / Note: A transition period, as set out in DIN EN ISO 80601-2-69 (2014-12), exists until 2017-07-31.

Concentrateurs d'oxygène à usage médical - Prescriptions de sécurité - Amendment 1 (ISO 8359:1996/Amd 1:2012); Version allemande EN ISO 8359:2009/A1:2012 / Attention: Il existe un délai de transition comme fixé en DIN EN ISO 80601-2-69 (2014-12) jusqu'à 2017-07-31.

Sauerstoff-Konzentratoren für medizinische Zwecke - Sicherheitsanforderungen - Änderung 1 (ISO 8359:1996/Amd 1:2012); Deutsche Fassung EN ISO 8359:2009/A1:2012 / Achtung: Übergangsfrist, festgelegt durch DIN EN ISO 80601-2-69 (2014-12), bis 2017-07-31 beachten.

Fecha Anulación:
2014-12 /Withdrawn
Equivalencias internacionales:

EN ISO 8359/A1 (2012-07)

ISO 8359 AMD 1 (2012-07)

Relación con otras normas DIN:
Resumen:
The document specifies safety requirements for continous-flow oxygen concentrators. It does not apply to oxygen concentrators intended to supply gas to several patients via a piped medical gas installation or to those intended for use in the presence of flammable anaesthetic and/or cleaning agents.This amendment covers additional requirements to address fire protection during use of oxygen concentrators in the home healthcare environment. These include applicable requirements on information to be provided by the manufacturer, additional requirements for the equipment and accessories as well as related test methods.
Das Dokument legt Sicherheitsanforderungen für Sauerstoff-Konzentratoren mit kontinuierlichem Durchfluss fest. Es gilt nicht für Sauerstoff-Konzentratoren, die für die Versorgung mehrerer Patienten über einer Zentralversorgungsanlage für medizinische Gase vorgesehen sind oder zum Einsatz mit entflammbaren Narkose- und/oder Reinigungsmitteln. Mit der Änderung 1 wird die Norm um Anforderungen ergänzt, die auf den Brandschutz bei Einsatz von Sauerstoff-Konzentratoren in der häuslichen Umgebung abzielen. Diese beinhalten relevante Herstellerinformationen, zusätzliche Anforderungen an das Gerät und das Zubehör sowie zugehörige Prüfverfahren.
Keywords:
Accident prevention, Alpha radiation, Assembling, Beta radiation, Biocompatibility, Bodies, Breathing apparatus, Breathing equipment, CE marking, Chargings, Clamps, Classification, Cleaning, Colour codes, Components, Concentrators, Connections, Continuous current, Corners, Covers, Defects, Dielectric strength, Disinfection, Earth conductors, Earthing conductor terminations, Edge, Electric power systems, Electric shock, Electrical hazards, Electrical safety, Electromagnetic compatibility, Electrostatics, EMC, Enclosures, Energy, Environmental conditions, Environmental testing, Equipment safety, Explosion hazard, Explosion protection, Failure, Fire prevention, Fire protection, Fire risks, Fire safety, Gamma-radiation, Gases, Grids, Heat protection, Human errors, Hydraulics, Indications, Infrared radiation, Inner atmosphere, Input current, Inscription, Inspection, Instructions for use, Instruments, Interruptions, Laser beams, Layout, Liquids, Luminous radiation, Marking, Mass, Mechanical hazards, Mechanical safety, Medical breathing apparatus, Medical devices, Medical equipment, Medical gases, Medical sciences, Medical technology, Medicinal plants, Microwave radiation, Moisture, Noise, Occupational safety, Operational instructions, Outlets, Overflows, Oxygen, Oxygen breathing apparatus, Oxygen concentration, Paper, Patient auxiliary current, Pneumatics, Potential equalization, Power consumption, Precision, Pressure, Pressure vessels, Protection, Protection against danger, Protection coverings, Protective devices, Radiation protection, Safety, Safety engineering, Safety of products, Safety requirements, Separation, Sound, Sound energy, Specification, Specification (approval), Specifications, Stability, Sterilization (hygiene), Strength of materials, Stress, Supply, Surfaces, System earthing, Technical data sheets, Temperature, Test set-ups, Testing, Thermal hazards, Thermal protection, Ultrasonics, Ultraviolet radiation, Use, Vibrations, Voltage, Working data
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