Norm

ISO/DIS 18562-3:2015 en

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs)

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Over deze norm

Status Ontwerp
Aantal pagina's 21
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 12-11-2015
Taal Engels
This part of ISO 18562 specifies tests for the emissions of VOLATILE ORGANIC COMPOUNDS (VOCs) from theĀ - GAS PATHWAYS of a MEDICAL DEVICE, its parts or ACCESSORIES, which are intended to provide respiratory - care to a PATIENT in all environments. The tests of this International Standard are intended to quantify - emissions of VOCs that are added to the respirable gas stream by the materials of the GAS PATHWAY. ThisĀ - International Standard establishes acceptance criteria for these tests. - This International Standard addresses potential contamination of the gas stream arising from the GAS - PATHWAYS, which is then conducted to the PATIENT. - This Standard applies over the EXPECTED SERVICE LIFE of the MEDICAL DEVICE in NORMAL USE, and should - take into account the effects of any intended processing or reprocessing. - This International Standard does not address biological evaluation of the surfaces of GAS PATHWAYS that - are in direct contact with the PATIENT. The requirements for direct contact surfaces are found in the - ISO 10993 (series). - MEDICAL DEVICES, parts or ACCESSORIES containing breathing GAS PATHWAYS that are addressed by this - standard include, but are not limited to ventilators, anaesthesia workstations (including gas mixers), - breathing systems, oxygen conserving devices, oxygen concentrators, nebulisers, low pressure hoses, - humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, - mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces, and any breathing - ACCESSORIES intended to be used with such devices. The enclosed chamber of an incubator, including the - mattress, and the inner surface of an oxygen hood are considered to be GAS PATHWAYS and are also - addressed by this standard. -This standard does not address contamination already present in the gas supplied from the gas sources - while MEDICAL DEVICES are in NORMAL USE.

Details

ICS-code 11.040.10
Nederlandse titel Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs)
Engelse titel Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs)

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