Norm

ISO/DIS 18562-4:2015 en

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate

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Over deze norm

Status Ontwerp
Aantal pagina's 14
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 12-11-2015
Taal Engels
This part of ISO 18562 is intended to protect PATIENTS connected to MEDICAL DEVICES from excessive 95 amounts of harmful substances that might be contained in water that has condensed in the GAS 96 PATHWAYS of those MEDICAL DEVICES. This standard represents the application of the best-known science 97 by addressing the RISKS from potentially hazardous substances in the condensate being conveyed to the 98 PATIENT by the gas pathway. The condensate itself will be distilled water, having condensed from the 99 vapour phase, but liquid water present in the breathing system might be able to leach or absorb other 100 substances from within the MEDICAL DEVICE. This contamination might be from the original - manufacturing PROCESS, or be generated by the MEDICAL DEVICE itself during use. - This standard is intended to cover the biological evaluation of respiratory GAS PATHWAYS of MEDICAL - DEVICES within a RISK MANAGEMENT PROCESS, as part of the overall MEDICAL DEVICE evaluation and - development. This approach combines the review and evaluation of existing data from all sources with, - where necessary, the selection and application of additional tests. - In general, ISO 10993 is intended to cover the biological evaluation of MEDICAL DEVICES. However, the - ISO 10993 series does not appropriately address the biological evaluation of the respiratory GAS - PATHWAYS of MEDICAL DEVICES. 109 It is not within the scope of this standard to address contamination arising from the source of the - breathing gases entering such MEDICAL DEVICES, but rather only address the potential contamination - generated from within the MEDICAL DEVICE itself. This contamination might be from the original - manufacturing PROCESS or be generated by the MEDICAL DEVICE itself during use. - This part of ISO 18562 is concerned with substances that could be conveyed to the PATIENT by liquid - condensate forming in the MEDICAL DEVICE and then subsequently reaching the lungs of the PATIENT. - Potentially harmful substances that could be found in condensate include salts and metals. Condensate - management is part of most healthcare institution protocols, with the primary aim of preventing the - condensate reaching the PATIENT in the first place. The absolute volume of liquid reaching a PATIENT by - this route should therefore be low, but it might happen. This standard outlines tests for substances 119 contained in the liquid. - The methods to determine the acceptable levels of contamination are contained in Part 1 of thisĀ  standard.

Details

ICS-code 11.040.10
Nederlandse titel Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
Engelse titel Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate

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