Norm

ISO/DIS 18562-2:2015 en

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter

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Over deze norm

Status Ontwerp
Aantal pagina's 23
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 - amounts of PARTICULATE MATTER that arises from within of breathing GAS PATHWAYS of MEDICAL DEVICES. - 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. For example, the ISO 10993 tests do not evaluate inspired PARTICULATE 113 MATTER. - 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 address only 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 PARTICULATE MATTER that could be conveyed to the PATIENT by - the breathing gases. The smaller the particle the deeper into the lungs it can penetrate and the longer it - takes the body to eliminate it. Originally, the main health concerns with regard to PARTICULATE MATTER - were focussed on respiratory health, but now there is emerging evidence of effects on the - cardiovascular system as well. - The tests for the presence of PARTICULATE MATTER generated by respiratory MEDICAL DEVICES are based on - standard laboratory practice and require no advanced techniques or equipment. - The acceptable levels of contamination are based on worldwide-published health data for particulates. - It is accepted that there is no point in setting levels that are lower than that found in air that people - might breathe every day of their lives.

Details

ICS-code 11.040.10
Nederlandse titel Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
Engelse titel Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter

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