Norm

ISO/DIS 18562-1:2015 en

Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 1: Evaluation and testing within a risk management process

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Over deze norm

Status Ontwerp
Aantal pagina's 34
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 12-11-2015
Taal Engels
This part of ISO 18562 specifies:  - the general principles governing the biological evaluation within a RISK MANAGEMENT PROCESS of the  GAS PATHWAYS of a MEDICAL DEVICE, its parts or ACCESSORIES, which are intended to provide respiratory -  care to a PATIENT in all environments; - the general categorization of GAS PATHWAYS based on the nature and duration of their contact with - the gas stream; -  the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a RISK ANALYSIS; -  the identification of additional data sets necessary to analyse the biological safety of the GAS -  PATHWAY; and - the assessment of the biological safety of the GAS PATHWAY. - This first part of ISO 18562 covers general principles regarding BIOCOMPATIBILITY assessment of MEDICAL -  DEVICE materials, which make up the GAS PATHWAY, but does not cover biological HAZARDS arising from -  any mechanical failure, unless the failure introduces a toxicity RISK (e.g. by generating PARTICULATES). -  The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are - added to the respirable gas stream and establish acceptance criteria for these substances. -  This International Standard addresses potential contamination of the gas stream arising from the GAS 167 PATHWAYS within the MEDICAL DEVICE, which might then be conducted to the PATIENT. -  This International 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 MEDICAL DEVICES -  that are in direct contact with the PATIENT. The requirements for direct contact surfaces are found in -  ISO 10993 (series).

Details

ICS-code 11.040.10
Nederlandse titel Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 1: Evaluation and testing within a risk management process
Engelse titel Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 1: Evaluation and testing within a risk management process

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