This document 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 or supply substances via the respiratory tract 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;
— the assessment of the biological safety of the gas pathway.
This document 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 document addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be conducted to the patient.
This document applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing.
Cross References:ISO 7396-1:2016
ISO 14971:2007
ISO 10993-1:2009
ISO 18562-3
ISO 18562-2
ISO 10993-17:2002
ISO 18562-4
ISO 10993-13
ISO 10993-15
BS 5724-3.12
ISO 10993-14
ISO 10993-9
IEC 60601-1:2005
IEC 17025
A1:2012
ISO 16142-1:2016
ISO 13485:2016
Incorporates the following:Corrigendum, February 2020
| File Size : | 1
file
, 4.6 MB |
| ISBN(s) : | 9780539045055 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 32 |
| Product Code(s) : | 30394146, 30394146, 30394146 |
| Published : | 02/19/2020 |
| Same As : | BS EN ISO 18562-1:2020 |
