ISO 18562-1:2017作廢
Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process
出版：International Organization for Standardization
專家解讀視頻
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.
BS ISO 18562-1 : 2017 - Identical
NF ISO 18562-1 : 2017 - Identical
NEN ISO 18562-1 : 2017 - Identical
DS ISO 18562-1 : 2017 - Identical
NF ISO 18562-1 : 2017 - Identical
DS ISO 18562-1 : 2017 - Identical
NEN ISO 18562-1 : 2017 - Identical
BS ISO 18562-1 : 2017 - Identical
