ISO/DIS 18562-1 : 60.00 (2017)被替代
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
Defines : - 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.
