DSF/ISO/DIS 18562-1
Biocompatibility evaluation of breathing gas pathways in healthcare applications-- Part 1: Evaluation and testing within a risk management process
inactive, Most Current
| Organization: | DS |
| Status: | inactive |
| Page Count: | 35 |
| ICS Code (Anaesthetic, respiratory and reanimation equipment): | 11.040.10 |
scope:
This part of ISO 18562 specifies: ¾ 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; ¾ the general categorization of GAS PATHWAYS based on the nature and duration of their contact with the gas stream; ¾ the evaluation of existing relevant data from all sources; ¾ the identification of gaps in the available data set on the basis of a RISK ANALYSIS; ¾ the identification of additional data sets necessary to analyse the biological safety of the GAS PATHWAY; and ¾ the assessment of the biological safety of the GAS PATHWAY.
Document History
DSF/ISO/DIS 18562-1
Biocompatibility evaluation of breathing gas pathways in healthcare applications-- Part 1: Evaluation and testing within a risk management process
This part of ISO 18562 specifies: ¾ the general principles governing the biological evaluation within a RISK MANAGEMENT PROCESS of the GAS PATHWAYS of a MEDICAL DEVICE, its parts or ACCESSORIES,...