Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
Also Known As:
SKU196426586
Published by
Deutsches Institut für Normung
DIN
Publication Date2020-05
Pages CountPages33
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.
Details
| Descriptors | Anaesthetic equipment, Atomizers, Biocompatibility, Breathing, Breathing apparatus, Breathing equipment, Breathing masks, Breathing tubes, Contamination, Definitions, Evaluations, Gas stream, Hazard analysis, Hazards, Health hazards, Humidifiers, Incubators, Inhaled air, Medical devices, Medical equipment, Medical gases, Medical sciences, Oxygen concentration, Oxygen hose, Oxygen supply, Patient protection, Patients, Respiration, Respiratory system, Respiratory tracts, Respired gases, Resuscitators, Risk management, Testing, Tracheal tubes, Medical products |
| ICS Codes | 11.040.10 - Anaesthetic, respiratory and reanimation equipment |
| Language(s) | English |
| File Size | 2.4 MB |
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