DIN EN ISO 18562-1:2020 Edition

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Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process

Published By	Publication Date	Number of Pages
DIN	2020-05	33

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Categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment, DIN

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Description

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.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2020-05
Pages Count	33
Language	Germany
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
File Size	2.4 MB
ICS Codes	11.040.10 - Anaesthetic, respiratory and reanimation equipment

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DIN EN ISO 18562-1:2020 Edition

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