I.S. EN ISO 18562-1:2020

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to biocompatibility evaluation of medical devices
5 Contamination of breathing gas from gas pathways
6 Adjustment for different patient groups
7 * Deriving allowable limits
8 Risk benefit analysis
9 Assess the biocompatibility of the medical device
Annex A (informative) Rationale and guidance
Annex B (informative) Reference to the essential principles
Annex C (informative) Terminology — Alphabetized index of defined terms
Bibliography

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.