Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2017)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

03-08-2020

Publisher

National Standards Authority of Ireland

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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.

Committee	TC 121
DocumentType	Standard
Pages	40
ProductNote	The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
PublisherName	National Standards Authority of Ireland
Status	Current

Standards	Relationship
ISO 18562-1:2017	Identical
EN ISO 18562-1:2020	Identical

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I.S. EN ISO 18562-1:2020

Current

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Abstract

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