Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 General principles applying to <br>&nbsp;&nbsp;BIOCOMPATIBILITY evaluation of MEDICAL DEVICES<br>5 Contamination of breathing gas from GAS <br>&nbsp;&nbsp;PATHWAYS<br>6 Adjustment for different PATIENT groups<br>7 Deriving allowable limits<br>8 RISK benefit analysis<br>9 Assess the BIOCOMPATIBILITY of the MEDICAL DEVICE<br>Annex A (informative) - Rationale and guidance<br>Annex B (informative) - Reference to the essential principle<br>Annex C (informative) - Terminology - Alphabetized <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;index of defined terms<br>Bibliography

Abstract

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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 121
Supersedes	ISO/DIS 18562-1 : 60.00 (2017)