Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2017)

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
5 Leachable substances in condensate
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 tests for substances leached by liquid water condensing into 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.

Committee	TC 121
DocumentType	Standard
Pages	26
ProductNote	The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD IS ALSO REFERS TO - USP 35 — NF 30, Chapter 233,USP 35 — NF 30, Chapter 232
PublisherName	National Standards Authority of Ireland
Status	Current

Standards	Relationship
EN ISO 18562-4:2020	Identical
ISO 18562-4:2017	Identical

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I.S. EN ISO 18562-4:2020

Current

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Abstract

General Product Information

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