I.S. EN ISO 18562-4:2020
Current
The latest, up-to-date edition.
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2017)
Hardcopy , PDF
English
08-03-2020
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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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