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BSI 22/30437369 DC 2022

BSI 22/30437369 DC 2022

$13.70

BS EN ISO 18562-4. Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4. Tests for leachables in condensate

Published By Publication Date Number of Pages
BSI 2022 27
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PDF Catalog

PDF Pages PDF Title
1 30437369-NC.pdf
3 ISO_DIS 18562-4 ed.2 – id.82898 Enquiry PDF (en).pdf
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
11 4 General principles
4.1 Type tests
4.2 General
5 Leachables in condensate
5.1 Identifying applicable gas pathway surfaces
5.2 Determining if testing is required
12 5.3 Test methods
5.3.1 General
13 5.3.2 Sample collection
14 5.3.3 Chemical characterization of leachables in condensate
15 5.3.4 Calculation of tolerable exposure
5.3.5 Calculation of exposure dose estimate
5.3.6 Risk assessment
16 5.3.7 Biological evaluation according to ISO 10993 standards
17 6 Reporting
18 Annex€A (informative) Rationale and guidance
20 Annex€B (informative) Reference to the IMDRF essential principles and labelling guidances
21 Annex€C (informative) Reference to the essential principles
22 Annex€ZA (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
25 Bibliography
27 Terminology — Alphabetized index of defined terms

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BSI 22/30437369 DC 2022
$13.70