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BS EN ISO 80369-3:2016+A1:2019:2023 Edition

BS EN ISO 80369-3:2016+A1:2019:2023 Edition

$39.73

Small-bore connectors for liquids and gases in healthcare applications – Connectors for enteral applications

Published By Publication Date Number of Pages
BSI 2023 52
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PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
5 Table — Correlations between normative references and dated EN and ISO/IEC standards
6 Annex ZA (informative) Relationship between this document and the Essential Requirements of EU Directive 93/42/EEC
Table ZA.1 — Correspondence between this document and Directive 93/42/EEC
7 Table ZA.2 — Relevant Essential Health and Safety Requirements (EHSRs) from Directive 2006/42/EC on machinery that are addressed by this document
8 Blank Page
10 Foreword
11 Introduction
13 1 * Scope
2 Normative references
14 3 Terms and definitions
15 4 General requirements
4.1 General requirements for the enteral application
4.2 Material used for enteral small-bore connectors
16 4.3 Type tests
5 Dimensional requirements for enteral small-bore connectors
6 Performance requirements
6.1 Fluid leakage
6.1.1 Fluid leakage requirement
6.1.2 Leakage by pressure decay
6.1.3 Positive pressure liquid leakage
6.2 Stress cracking
6.3 Resistance to separation from axial load
17 6.4 Resistance to separation from unscrewing
6.5 Resistance to overriding
6.6 Disconnection by unscrewing
18 Annex A (informative) Rationale and guidance
22 Annex B (normative) Enteral small-bore connectors
28 Annex C (normative) Reference connectors
33 Annex D (informative) Assessment of medical devices and their attributes with connections within this application
34 Annex E (informative) Summary of the usability requirements for small-bore connectors for enteral applications
39 Annex F (informative) Summary of small-bore connector criteria and requirements for enteral applications
42 Annex G (informative) Summary of assessment of the design of the connectors for enteral applications
48 Annex H (informative) Reference to the essential principles
50 Annex I (informative) Terminology — Alphabetized index of defined terms
51 Bibliography

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BS EN ISO 80369-3:2016+A1:2019
$39.73