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BS EN ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications - Connectors for enteral applications >
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BS EN ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications - Connectors for enteral applications, 2016
- Contents Page
- European foreword
- Table — Correlations between normative references and dated EN and ISO/IEC standards
- 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
- Table ZA.2 — Relevant Essential Health and Safety Requirements (EHSRs) from Directive 2006/42/EC on machinery that are addressed by this document
- Foreword
- Introduction
- 1 * Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements
- 4.1 General requirements for the enteral application
- 4.2 Material used for enteral small-bore connectors
- 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
- 6.4 Resistance to separation from unscrewing
- 6.5 Resistance to overriding
- 6.6 Disconnection by unscrewing
- Annex A (informative) Rationale and guidance
- Annex B (normative) Enteral small-bore connectors
- Annex C (normative) Reference connectors
- Annex D (informative) Assessment of medical devices and their attributes with connections within this application
- Annex E (informative) Summary of the usability requirements for small-bore connectors for enteral applications
- Annex F (informative) Summary of small-bore connector criteria and requirements for enteral applications
- Annex G (informative) Summary of assessment of the design of the connectors for enteral applications
- Annex H (informative) Reference to the essential principles
- Annex I (informative) Terminology — Alphabetized index of defined terms
- Bibliography [Go to Page]
