I.S. EN ISO 20695:2020
Current
The latest, up-to-date edition.
Enteral feeding systems - Design and testing (ISO 20695:2020)
Hardcopy , PDF
English
04-26-2020
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.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Additional requirements for enteral giving sets and enteral extension sets
6 Additional requirements for enteral syringes
7 Additional requirements for enteral feeding catheters
8 Additional requirements for enteral accessories
Annex A (informative) Rationale and guidance
Annex B (normative) Test method for corrosion resistance of metallic components
Annex C (normative) Test method for tensile properties
Annex D (normative) Test method for resistance to liquid leakage under pressure
Annex E (normative) Test method for determining the flow rate
Annex F (normative) Test method for determining the designated outer diameter of enteral feeding catheters
Annex G (normative) Test method for determining balloon burst volume
Annex H (normative) Test method for determining balloon inflation system performance
Annex I (normative) Test method for determining balloon concentricity
Annex J (normative) Test method for determining balloon integrity in simulated gastric fluid
Annex K (informative) Example of an alternative enteral syringe tip
Bibliography
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