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ISO 80369-3 / ISO

Enteral applications

Connectors for enteral medical devices and accessories.

Browse product typesReview test methods
ISO 80369-3:2016 + Amd 1:2019 Enteral applications product and test method context
Selection path

Move from the standard to a reviewed product path

Start with enteral connector side, then select reference connector and ISO 80369-20 method.

  • Standard
  • Application
  • Connector
  • Figure or Annex
  • Product Type
  • Product
  • Test Method
  • Equipment or Fixture
  • Calibration
  • Evidence
  • Page
Registry facts

Application, connector and evidence fields

Fields marked pending need engineering review before they become product claims.

Field
Current registry value
Product implication
Review state
Edition

2016, Edition 1; Amendment 1:2019; confirmed 2023

Published

verified_public_source

Connector designation

enteral connector family

Use figure-specific reference connector only when product evidence exists.

standard_fact

Figures or annexes

figure or annex mapping pending product review

Fixture selection depends on method and sample interface.

verified_public_source

Gauge

No gauge assumption unless a gauge product record exists.

Calibration route depends on item type and certificate wording.

verified_public_source

Complete system

Complete setup combines standard, product, method, equipment, fixture and documents.

pressure equipment, force equipment, torque equipment, fixtures

standard_fact

Product type routing

Choose by what the buyer needs to select

Reference Connectors

Match a sample connector to the figure-defined reference interface needed for functional testing.

standard part / figure or annex / male or female / slip or lock / rigid or semi-rigid / certificate expectation

Gauges and Gauge Sets

Inspect Luer dimensional or fit conditions without confusing gauges with reference connectors.

checked sample side / ring or plug / lock or slip / individual gauge or set / certificate wording

ISO 80369-20 Test Equipment

Select the instrument path by measured action: leakage, force, torque, overriding or stress cracking.

method annex / pressure or force or torque channel / fixture / sample side / report requirement

Fixtures and Assembly Devices

Hold, align or assemble the connector pair so the chosen method can be repeated.

sample geometry / mating counterpart / axial or side load / torque interface / method annex

Complete Test Systems

Quote multiple items as one reviewed setup when the buyer needs method coverage rather than a single part.

standard part / method group / reference connectors / fixtures / equipment / calibration route

Calibration and Recertification

Choose the right verification or certificate route for gauges, reference connectors and instrument channels.

item type / measured feature / traceability wording / third-party accredited lab option / recertification interval

Representative products and methods

Open product samples or method groups from this standard

Leakage and pressure

Leakage methods

Pressure decay, positive-pressure liquid leakage or subatmospheric-pressure air leakage.

Mechanical separation

Separation and axial load methods

Resistance to separation from axial load and related mechanical setup.

Torque and lock-interface behavior

Torque and unscrewing methods

Unscrewing, overriding or related torque-channel behavior.

Material and environmental resistance

Stress cracking method

Stress cracking evaluation for connector condition after exposure and assembly context.

Evidence

Source records used by this page