ISO 18250-3:2018

Overview

ISO 18250-3:2018 - Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications specifies dimensional and functional requirements for enteral reservoir connectors. The standard defines two connector designs (E1R and E2R), material stiffness requirements, dimensional tolerances, and type-test performance criteria to reduce the risk of misconnections (for example with intravenous systems). It applies to connectors intended for enteral reservoirs and complements device-specific standards rather than replacing them.

Key topics and requirements

• Scope and purpose: Defines connector geometry and performance for enteral reservoirs; encourages manufacturers to adopt these connectors to improve safety and interoperability.
• Connector types: Two designs covered - cross-type connectors (E1R) and male/female types (E2R) with dimensional details in Annex B (figures and tables).
• Materials: Reservoir connector materials shall have a modulus of elasticity > 700 MPa (rigid/semi-rigid); softer sealing materials are allowed if they do not compromise non-interconnectability.
• Non-interconnectability: Design and verification requirements to prevent unintended mating with other medical device ports (e.g., IV bag ports).
• Dimensional verification: Compliance checked against specified figures/tables for each connector design (Annex B) and reference connectors (Annex C).
• Performance (type) tests - referenced methods and example requirements:
  • Positive pressure liquid leakage: no visible leakage at 40–60 kPa over ~30–35 s (torque 0.08–0.10 N·m per ISO 80369-20 Annex C).
  • Subatmospheric air leakage: maximum leakage limit specified (test at ~4.0–4.8 kPa, hold 15–20 s; see ISO 80369-20 Annex D).
  • Stress cracking, axial separation, unscrewing and override resistance: test procedures referenced to ISO 80369-20 (Annexes E–F); axial disconnection load example 32–35 N (hold 10–15 s).
• Guidance and usability: Informative annexes provide rationale, usability summaries and assessment guidance (Annexes A, D–G).
• Exclusions: Screw and crown cork caps/necks (food/beverage packaging standards) are outside this standard’s scope.

Applications and who uses it

• Medical device manufacturers designing enteral reservoirs, feeding bags and connectors should use ISO 18250-3 to ensure safe, non-interconnectable interfaces.
• Product designers and R&D teams for tubing, pumps and enteral accessories seeking dimensional and performance compatibility.
• Regulatory and quality engineers for product compliance, risk mitigation and design verification.
• Test laboratories performing type tests referenced to ISO 80369-20 and ASTM/ISO material tests.
• Procurement and healthcare providers evaluating device interoperability and safety.

Related standards

• ISO 18250-1 (general requirements)
• ISO 80369-20 (common test methods)
• ISO 80369-3 (small-bore enteral connectors)
• ASTM D638-10, ASTM D790-10 (material test methods)
• Relevant DIN / ISO / EN standards for caps and necks (listed in the standard)

Keywords: ISO 18250-3:2018, enteral connectors, reservoir connectors, medical device connectors, non-interconnectable, leakage test, dimensional requirements, ISO 80369-20.