ISO 28620:2020

Overview

ISO 28620:2020 - Medical devices - Non-electrically driven portable infusion devices - specifies essential requirements and test methods for portable infusion devices that do not use electrical power. It covers devices intended for continuous (fixed or adjustable) flow and/or bolus delivery for neuraxial and intravascular/hypodermic applications. The standard applies to devices used in healthcare and non‑healthcare settings, whether filled by the manufacturer, a clinician or the patient.

Key topics and requirements

• Scope exclusions: does not apply to electrically driven pumps (IEC 60601‑2‑24), implantable devices, enteral or transdermal delivery systems, single‑bolus devices covered by ISO 11608, or gravity‑only systems.
• Core components: must include a means to convert non‑electric energy to fluid flow, a flow restrictor, a reservoir and a particulate filter. Additional features may include adjustable flow systems, filling ports, lock connectors, clamps, bolus systems, tubing and air‑elimination features.
• Materials and biocompatibility: materials in contact with drug solutions require biological evaluation in accordance with ISO 10993‑1.
• Connectors and fittings: fittings must conform to ISO 80369‑1, and where applicable ISO 80369‑6 (neuraxial) and ISO 80369‑7 (intravascular/hypodermic).
• Filter performance: particulate filter retention when tested per the standard shall be not less than 80% for latex particles.
• Design and performance: device design must meet declared nominal flow rate, mean and instantaneous flow characteristics, bolus volume and refill time requirements.
• Testing methods: includes procedures for determination of flow rate, resistance to pressure, drop testing, water‑tightness, resistance to traction, bolus volume, refill time and fluid filter efficiency.
• Labelling and documentation: requirements for marking, nominal volumes, nominal bolus/refill times, packaging information and accompanying instructions for use.

Applications and users

ISO 28620:2020 is used by:

• Medical device manufacturers designing and validating non‑electrically driven infusion devices (wearable or portable infusion systems).
• Design and quality engineers for establishing performance and testing protocols.
• Regulatory and compliance teams preparing technical documentation for market approval.
• Test laboratories conducting conformity and performance testing per specified methods.
• Healthcare procurement and clinical staff evaluating device suitability for neuraxial or intravascular therapy in hospital, outpatient or home care settings.

Related standards

• ISO 10993‑1 - Biological evaluation of medical devices
• ISO 80369‑1, ‑6, ‑7 - Small‑bore connectors for healthcare applications
• IEC 60601‑2‑24 and ISO 11608 series (not covered by ISO 28620; referenced for excluded device types)

Keywords: ISO 28620:2020, non‑electrically driven portable infusion devices, infusion device standards, neuraxial infusion, intravascular infusion, flow rate testing, filter efficiency, ISO 80369, ISO 10993‑1.