ISO 28620-2020 PDF

Full title and description

ISO 28620:2020 — Medical devices — Non-electrically driven portable infusion devices. Specifies requirements and test methods for portable infusion devices that do not use electrical power and are intended for continuous or bolus delivery in clinical and non-clinical settings.

Abstract

This standard sets out essential safety and performance requirements and associated test methods for non-electrically driven portable infusion devices used for continuous (fixed or adjustable) flow and/or bolus neuraxial, intravascular or hypodermic applications. It covers devices intended for use by healthcare professionals or by patients and includes manufacturer-filled and user-filled devices, while excluding electrically driven pumps, implantable or enteral devices, transdermal systems and purely gravity-powered devices.

General information

• Status: Published
• Publication date: 16 January 2020
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.20
• Edition / version: Edition 2 (2020)
• Number of pages: 12

Scope

Applies to non-electrically driven portable infusion devices designed for continuous or bolus delivery in neuraxial, intravascular or hypodermic applications used in both healthcare and non-healthcare settings. The standard does not apply to electrically driven or electrically controlled infusion pumps (covered by IEC 60601‑2‑24), single-use bolus delivery devices covered by the ISO 11608 series, implantable devices, enteral or transdermal delivery systems, or devices where infusion energy is entirely external (for example gravity-only systems).

Key topics and requirements

• Essential safety and performance requirements for non-electrically driven portable infusion devices.
• Test methods to verify flow rates, accuracy, leakage, mechanical integrity and device durability.
• Requirements for user information, labeling and instructions for use to ensure safe application by clinicians and patients.
• Risk-reduction measures related to unintended bolus, occlusion, and backflow.
• Distinctions and exclusion clauses clarifying applicability relative to electrically driven pumps and other delivery technologies.

Typical use and users

Used by medical device manufacturers, regulatory and compliance teams, clinical engineers, purchasing departments and healthcare providers evaluating or designing non‑electrically driven infusion devices. Also referenced by hospitals, home‑care providers and test laboratories for product assessment and conformity verification.

Related standards

Related and referenced documents include IEC 60601‑2‑24 (electrically driven infusion pumps), the ISO 11608 series (single‑use bolus delivery systems), and outputs from ISO/TC 76. The 2020 edition replaces ISO 28620:2010.

Keywords

infusion device, portable infusion, non-electrically driven, medical device, neuraxial infusion, continuous infusion, bolus delivery, device testing, ISO 28620

FAQ

Q: What is this standard?

A: ISO 28620:2020 is an international standard specifying safety, performance and test method requirements for non‑electrically driven portable infusion devices used to deliver medicinal products via continuous or bolus administration.

Q: What does it cover?

A: It covers design and testing requirements for non‑electrically driven portable infusion devices (continuous and bolus), labeling and user information, and excludes electrically driven pumps, implantable/enteral/transdermal systems and gravity‑only devices.

Q: Who typically uses it?

A: Medical device manufacturers, regulatory affairs and quality teams, testing laboratories, hospital procurement and clinical engineering groups, and home‑care product developers.

Q: Is it current or superseded?

A: Current — ISO 28620:2020 (Edition 2) was published in January 2020 and supersedes ISO 28620:2010.

Q: Is it part of a series?

A: It stands as a single product standard for non‑electrically driven portable infusion devices but references related series and standards (for example ISO 11608 series for single‑use bolus delivery devices) and sits within the ISO/TC 76 medical devices portfolio.

Q: What are the key keywords?

A: Infusion, portable infusion device, non‑electrically driven, continuous infusion, bolus delivery, medical device safety, flow accuracy, ISO 28620.