ISO 8536-4-2019 PDF

Full title and description

Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed. This international standard specifies requirements for single-use, gravity-feed infusion sets to ensure their compatibility with infusion solution containers and intravenous equipment, and provides guidance on material quality, performance and component designations.

Abstract

ISO 8536-4:2019 sets out designations and essential requirements for disposable gravity-feed infusion sets used in medical settings, including guidance on materials and performance to promote interchangeability and safe use with containers and IV equipment. The standard aims to standardize terminology and provide minimum quality and performance expectations for manufacturers, regulators and users.

General information

• Status: Published (current; last reviewed and confirmed in 2025).
• Publication date: 18 September 2019.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.20 (Transfusion, infusion and injection equipment).
• Edition / version: Edition 6 (2019).
• Number of pages: 18.

(General information above is taken from the ISO bibliographic record for ISO 8536-4:2019.)

Scope

ISO 8536-4:2019 applies to single-use infusion sets intended to be used by gravity feed. It specifies requirements to ensure compatibility of infusion sets with containers for infusion solutions and with other intravenous equipment. The scope also covers guidance on specifications for the quality and performance of materials used in infusion sets and provides standardized designations for components of infusion sets.

Key topics and requirements

• Requirements for compatibility between infusion sets and containers/IV equipment (mechanical fit and functional interchangeability).
• Guidance and requirements on materials used in fluid-contacting parts to ensure safety and performance (quality, biocompatibility considerations and performance characteristics).
• Standardized designations and terminology for infusion-set components to improve clarity across manufacturers and users.
• Design and performance considerations for gravity-feed flow characteristics, connectors and closures (general requirements and testing expectations implied by the standard’s scope).
• Marking, labelling and packaging expectations to support safe single-use medical practice and traceability.

Typical use and users

Primary users include medical device manufacturers (design and compliance teams), regulatory bodies and conformity assessment organizations, hospital procurement and clinical engineering departments, and quality assurance teams responsible for device selection and validation. Clinicians and nursing staff rely on the interoperability and labeling standardized by this type of standard when selecting and using infusion sets.

Related standards

ISO 8536-4:2019 is part of the ISO 8536 series (Infusion equipment for medical use), which includes multiple parts covering infusion bottles, closures, burette infusion sets, pressure-infusion equipment, fluid lines and related accessories. EN ISO 8536-4:2020 is effectively identical/adopted at the European level. The ISO 8536 series and regional adoptions provide complementary, harmonized specifications across parts.

Keywords

infusion set, gravity feed, single-use, infusion equipment, medical device, ISO 8536, compatibility, materials performance, component designation, ISO/TC 76

FAQ

Q: What is this standard?

A: ISO 8536-4:2019 is an international standard specifying requirements for single-use, gravity-feed infusion sets used in medical settings, including guidance on materials, performance and component designations.

Q: What does it cover?

A: It covers compatibility with infusion containers and intravenous equipment, material-quality and performance guidance for fluid-contacting parts, and standardized names/designations for infusion-set components; it also implies relevant design, labelling and testing expectations for safe single-use gravity infusion sets.

Q: Who typically uses it?

A: Manufacturers, regulatory authorities, conformity assessment bodies, hospital procurement and clinical engineering teams, QA/RA professionals, and clinicians involved in selecting and using infusion sets.

Q: Is it current or superseded?

A: ISO 8536-4:2019 is the current published edition (published 18 September 2019) and the ISO bibliographic record shows it was reviewed and confirmed as current in 2025. It replaced earlier editions (for example the 2010 edition).

Q: Is it part of a series?

A: Yes — it is one part of the ISO 8536 series, which covers multiple aspects of infusion equipment for medical use (other parts address bottles, closures, burette sets, pressure-infusion equipment, fluid lines and accessories).

Q: What are the key keywords?

A: infusion set, single-use, gravity feed, compatibility, materials performance, component designation, ISO 8536, medical device.