BS EN ISO 8536-16:2025: Infusion Equipment for Medical Use

The BS EN ISO 8536-16:2025 is a comprehensive standard that outlines the specifications and requirements for infusion sets designed for single use with volumetric infusion controllers. This standard is essential for ensuring the safety, reliability, and efficiency of medical infusion equipment, which is critical in various healthcare settings.

Key Features and Specifications

• Standard Number: BS EN ISO 8536-16:2025
• Pages: 20
• Release Date: August 26, 2025
• ISBN: 978 0 539 29448 4
• Status: Standard

Overview of the Standard

This standard is part of the ISO 8536 series, which is dedicated to infusion equipment for medical use. The BS EN ISO 8536-16:2025 specifically focuses on infusion sets that are intended for single use and are equipped with volumetric infusion controllers. These devices are crucial in administering precise volumes of fluids, medications, or nutrients to patients, ensuring accurate and controlled delivery.

Importance of Volumetric Infusion Controllers

Volumetric infusion controllers are integral to modern medical practices, providing healthcare professionals with the ability to deliver fluids at a controlled rate. This is particularly important in critical care settings where precise fluid management is necessary. The infusion sets covered by this standard are designed to work seamlessly with these controllers, ensuring compatibility and performance.

Benefits of Compliance with BS EN ISO 8536-16:2025

Adhering to the BS EN ISO 8536-16:2025 standard offers numerous benefits, including:

• Enhanced Safety: The standard ensures that infusion sets meet stringent safety requirements, reducing the risk of complications during medical procedures.
• Quality Assurance: Compliance with the standard guarantees that the infusion sets are manufactured to high-quality specifications, ensuring reliability and durability.
• Global Recognition: As an internationally recognized standard, BS EN ISO 8536-16:2025 facilitates the acceptance and use of these infusion sets in healthcare facilities worldwide.
• Improved Patient Outcomes: By ensuring precise fluid delivery, the standard helps improve patient outcomes, particularly in critical care and surgical settings.

Who Should Use This Standard?

The BS EN ISO 8536-16:2025 standard is essential for a wide range of stakeholders in the healthcare industry, including:

• Medical Device Manufacturers: Companies involved in the production of infusion sets and related equipment must adhere to this standard to ensure their products meet international quality and safety benchmarks.
• Healthcare Providers: Hospitals, clinics, and other healthcare facilities should use infusion sets that comply with this standard to ensure the safety and well-being of their patients.
• Regulatory Bodies: Organizations responsible for the regulation and approval of medical devices can use this standard as a benchmark for evaluating the safety and efficacy of infusion equipment.

Conclusion

The BS EN ISO 8536-16:2025 standard is a vital document for ensuring the quality and safety of infusion sets used in medical settings. By providing clear guidelines and specifications, it helps manufacturers produce reliable products and assists healthcare providers in delivering safe and effective patient care. Whether you are a manufacturer, healthcare provider, or regulatory body, understanding and implementing this standard is crucial for maintaining high standards in medical infusion equipment.

BS EN ISO 8536-16:2025

This standard BS EN ISO 8536-16:2025 Infusion equipment for medical use is classified in these ICS categories:

• 11.040.20 Transfusion, infusion and injection equipment

This document specifies the requirements for sterilized, single-use, gravity feed infusion sets, used together with the volumetric infusion controllers of IEC 60601-2-24.