BS EN ISO 1135-5:2025 - Transfusion Equipment for Medical Use

Introducing the BS EN ISO 1135-5:2025, a comprehensive standard that sets the benchmark for transfusion equipment designed for medical use. This standard specifically focuses on transfusion sets intended for single use with pressure infusion apparatus, ensuring the highest level of safety and efficiency in medical settings.

Key Features

• Standard Number: BS EN ISO 1135-5:2025
• Pages: 40
• Release Date: December 11, 2025
• ISBN: 978 0 539 19876 8
• Status: Standard

Overview

The BS EN ISO 1135-5:2025 standard is an essential document for healthcare professionals and manufacturers involved in the production and use of transfusion equipment. It provides detailed guidelines and specifications to ensure that transfusion sets are safe, reliable, and effective when used with pressure infusion apparatus.

Why Choose BS EN ISO 1135-5:2025?

This standard is crucial for maintaining the integrity and safety of blood transfusion processes. By adhering to the guidelines set forth in BS EN ISO 1135-5:2025, healthcare providers can minimize risks associated with transfusion procedures, thereby enhancing patient safety and care quality.

Comprehensive Guidelines

The document spans 40 pages, offering a thorough exploration of the requirements and specifications for transfusion sets. It covers various aspects, including materials, design, performance, and testing methods, ensuring that all equipment meets the highest standards of quality and safety.

Up-to-Date Standards

Released on December 11, 2025, this standard reflects the latest advancements and best practices in the field of medical transfusion equipment. It is designed to keep pace with technological innovations and evolving healthcare needs, making it a vital resource for modern medical practices.

Global Recognition

As part of the ISO (International Organization for Standardization) family, BS EN ISO 1135-5:2025 is recognized and respected worldwide. It provides a common framework that facilitates international collaboration and ensures consistency in the quality of transfusion equipment across different regions.

Applications

The BS EN ISO 1135-5:2025 standard is applicable to a wide range of medical settings, including hospitals, clinics, and emergency care facilities. It is particularly relevant for:

• Healthcare professionals involved in blood transfusion procedures
• Manufacturers of medical transfusion equipment
• Regulatory bodies overseeing medical device compliance

Benefits of Compliance

Compliance with BS EN ISO 1135-5:2025 offers numerous benefits, including:

• Enhanced Patient Safety: By following the standard's guidelines, healthcare providers can significantly reduce the risk of transfusion-related complications.
• Improved Equipment Reliability: The standard ensures that transfusion sets are manufactured to the highest quality, providing reliable performance in critical medical situations.
• Regulatory Compliance: Adhering to this standard helps manufacturers meet regulatory requirements, facilitating market access and acceptance.
• International Compatibility: The global recognition of the standard ensures that equipment is compatible with international practices, promoting seamless cross-border healthcare delivery.

Conclusion

The BS EN ISO 1135-5:2025 standard is an indispensable resource for anyone involved in the field of medical transfusion equipment. Its comprehensive guidelines and specifications ensure that transfusion sets are safe, effective, and reliable, ultimately enhancing the quality of patient care. By choosing to comply with this standard, healthcare providers and manufacturers can demonstrate their commitment to excellence and patient safety.

BS EN ISO 1135-5:2025

This standard BS EN ISO 1135-5:2025 Transfusion equipment for medical use is classified in these ICS categories:

• 11.040.20 Transfusion, infusion and injection equipment

This document specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures. It ensures compatibility with containers for blood and blood components as well as intravenous equipment. This document also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with red cell and plasma blood components. NOTE            In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.