BS EN ISO 1135-4:2025 Transfusion Equipment for Medical Use

Transfusion Sets for Single Use, Gravity Feed

Introducing the BS EN ISO 1135-4:2025, the latest standard in transfusion equipment for medical use. This comprehensive document is essential for healthcare professionals and institutions that prioritize safety, efficiency, and compliance in blood transfusion procedures. Released on December 11, 2025, this standard is the definitive guide for transfusion sets designed for single use with gravity feed systems.

Key Features and Benefits

• Standard Number: BS EN ISO 1135-4:2025
• Pages: 34
• ISBN: 978 0 539 19874 4
• Status: Standard

The BS EN ISO 1135-4:2025 standard is meticulously crafted to ensure that transfusion sets meet the highest quality and safety standards. It provides detailed specifications and guidelines that are crucial for the design, production, and testing of transfusion sets. This ensures that healthcare providers can deliver blood products safely and effectively, minimizing the risk of complications and enhancing patient outcomes.

Comprehensive Coverage

Spanning 34 pages, this standard offers an in-depth exploration of the requirements for transfusion sets. It covers a wide range of topics, including materials, design, performance, and testing methods. Each section is designed to provide clear and concise information, making it easier for manufacturers and healthcare providers to adhere to the best practices in transfusion technology.

Why Choose BS EN ISO 1135-4:2025?

The BS EN ISO 1135-4:2025 standard is an invaluable resource for anyone involved in the production or use of transfusion equipment. By adhering to this standard, you can ensure that your products meet international quality and safety benchmarks. This not only enhances the reputation of your healthcare facility but also provides peace of mind to patients and their families.

Single Use, Gravity Feed: The focus on single-use, gravity feed transfusion sets is particularly important in today's healthcare environment. Single-use sets reduce the risk of cross-contamination and infection, while gravity feed systems offer a reliable and straightforward method for administering blood products. This standard provides the necessary guidelines to optimize these systems for maximum efficiency and safety.

Global Relevance

As a part of the ISO standards, BS EN ISO 1135-4:2025 is recognized and respected worldwide. This ensures that your transfusion equipment is compliant with international regulations, facilitating easier market access and acceptance across different countries. Whether you are a manufacturer looking to expand your market reach or a healthcare provider aiming to maintain the highest standards of care, this standard is an essential tool.

Invest in Quality and Safety

Investing in the BS EN ISO 1135-4:2025 standard is an investment in quality and safety. It empowers healthcare providers to deliver the best possible care, backed by equipment that meets rigorous international standards. By implementing the guidelines outlined in this standard, you can enhance the safety and effectiveness of blood transfusion procedures, ultimately improving patient care and outcomes.

Conclusion

The BS EN ISO 1135-4:2025 standard is a critical resource for anyone involved in the field of transfusion medicine. Its comprehensive guidelines ensure that transfusion sets are designed and manufactured to the highest standards, promoting safety and efficiency in medical settings. With its global recognition and detailed coverage, this standard is an indispensable tool for enhancing the quality of transfusion equipment and procedures.

Ensure your transfusion equipment meets the highest standards of safety and quality with the BS EN ISO 1135-4:2025. Embrace the future of transfusion technology and provide your patients with the care they deserve.

BS EN ISO 1135-4:2025

This standard BS EN ISO 1135-4:2025 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 gravity sets for medical use to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. It also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, presents designations for transfusion set components, and ensures the compatibility of sets with a range of cellular and plasma blood components. NOTE            In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.