BS EN ISO 8536-4:2020 Infusion Equipment for Medical Use

Infusion Sets for Single Use, Gravity Feed

The BS EN ISO 8536-4:2020 is a comprehensive standard that outlines the specifications and requirements for infusion equipment used in medical settings. This standard is specifically focused on infusion sets designed for single use with gravity feed systems. Released on March 17, 2020, this document is an essential resource for healthcare professionals and manufacturers who are committed to ensuring the highest quality and safety in medical infusion equipment.

Key Features and Benefits

• Standard Number: BS EN ISO 8536-4:2020
• Pages: 26
• Release Date: March 17, 2020
• ISBN: 978 0 539 13337 0
• Status: Standard

This standard is crucial for ensuring that infusion sets meet the necessary safety and performance criteria. It provides detailed guidelines on the design, materials, and testing methods required to produce reliable and effective infusion sets. By adhering to these standards, manufacturers can ensure that their products are safe for use in medical environments, thereby protecting both patients and healthcare providers.

Why Choose BS EN ISO 8536-4:2020?

The BS EN ISO 8536-4:2020 standard is recognized globally for its rigorous approach to quality assurance in medical infusion equipment. It is designed to help manufacturers produce infusion sets that are not only safe and effective but also compliant with international regulations. This standard is an invaluable tool for anyone involved in the production, testing, or use of medical infusion equipment.

Comprehensive Guidelines

The document spans 26 pages, providing a thorough overview of the requirements for infusion sets. It covers everything from the materials used in production to the testing methods required to ensure product safety and efficacy. This level of detail ensures that all aspects of infusion set production are covered, leaving no room for error or oversight.

Global Recognition

As a part of the ISO standards, BS EN ISO 8536-4:2020 is recognized and respected worldwide. This means that products manufactured in compliance with this standard are suitable for use in a wide range of international markets. This global recognition not only enhances the credibility of the products but also opens up new opportunities for manufacturers looking to expand their reach.

Ensuring Patient Safety

Patient safety is of paramount importance in any medical setting. By following the guidelines set out in BS EN ISO 8536-4:2020, manufacturers can ensure that their infusion sets are safe for use, reducing the risk of complications or adverse reactions. This commitment to safety is crucial for maintaining trust and confidence in medical products.

Who Should Use This Standard?

The BS EN ISO 8536-4:2020 standard is designed for a wide range of stakeholders in the medical field. This includes:

• Manufacturers: Companies involved in the production of medical infusion equipment will find this standard invaluable for ensuring their products meet the necessary safety and quality criteria.
• Healthcare Providers: Medical professionals can use this standard to verify that the equipment they use meets international safety standards, ensuring the best possible care for their patients.
• Regulatory Bodies: Organizations responsible for overseeing the safety and efficacy of medical products can use this standard as a benchmark for compliance and quality assurance.

Conclusion

The BS EN ISO 8536-4:2020 standard is an essential resource for anyone involved in the production, testing, or use of medical infusion equipment. Its comprehensive guidelines ensure that infusion sets are safe, effective, and compliant with international regulations. By adhering to this standard, manufacturers can enhance the quality of their products, healthcare providers can ensure the safety of their patients, and regulatory bodies can maintain high standards of medical care.

Investing in the BS EN ISO 8536-4:2020 standard is a step towards ensuring the highest quality and safety in medical infusion equipment. Whether you are a manufacturer, healthcare provider, or regulatory body, this standard provides the guidance and assurance needed to excel in the field of medical infusion technology.

BS EN ISO 8536-4:2020

• 11.040.20 Transfusion, infusion and injection equipment

This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.

Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.