BS EN ISO 8536-12:2021 Infusion Equipment for Medical Use - Check Valves for Single Use

Introducing the BS EN ISO 8536-12:2021, a comprehensive standard that sets the benchmark for infusion equipment used in medical settings, specifically focusing on check valves designed for single use. This standard is an essential resource for manufacturers, healthcare professionals, and regulatory bodies involved in the production and utilization of medical infusion equipment.

Overview

The BS EN ISO 8536-12:2021 standard provides detailed specifications and guidelines for the design, performance, and testing of check valves used in infusion systems. These check valves are critical components that ensure the safe and effective delivery of fluids to patients, preventing backflow and maintaining the integrity of the infusion process.

Key Features

• Standard Number: BS EN ISO 8536-12:2021
• Pages: 18
• Release Date: February 22, 2021
• ISBN: 978 0 539 06873 3
• Status: Standard

Importance of Check Valves in Infusion Systems

Check valves play a pivotal role in infusion systems by allowing fluid to flow in one direction while preventing reverse flow. This functionality is crucial in maintaining the sterility and accuracy of fluid delivery, which is vital for patient safety and treatment efficacy. The BS EN ISO 8536-12:2021 standard ensures that these components meet stringent quality and performance criteria.

Benefits of Compliance

Adhering to the BS EN ISO 8536-12:2021 standard offers numerous benefits, including:

• Enhanced Safety: Ensures that check valves are designed to prevent contamination and backflow, safeguarding patient health.
• Regulatory Compliance: Aligns with international standards, facilitating market access and acceptance across different regions.
• Quality Assurance: Provides a framework for consistent manufacturing practices, leading to reliable and high-quality products.
• Innovation Support: Encourages the development of advanced infusion technologies by setting clear performance benchmarks.

Who Should Use This Standard?

The BS EN ISO 8536-12:2021 standard is indispensable for a wide range of stakeholders, including:

• Manufacturers: Companies involved in the production of medical infusion equipment can use this standard to ensure their products meet international quality and safety requirements.
• Healthcare Providers: Hospitals and clinics can rely on this standard to select infusion equipment that meets the highest safety and performance standards.
• Regulatory Bodies: Organizations responsible for the approval and oversight of medical devices can use this standard as a reference for compliance and quality assurance.

Detailed Content

Spanning 18 pages, the BS EN ISO 8536-12:2021 standard covers a comprehensive range of topics, including:

• Design Specifications: Detailed requirements for the physical and functional characteristics of check valves.
• Performance Testing: Guidelines for evaluating the performance and reliability of check valves under various conditions.
• Material Selection: Recommendations for materials that ensure durability and biocompatibility.
• Quality Control: Procedures for maintaining consistent quality throughout the manufacturing process.

Conclusion

The BS EN ISO 8536-12:2021 standard is a vital tool for ensuring the safety and effectiveness of infusion equipment used in medical settings. By providing clear guidelines and specifications, it helps manufacturers produce high-quality check valves that meet the needs of healthcare providers and patients alike. Embrace this standard to enhance the quality and reliability of your medical infusion products.

BS EN ISO 8536-12:2021

This standard BS EN ISO 8536-12:2021 Infusion equipment for medical use is classified in these ICS categories:

• 11.040.20 Transfusion, infusion and injection equipment

This document specifies requirements for check valves intended for single use and used with infusion equipment both with gravity-feed infusion and with pressure infusion apparatus.

The functional requirements in this document also apply to inline check valves.