BS EN ISO 8536-2:2010 - Essential Standard for Infusion Equipment

The BS EN ISO 8536-2:2010 standard is a crucial reference in the field of health care technology, specifically designed to govern the requirements for infusion equipment for medical use. This British Standard, identified by ISBN 978 0 580 71529 7, was published on April 30, 2010, and aligns directly with the international ISO standard ISO 8536-2:2001/Cor 1:2003, ensuring a recognized standard in the UK and beyond.

Purpose and Scope

The primary aim of BS EN ISO 8536-2:2010 is to safeguard the quality and safety of infusion devices used in healthcare settings. It outlines the essential requirements and testing procedures to ensure that infusion systems provide precise and safe administration of fluids, including medications and nutrients. This standard is pivotal for manufacturers, healthcare professionals, and regulatory bodies involved in the design, testing, and use of infusion equipment.

Key Features

• Comprehensive Guidelines: The standard provides detailed guidelines on design, construction, and performance of infusion devices, ensuring they meet safety and efficacy criteria.
• Quality Assurance: Emphasizes the need for robust quality management systems throughout the lifecycle of medical devices, from manufacture to clinical use.
• Testing Protocols: Implements specific testing protocols necessary for compliance, addressing both functional reliability and user safety.
• Interoperability: Promotes compatibility with other medical devices and systems, fostering an integrated approach to patient care.
• Clinical Relevance: Ensures equipment quality aligns with best clinical practices, ultimately enhancing patient outcomes.

Who Should Use This Standard?

This standard is indispensable for a variety of stakeholders in the healthcare sector, including:

• Manufacturers of infusion devices seeking to comply with international safety standards.
• Healthcare professionals involved in the selection and administration of infusion therapies.
• Quality assurance teams and regulatory bodies responsible for oversight of medical devices.
• Educational institutions engaged in training future healthcare providers and engineers in safe infusion practices.

Conclusion

Investing in the BS EN ISO 8536-2:2010 standard not only helps ensure compliance with recognized international standards but also enhances patient safety, efficacy of treatments, and operational excellence within healthcare environments. With a price of just £158.00, this comprehensive document is a vital resource for all entities involved with infusion therapy in medicine. Ensure your practice meets the highest standards by incorporating this crucial guideline today.