Health Care Technology
Official British Standard
BS EN 60601-2-24:2015
Comprehensive healthcare technology standard BS EN 60601-2-24:2015. Ensure medical device safety and compliance with this essential British Standard.
Comprehensive Healthcare Technology Standard
BS EN 60601-2-24:2015 is a critical British Standard that specifies the safety and essential performance requirements for infusion pumps and related medical devices. This standard is an essential reference for manufacturers, healthcare providers, and regulatory bodies to ensure the safe and effective use of infusion pumps in medical settings.Ensure Compliance and Patient Safety
Compliance with BS EN 60601-2-24:2015 is crucial for medical device manufacturers and healthcare organizations to demonstrate their commitment to patient safety and regulatory adherence. This standard aligns with the following international standards:- EN 61925:2006 (Identical)- IEC 60115-2-10 Ed.2.0 (Identical)- IEC 60601-2-24:2012 (Identical)- EN 60601-2-24:2015 (Identical)By adhering to the requirements outlined in this standard, medical device manufacturers can:- Minimize the risk of patient harm from infusion pump malfunctions or errors- Demonstrate compliance with the essential safety and performance requirements- Streamline the regulatory approval process for their medical devices- Enhance the overall quality and reliability of their infusion pump productsComprehensive Technical Specifications
BS EN 60601-2-24:2015 covers a wide range of technical specifications and requirements for infusion pumps, including:- General requirements for basic safety and essential performance- Specific requirements for the safety of infusion pumps and related devices- Electromagnetic compatibility (EMC) testing and requirements- Usability engineering and human factors considerations- Alarm systems and indicators- Mechanical and electrical safety- Software and cybersecurity requirementsBy thoroughly understanding and implementing the technical specifications outlined in this standard, medical device manufacturers can:- Ensure the safe and reliable operation of their infusion pumps- Mitigate the risk of electromagnetic interference and other environmental factors- Enhance the user-friendliness and intuitiveness of their devices- Protect patient data and prevent cybersecurity breachesComprehensive Guidance for Healthcare Providers
In addition to its importance for medical device manufacturers, BS EN 60601-2-24:2015 also provides valuable guidance for healthcare providers and organizations. This standard can help healthcare professionals:- Understand the safety and performance requirements for infusion pumps- Evaluate and select appropriate infusion pump devices for their clinical settings- Ensure the proper installation, maintenance, and use of infusion pumps- Develop training and protocols for the safe and effective use of infusion pumps- Comply with regulatory requirements and industry best practicesBy aligning their infusion pump practices with the requirements of BS EN 60601-2-24:2015, healthcare providers can enhance patient safety, improve clinical outcomes, and demonstrate their commitment to delivering high-quality, evidence-based care.Technical Information
Health Care Technology
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Specification Details
- Medical electrical equipment - Particular requirements for the basic safety and essential performance of infusion pumps and controllers
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