BS EN ISO 11143:2008

BS EN ISO 11143:2008 - Health Care Technology Standards

The BS EN ISO 11143:2008 standard outlines essential specifications and guidelines for the quality and performance assessment of healthcare technologies, specifically in the context of non-invasive and minimally invasive medical devices. As a crucial framework in the modern health care environment, this standard is vital for ensuring optimal safety and efficacy in medical practices across the European Union.

This standard, published on September 30, 2008, serves as an identical adoption of the ISO 11143:2008, maintaining consistency and coherence in healthcare technology specifications worldwide. By adhering to these standards, healthcare providers can be confident in the effectiveness and reliability of their medical devices, minimizing risks associated with patient care.

Key Features and Benefits

• Comprehensive Guidelines: The standard provides detailed criteria for evaluating healthcare technologies, ensuring that all devices meet established safety and performance benchmarks.
• Improved Patient Safety: By implementing BS EN ISO 11143:2008, healthcare facilities can enhance patient safety through the use of rigorously tested and certified medical equipment.
• Regulatory Compliance: Compliance with this standard contributes to alignment with EU regulations, aiding healthcare organizations in navigating complex legal landscapes.
• Enhanced Device Performance: The standard emphasizes continuous improvement and innovation, encouraging the development of advanced medical technologies that meet users' evolving needs.

Specifications

The ISBN for BS EN ISO 11143:2008 is 978 0 580 58161 8 and is available in both PDF and hardcopy formats. The standard focuses on various aspects of health care technology, providing insights into performance testing and evaluation methodologies. Priced at £258.00, it represents a valuable investment in the quality assurance of healthcare services.

Implementation and Usage

Healthcare providers, device manufacturers, and regulatory bodies will find this standard instrumental in fostering a culture of safety and performance excellence. It is recommended that organizations incorporate BS EN ISO 11143:2008 into their quality management systems and training programs to ensure all personnel are proficient in standard compliance.

In summary, BS EN ISO 11143:2008 stands as a pivotal resource in the realm of healthcare technology, driving the conversation towards enhanced patient care, device reliability, and regulatory adherence. By leveraging this standard, stakeholders in the healthcare industry can not only meet but exceed existing benchmarks for medical devices.