ISO 15137:2005

ISO 15137:2005 - Healthcare Technology Standard

ISO 15137:2005 is a critical standard for healthcare organizations, medical device manufacturers, and professionals working in the field of healthcare technology. This comprehensive standard provides guidelines and requirements for the design, development, and implementation of healthcare technology systems, ensuring patient safety, quality of care, and regulatory compliance.

Key Features and Benefits:

• Comprehensive Coverage: ISO 15137:2005 covers a wide range of healthcare technology, including medical devices, information systems, and supporting infrastructure. It addresses the entire lifecycle of these technologies, from design and development to deployment and maintenance.
• Patient Safety: The standard emphasizes the importance of patient safety, with detailed requirements for risk management, usability, and cybersecurity to protect patients from harm.
• Quality of Care: By ensuring the reliability, interoperability, and effectiveness of healthcare technology, ISO 15137:2005 helps healthcare providers deliver the highest quality of care to their patients.
• Regulatory Compliance: Adherence to this standard demonstrates compliance with various healthcare regulations and guidelines, such as the EU Medical Device Regulation (MDR) and the US Food and Drug Administration (FDA) requirements.
• Improved Efficiency: The standard provides a framework for streamlining healthcare technology processes, reducing costs, and increasing operational efficiency.

Technical Specifications:

• Standard: ISO 15137:2005
• Title: Health care technology - Clinical information model - Characteristics
• Publication Date: 2005-07-15
• Pages: 12
• Format: PDF and hardcopy
• Price: £70.00

ISO 15137:2005 is an essential resource for healthcare organizations, medical device manufacturers, and professionals working in the field of healthcare technology. By implementing the guidelines and requirements outlined in this standard, organizations can ensure the safety, quality, and compliance of their healthcare technology systems, ultimately improving patient outcomes and the overall delivery of healthcare services.