BS EN ISO 17351:2014

## BS EN ISO 17351:2014 - Healthcare Technology Standard### OverviewBS EN ISO 17351:2014 is the essential standard for healthcare technology and medical equipment. Developed by the International Organization for Standardization (ISO), this standard provides comprehensive guidelines and requirements to ensure the safety, performance, and quality of a wide range of medical devices and related systems.### Key Features and Benefits- Covers a broad scope of healthcare technology, including: - Diagnostic and therapeutic medical equipment - Assistive products for persons with disability - Hospital and laboratory equipment - Implants and prostheses- Specifies design, manufacturing, and testing requirements to meet stringent safety and performance criteria- Ensures compliance with the latest regulations and best practices in the healthcare industry- Helps manufacturers, suppliers, and healthcare providers deliver high-quality, reliable, and safe medical products- Promotes patient safety and positive health outcomes through the use of standardized, quality-assured technologies### Technical SpecificationsBS EN ISO 17351:2014 is an identical adoption of the international standard ISO 17351:2013. The key technical requirements outlined in the standard include:- General safety and performance requirements- Risk management processes- Usability engineering- Sterilization and microbial contamination control- Electromagnetic compatibility (EMC)- Software life cycle processes- Clinical evaluation- Post-market surveillance### Compliance and Regulatory AlignmentConformance to BS EN ISO 17351:2014 is essential for healthcare organizations and medical device manufacturers to demonstrate compliance with various regulations and directives, including:- Medical Device Directive (MDD) 93/42/EEC- In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC- EU Medical Device Regulation (MDR) 2017/745- FDA Quality System Regulation (21 CFR Part 820)Adhering to this standard helps ensure that medical devices and equipment meet the necessary safety, performance, and quality requirements to be placed on the market and used in healthcare settings.### ConclusionBS EN ISO 17351:2014 is a critical standard for the healthcare technology industry, providing a comprehensive framework to design, manufacture, and maintain safe, reliable, and effective medical devices and equipment. By implementing the requirements outlined in this standard, organizations can demonstrate their commitment to patient safety, quality, and regulatory compliance, ultimately contributing to improved healthcare outcomes.