BS EN ISO 9173-1:2016

Comprehensive Healthcare Technology Standard

Ensure your healthcare organization meets the highest standards of quality and safety with BS EN ISO 9173-1:2016. This essential standard, identical to ISO 9173-1:2016, provides detailed specifications and requirements for the design, manufacture, and use of healthcare technology products.

Comprehensive Guidance for Healthcare Professionals

BS EN ISO 9173-1:2016 covers a wide range of healthcare technology, including:• Medical devices• Diagnostic equipment• Therapeutic equipment• Assistive technologyThe standard offers comprehensive guidance on:• Design and development processes• Manufacturing and production controls• Packaging, storage, and distribution• Installation, maintenance, and servicing• Usability and human factors engineering

Ensure Compliance and Patient Safety

Compliance with BS EN ISO 9173-1:2016 is crucial for healthcare organizations to demonstrate their commitment to quality, safety, and regulatory requirements. Key benefits include:• Reduced risk of patient harm or adverse events• Improved product reliability and performance• Enhanced traceability and documentation• Streamlined regulatory approval processes• Increased customer confidence and satisfaction

Comprehensive Technical Specifications

BS EN ISO 9173-1:2016 provides detailed technical specifications and requirements, including:• Design input and output requirements• Risk management and mitigation strategies• Verification and validation procedures• Labeling, packaging, and sterilization• Post-production information and reportingThe standard also includes guidance on the application of relevant international standards, such as ISO 13485 for medical device quality management systems.

Ensure Quality and Safety with BS EN ISO 9173-1:2016

By implementing the requirements of BS EN ISO 9173-1:2016, healthcare organizations can demonstrate their commitment to quality, safety, and regulatory compliance. This comprehensive standard is an essential resource for healthcare professionals, manufacturers, and regulators, ensuring the delivery of safe and effective healthcare technology products.