BS EN 16128:2015

Comprehensive Healthcare Technology Standard

BS EN 16128:2015 is the essential British Standard for healthcare technology. Developed by industry experts, this standard provides comprehensive guidance on the design, manufacture, and use of healthcare technology products. Whether you're a medical device manufacturer, healthcare provider, or regulatory body, this standard is a must-have resource for ensuring compliance, quality, and safety in the healthcare sector.

Key Specifications

• Title: BS EN 16128:2015
• ISBN: 978 0 580 86487 2
• Price: £258.00
• Specifications: HEALTH CARE TECHNOLOGY|11|EN 16128:2015 Identical|2015-11-30|40|pdf|hardcopy

Ensure Compliance and Quality

BS EN 16128:2015 is a crucial standard for any organization involved in the healthcare technology industry. By adhering to the guidelines and requirements outlined in this standard, you can:

• Ensure your products meet the highest safety and quality standards
• Demonstrate compliance with relevant regulations and directives
• Improve the overall performance and reliability of your healthcare technology
• Reduce the risk of product failures or recalls
• Enhance patient safety and satisfaction

Comprehensive Guidance for Healthcare Technology

This British Standard covers a wide range of healthcare technology products, including:

• Medical devices
• Diagnostic equipment
• Assistive technologies
• Rehabilitation equipment
• Hospital and clinical furniture
• And more

The standard provides detailed guidance on the design, manufacturing, and testing of these products, ensuring they meet the necessary safety, performance, and regulatory requirements.

Design and Development

BS EN 16128:2015 outlines best practices for the design and development of healthcare technology products. This includes requirements for risk management, usability engineering, and the integration of human factors considerations.

Manufacturing and Production

The standard also covers the manufacturing and production processes for healthcare technology, with guidelines on quality control, process validation, and the management of manufacturing changes.

Testing and Evaluation

To ensure the safety and performance of healthcare technology products, BS EN 16128:2015 provides detailed requirements for testing and evaluation, including clinical trials, biocompatibility assessments, and post-market surveillance.

Ensure Compliance and Improve Patient Outcomes

By adhering to the guidelines and requirements outlined in BS EN 16128:2015, healthcare technology manufacturers and providers can demonstrate their commitment to quality, safety, and regulatory compliance. This, in turn, can help to improve patient outcomes, enhance the overall performance of healthcare technology, and build trust and confidence in the industry.

Invest in your organization's future and order your copy of BS EN 16128:2015 today.