BS EN 14675:2015

Comprehensive Healthcare Technology Standard

BS EN 14675:2015 is the essential standard for healthcare technology professionals. This comprehensive specification outlines the requirements and test methods for the design, manufacture, and performance of medical devices and equipment. Ensure your products meet the highest standards of quality, safety, and compliance with this authoritative British Standard.

Key Features and Benefits:

- Detailed technical specifications for a wide range of healthcare technologies- Ensures compliance with the latest European regulations and directives- Supports the development of safe, reliable, and effective medical devices- Promotes best practices in design, manufacturing, and testing- Helps organizations mitigate risks and avoid costly non-compliance issues

Comprehensive Technical Guidance

BS EN 14675:2015 provides in-depth technical guidance across 38 pages, covering the following key areas:• General requirements for medical devices• Design and manufacturing considerations• Performance testing and evaluation• Biocompatibility and sterilization• Electrical safety and electromagnetic compatibility• Usability and human factors engineering• Risk management and quality assuranceThe standard is structured to align with the essential requirements of the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC), ensuring your products meet the necessary regulatory compliance.

Ensure Compliance and Quality

Implementing the specifications outlined in BS EN 14675:2015 is crucial for healthcare organizations and medical device manufacturers. By adhering to this standard, you can:• Demonstrate compliance with the latest European regulations• Enhance the safety, reliability, and performance of your medical devices• Reduce the risk of product recalls, liability issues, and regulatory sanctions• Improve customer confidence and satisfaction in your healthcare technologies• Streamline the product development and approval process

Trusted by Healthcare Professionals

BS EN 14675:2015 is an essential reference for a wide range of healthcare professionals, including:• Medical device manufacturers• Research and development teams• Quality assurance and regulatory affairs specialists• Healthcare procurement and supply chain managers• Clinical engineers and biomedical techniciansEnsure your medical devices and equipment meet the highest standards of quality, safety, and compliance. Invest in BS EN 14675:2015 and unlock the benefits of this authoritative healthcare technology standard.