BS EN ISO 22675:2016

Comprehensive Healthcare Technology Standard

BS EN ISO 22675:2016 is a critical standard for the healthcare industry, providing detailed specifications and requirements for testing lower-limb prostheses and orthoses. This standard, which is identical to ISO 22675:2016, ensures the safety, performance, and reliability of these essential medical devices.

Key Features and Benefits:

- Comprehensive testing protocols for lower-limb prostheses and orthoses- Ensures the safety and durability of these critical healthcare products- Supports compliance with relevant regulations and industry best practices- Applicable to a wide range of lower-limb devices, including prosthetic feet, ankles, and knees- Helps manufacturers and healthcare providers deliver high-quality, reliable products to patients

Detailed Technical Specifications

BS EN ISO 22675:2016 covers a wide range of technical requirements and test methods for lower-limb prostheses and orthoses, including:- Static, dynamic, and fatigue testing- Impact and overload testing- Determination of structural integrity and resistance to wear- Evaluation of functional characteristics, such as range of motion and energy returnThe standard also provides guidance on test specimen preparation, test equipment, and reporting requirements, ensuring consistent and reliable results across the industry.

Ensuring Compliance and Patient Safety

Compliance with BS EN ISO 22675:2016 is essential for healthcare providers and manufacturers of lower-limb prostheses and orthoses. By adhering to the standards set forth in this document, organizations can:- Demonstrate the safety and performance of their products to regulatory bodies and customers- Reduce the risk of product failures or malfunctions that could harm patients- Improve the overall quality and reliability of lower-limb medical devices- Stay up-to-date with the latest industry best practices and technological advancements

Accessing the Standard

BS EN ISO 22675:2016 is available in both digital and hardcopy formats. You can download the PDF version or order a printed copy through our website. Our team of experts is also available to provide guidance and support on implementing this standard within your organization.