ISO STANDARDS

1. Device-Specific Standards

• ISO 19408:2023

This Technical Specification defines terms commonly used for measuring feet and lasts and for determining the size of footwear. It covers the specifications for shoe assembly such as dimensions which include length, width and heel height, shoe size marking, material specifications and design considerations to enhance comfort and functionality.

The device, being footwear, will comply with this ISO standard in the size and dimensions of the attachment. The device will be of the required size to ensure comfort as well as its functionality when in use.

• ISO 24263:2020

This standard specifies the methods for determining the attachment strengths of footwear straps and trims. It provides a standardized method for evaluating the strength of attachments, ensuring components like straps and trims remain securely fastened during use. It focuses on attachment points by evaluating straps joined to the sole, hooks and eyelets, outlines procedures for testing the strength and durability of these attachments under specified conditions as well as establishing minimum performance requirements to ensure that attachments can withstand typical stresses encountered during use. 

Through testing of the straps, the device will be able to withstand the forces and stresses encountered during the rehabilitation process. It will comply with this ISO requirement.

• ISO 16177:2012

It focuses on the resistance to crack initiation and growth using a belt flex method. It evaluates how well footwear materials withstand repeated flexing, provides a standardized method to assess material performance and help ensure that footwear meets safety requirements.

The device will comply with this requirement and ensure that safety requirements highlighted are met.

• ISO 13287

This tests the slip resistance of various types of footwear materials. Key tests include coefficient of friction, dynamic slip resistance, surface conditions and test modes which are forward heel slip at angled contact, backward slip on the forepart and forward flat slip.

The tests will subject the device to and show its  behavior in different surface conditions. Compliance with this ISO standard will ensure that the attachment does not cause harm by slipping.

2.General Standards

• ISO 13485:2016

This outlines the requirements for a Quality Management System(QMS) specific to medical devices. It applies throughout the entire lifecycle of the medical device, from design to post-market activities. It emphasizes a risk-based approach to product development and quality management process. It also specifies the need for comprehensive documentation, including quality manuals and procedures.

• ISO 14971:2012

This provides a framework for risk management specific to medical devices. It includes a risk management process, terminology and definitions (terms such as risk, hazard and safety), lifecycle coverage (applies to all phases of a medical device’s lifecycle from design to post-market activities), residual risk evaluation and integration with quality management systems.

The shoe spring attachment will be subject to this standard which includes identifying hazards associated with the device, estimating the potential probability of the risks occurring, developing and implementing safeguards if any and regular reviews and monitoring to assess the effectiveness of safeguards implemented.

• ISO 14155

This outlines good clinical practices for the design, conduct, recording and reporting of clinical investigations involving medical devices. Key aspects include ethical consideration where it emphasizes on the protection of human subjects’ rights, safety and well-being, details the requirements for the clinical investigation plan, defines the roles and responsibilities of sponsors and principal investigators in managing clinical trials, incorporates risk management principles throughout the investigation process linking with ISO 14971 and stipulates thorough documentation practices for data integrity and compliances.

The device will be subject to this standard in ensuring the safety and well-ness of subjects used in the clinical trials.

• IEC 62366-1

This focuses on the application of usability engineering to medical devices. It enhances the safety and effectiveness of medical devices by addressing user interaction and potential errors. Key elements include a structured process for analyzing, specifying, developing and evaluating the usability of medical devices, risk mitigation and documentation requirements.

• ISO 15223-1:2016

This specifies requirements for symbols that can be used on medical devices, packaging or associated documentations to ensure clear communication.