ISO Standards for our Foldable Crutches 
Designing for ISO testing compliance
1. ISO 13485:2016 – Medical Devices: Quality Management Systems 
This standard specifies the necessary criteria for a quality management system (QMS) in the design and production of medical devices. It applies to organizations involved in the design, development, manufacturing, and provision of medical devices or related services. 
Design Controls: ISO 13485 mandates rigorous design control procedures, ensuring that the crutches fulfill specified requirements regarding safety, performance, and user-friendliness. The design of our crutches must undergo formal validation and verification testing to guarantee compliance with safety standards. 
Risk Management: The standard highlights the importance of risk management throughout the entire product lifecycle. A comprehensive risk assessment must be performed, taking into account possible risks linked to our crutch use, such as instability, sharp surfaces, or failures in
We will develop a comprehensive testing plan to ensure the crutches pass all ISO-required safety tests (e.g., static and dynamic load testing, impact resistance, and corrosion resistance). 
Document and Record Control: our processes for design and testing will be thoroughly documented, with complete traceability from design inputs to final production and testing. This includes maintaining records of testing methods, materials utilized, and outcomes of all compliance evaluations. 
Post-Market Surveillance: ISO 13485 obliges manufacturers to monitor the product's performance after it has been released in the market, gathering information on its safety and effectiveness in real-life settings. We shall utilize user feedback to enhance future designs.
2. ISO 7176 – Wheelchairs and Related Equipment 
This set of standards outlines the safety and performance criteria for mobility devices, such as wheelchairs, crutches, and walking aids. It encompasses requirements for durability, performance evaluation, and safety features. 
ISO 7176-1 (General Requirements): This section details the basic requirements for the design and construction of mobility aids. For foldable crutches, it guarantees that the crutches are stable, resilient, and safe for users. The crutches must be subjected to tests that ensure they can support a specified load without failure. 
ISO 7176-3 (Resistance to Static Load): This portion emphasizes evaluating the capability of mobility devices to handle static loads, such as the user's body weight. Our foldable crutches are required to support a designated weight without bending, breaking, or compromising the locking mechanism. 
ISO 7176-4 (Wheelchair Testing for Safety): While concentrated on wheelchairs, the testing principles for impact resistance, stability, and tipping directly relate to crutches. Our foldable crutches should undergo tests to confirm their ability to endure everyday impacts (e.g., being dropped or bumped) without failing. 
ISO 7176-8 (Durability Testing): This section of the standard delineates the requirements for assessing the crutches' durability through repeated usage. Our crutches must successfully complete durability assessments simulating months or years of typical use, including the cycles of folding and unfolding, weight-bearing, and wear on gripping handles and other moving components.
3. ISO 14971:2019 – Risk Management for Medical Devices
ISO 14971 provides a framework for managing risks associated with medical devices, focusing on risk analysis, evaluation, control, and monitoring throughout the device lifecycle.
the folding mechanisms.
  Hazard Analysis:

• We aim to identify potential risks, such as crutch collapse, failure to lock securely, or discomfort during use.
• We will include hazard mitigations such as reinforcement of locking mechanisms, material selection to prevent breakage, and ergonomic improvements.

  Risk Mitigation:

• We aim to design the crutches with redundant safety features (e.g., double-locking mechanisms).
• We will select high-strength materials like aluminum alloys or reinforced polymers to ensure durability and prevent failure.

Post-Market Risk Surveillance: Once our crutches are launched into the market, continuous oversight is essential to observe any negative incidents associated with the product's performance. Should users encounter issues, like crutches collapsing under weight, we are obligated to implement corrective measures.