Codes and Standards
Below is a library of all codes and standards used in the conduct of this project.
Safety and Accessibility Standards
International Organization for Standardization, ISO 12100:2010 – Safety of machinery – General principles for design – Risk assessment and risk reduction, Geneva, Switzerland, 2010.
Relevance: Provides a framework to identify, assess, and reduce risks during system design. Relevant to NAVI as it ensures safety in wearable device development for real-world use by visually impaired individuals.
International Organization for Standardization, ISO 14971:2019 – Medical devices – Application of risk management to medical devices, 3rd ed., Geneva, Switzerland, 2019. [Amendment A11:2021 available].
Relevance: Outlines processes for identifying and managing risks in systems that interact with human users. NAVI, while not a medical device, benefits from this rigorous risk analysis due to its assistive function.
U.S. Department of Justice, 2010 ADA Standards for Accessible Design, Washington, DC, 2010. [Online]. Available: https://www.ada.gov
Relevance: Ensures that NAVI aligns with federal guidelines for accessible technology, affirming that the product is designed inclusively for users with visual impairments.
Electrical and EMC Standards
International Electrotechnical Commission, IEC 60601-1:2005+AMD1:2012+AMD2:2020 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, 3rd ed. (Edition 3.2), Geneva, Switzerland, 2020.
Relevance: Establishes electrical safety and performance requirements for body-worn devices. Critical to NAVI’s design to avoid electrical hazards and ensure long-term safety.
ANSI/NEMA 250‑2020, Enclosures for Electrical Equipment (1000 Volts Maximum), NEMA, 2020.
Relevance: Specifies enclosure protection against environmental conditions (dust, water, etc.). Important for NAVI’s physical casing to ensure durability during outdoor use.
IPC-A-610H‑2020, Acceptability of Electronic Assemblies, IPC, 2020.
Relevance: Sets quality standards for soldering and electronic assembly. Ensures NAVI’s internal electronics meet reliability and manufacturing standards.
Human Factors and Usability Standards
International Organization for Standardization, ISO 9241-210:2019 – Ergonomics of human-system interaction – Part 210: Human-centred design for interactive systems, 2nd ed., Geneva, Switzerland, 2019.
Relevance: Guides the design of intuitive, comfortable, and user-friendly systems. Supports NAVI’s usability by focusing on tactile feedback, ergonomic placement, and ease of interaction for visually impaired users.
Development Process Standards
IEEE, IEEE Standard for Software Quality Assurance Plans, IEEE Std 730-2014, Jun. 2014.
Relevance: Provides structure for software testing, documentation, and reliability assurance. Ensures that NAVI’s embedded software functions correctly and is maintainable.
International Organization for Standardization, ISO/IEC 25010:2011 – Systems and software engineering – Systems and software Quality Requirements and Evaluation (SQuaRE) – System and software quality models, Geneva, Switzerland, 2011.
Relevance: Defines quality attributes such as performance, security, and usability. Helps evaluate and guide the software design and long-term behavior of NAVI’s control system.