
IEC 62304 Software Safety Classification Explained
IEC 62304 software safety classification explained: how Class A, B and C are assigned, what each class requires, and what Edition 2 changes.
The core responsible AI principles from the OECD and NIST, what each means in practice, and how to turn them into policies, reviews, and controls.

Responsible AI principles are the commitments an organization makes about how its AI systems should behave: fairly, transparently, safely, securely, and with clear accountability. Most organizations now have some version of them. The hard part is turning a list of values into practices that change how systems are designed, tested, and run. This guide sets out the principles most frameworks share, what each means in day-to-day work, and how to put them into practice.
Two public frameworks shape most corporate principles.
In the EU, the AI Act turns many of these ideas into legal obligations, with requirements that scale by risk level.
The OECD's values-based principles are inclusive growth and well-being; human rights and democratic values, including fairness and privacy; transparency and explainability; robustness, security and safety; and accountability. NIST lists the characteristics of trustworthy AI as valid and reliable, safe, secure and resilient, accountable and transparent, explainable and interpretable, privacy-enhanced, and fair with harmful bias managed. Combined, they give a practical set:
| Principle | What it means in practice |
|---|---|
| Valid and reliable | The system is tested on realistic data and keeps performing as intended after launch. |
| Fairness | Harmful bias is identified, measured, and reduced, and results are checked across relevant groups. |
| Transparency and explainability | People know when they interact with AI, and decisions can be explained at a level suited to the audience. |
| Safety, security, and robustness | The system resists misuse and attacks and fails in a controlled way. |
| Privacy | Personal data is minimized, protected, and used on a lawful basis. |
| Accountability | Named people own each system and its outcomes, with a route for redress when things go wrong. |
NIST stresses that these characteristics involve tradeoffs. Its framework gives examples such as interpretability versus privacy, and accuracy versus interpretability, and notes that trustworthiness is only as strong as its weakest characteristic. A principle that says "be fair" does not tell a team which metric to use or what threshold to accept. That is why principles need supporting processes.
Name an executive sponsor and a cross-functional group covering product, engineering, legal, privacy, and security. Give every AI system a named business owner.
List every AI system in use or development, including vendor tools. Classify each by impact, and in the EU, by AI Act risk level. Higher-risk systems get more review.
Tell people when they are interacting with an AI system, explain what it does and its limits, and offer a route to a human where decisions matter.
In the EU, AI literacy obligations have applied since February 2, 2025. Beyond compliance, teams cannot apply principles they do not understand.
A governance framework ties these steps together. Our guide to building an AI governance framework covers the structure, and our healthcare AI governance guide covers sector-specific rules.
Responsible AI principles matter only when they change decisions. Start from shared frameworks such as the OECD AI Principles and the NIST AI RMF, then turn each principle into an owner, a check in the lifecycle, and a metric you track. For help designing responsible AI practices that fit how your teams build, explore Ekipa's AI delivery framework or book a consultation.
Most frameworks cover fairness, transparency and explainability, safety and security, privacy, reliability, and accountability. The OECD AI Principles and the NIST AI Risk Management Framework are the most widely used references.
Responsible AI principles state what good looks like. AI governance is the set of roles, processes, and controls that make sure systems meet those principles in practice.
Principles themselves are voluntary, but laws such as the EU AI Act turn many of them into obligations, including transparency, human oversight, and risk management for high-risk systems.
Choose metrics that fit the use case, such as error rates or outcomes across relevant groups, and set thresholds before testing. NIST notes that fairness definitions vary by context, so document the choice and the reasoning.
An executive sponsor with a cross-functional group sets policy, while each AI system has a named business owner accountable for its outcomes.

IEC 62304 software safety classification explained: how Class A, B and C are assigned, what each class requires, and what Edition 2 changes.

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