What is ISO 81001-1?
It is the principles and concepts standard for health software and health IT systems. It sets the shared terms and concepts for safety, effectiveness and security across the life cycle, from concept to decommissioning, and it describes eight foundational elements in Clause 5 that support the core themes in Clause 4.
Where this comes from
It is the principles and concepts standard for health software and health IT systems. It sets the shared terms and concepts for safety, effectiveness and security across the life cycle, from concept to decommissioning, and it describes eight foundational elements in Clause 5 that support the core themes in Clause 4.
The answer rests on the public record. Where the draft text is not public, the answer says so and does not state a requirement as the draft's own. The sources.