ANALYSIS TYPE / 02

Item Definition — Establishing the Foundation for HARA and All Downstream Safety Planning

System Boundary · Function Allocation · Interface Documentation

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Overview

Item Definition

Item definition establishes the system boundary, operational design domain, functions, and interfaces of the safety-relevant item. It is the foundational input for HARA and all subsequent safety planning — and must be complete before risk assessment can begin. A rigorous item definition prevents scope creep during HARA, ensures all safety-relevant functions are captured, and provides the documented interface assumptions that downstream system and software safety activities depend on.

Industries Served

AutomotiveAerospaceIndustrial EquipmentRailMedical Devices

Standards

ISO 26262 Part 3IEC 61508 Part 2

Key Aspects

What Item Definition Involves

01

Boundary Definition

Establishing what is inside and outside the item — including hardware, software, sensors, actuators, and human interaction points.

02

Function Identification

Listing all functions the item performs, including primary safety-relevant functions and secondary operational functions.

03

Interface Documentation

Documenting all electrical, mechanical, and logical interfaces between the item and its environment, including assumed system-level constraints.

04

Operational Design Domain

Defining the environmental conditions, operational modes, and use cases within which the item is required to function safely.

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