Software item
The software system is made of software items, and the smallest ones are software units. The manufacturer decides how fine the breakdown is, and the software safety class can differ between items when they are properly separated.
any identifiable part of a computer program, i.e., source code, object code, control code, control data, or a collection of these items NOTE Three terms identify the software decomposition. The top level is the SOFTWARE SYSTEM. The lowest level that is not further decomposed is the SOFTWARE UNIT. All levels of composition, including the top and bottom levels, can be called SOFTWARE ITEMS. A SOFTWARE SYSTEM, then, is composed of one or more SOFTWARE ITEMS, and each SOFTWARE ITEM is composed of one or more SOFTWARE UNITS or decomposable SOFTWARE ITEMS. The responsibility is left to the MANUFACTURER to provide the granularity of the SOFTWARE ITEMS and SOFTWARE UNITS. NOTE 2 Based on ISO/IEC 90003:2004, 3.14 and ISO/IEC 12207:2008, 4.41
IEC 62304:2006+AMD1:2015, clause 3.25