Accompanying document

For standalone software the accompanying documents often carry most of the information a user gets: system requirements, installation, security settings and known limitations. IEC 82304-1 lists what they have to contain, and they are part of the health software product.

document accompanying HEALTH SOFTWARE containing information for the RESPONSIBLE ORGANIZATION or USER, particularly regarding SAFETY and/or SECURITY [SOURCE: IEC 60601-1:2005, 3.4, modified – Replace "ME EQUIPMENT, ME SYSTEM, equipment and accessory" by "HEALTH SOFTWARE" and replace "OPERATOR" by "USER" and added “and/or SECURITY”.]

IEC 82304-1:2016, clause 3.1