Security

The definition covers both sides: keeping attackers out and keeping the data available to those who need it. IEC 82304-1 treats a breach of security as a potential source of harm, so security belongs in the risk analysis.

protection of information and data so that unauthorized persons or systems cannot read or modify them and authorized persons or systems are not denied access to them

IEC 82304-1:2016, clause 3.20

protection of information and data so that unauthorized persons or systems cannot read or modify them an authorized persons or systems are not denied access to them NOTE Based on ISO/IEC 12207: 2008, 4.39.

IEC 62304:2006+AMD1:2015, clause 3.22