Safety

Safety in ISO 14971 does not mean zero risk. A device is safe when its remaining risks have been judged acceptable against the criteria, taking the benefits into account.

freedom from unacceptable risk (3.18) [SOURCE: ISO/IEC Guide 63:2019, 3.10]

ISO 14971:2019, clause 3.26

freedom from unacceptable RISK [SOURCE: ISO/IEC Guide 63:2012, 2.16]

IEC 82304-1:2016, clause 3.19

freedom from unacceptable RISK [ISO 14971:2007, 2.24]

IEC 62304:2006+AMD1:2015, clause 3.21