Accompanying documentation

ISO 14971 counts information for safety in the accompanying documentation as a risk control measure, the last option after inherently safe design and protective measures. It does not have to be printed: videos, sounds and on-screen help count too.

materials accompanying a medical device (3.10) and containing information for the user or those accountable for the installation, use, maintenance, decommissioning and disposal of the medical device (3.10), particularly regarding safe use Note 1 to entry: The accompanying documentation can consist of the instructions for use, technical description, installation manual, quick reference guide, etc. Note 2 to entry: Accompanying documentation is not necessarily a written or printed document but could involve auditory, visual, or tactile materials and multiple media types.

ISO 14971:2019, clause 3.1

materials accompanying a MEDICAL DEVICE and containing information for the USER or those accountable for the installation, use, maintenance, decommissioning and disposal of the MEDICAL DEVICE, particularly regarding safe use Note 1 to entry: The ACCOMPANYING DOCUMENTATION can consist of the instructions for use, technical description, installation manual, quick reference guide, etc. Note 2 to entry: ACCOMPANYING DOCUMENTATION is not necessarily a written or printed document but could involve auditory, visual, or tactile materials and multiple media types. Note 3 to entry: MEDICAL DEVICES that can be used safely without instructions for use are exempted from having instructions for use by some authorities with jurisdiction. [SOURCE: ISO 14971:2019, 3.1, modified – Note 3 to entry has been added.]

IEC 62366-1:2015+AMD1:2020, clause 3.2