BS ISO 20417:2021 pdf download.Medical devices — Information to be supplied by the manufacturer.
6.6.3 Additional requirements for the instructions for use for a lay user
a) Where the patient is an intended user, the instructions for use shall identify, as applicable:
1) that the patient is an intended user; or
2) that the medical device is intended for self-testing..
NOTE For a medical device where the intended use includes the patient partially or fully operating the medical device, the patient becomes a user.
b) Where the intended user is a lay user, the instructions for use shall identify, where applicable:
1) clearly and concisely the circumstances when the user should consult with a healthcare
professional;
2) a warning against servicing and maintenance while the medical device is in use;
3) which functions the lay user can safely use;
4) which functions the lay user cannot safely use; and
5) which maintenance the lay user can perform (e.g., changing batteries).
NOTE For a medical device where the lay user is allowed to perform restricted maintenance, the lay user becomes service personnel.
c) Where the intended user is a lay user, the instructions for use shall be available in a format
appropriate and accessible to the lay user.
d) Where the intended user is a lay user, the instructions for use shall allow the intended lay user:
1) to understand and apply, in order to correctly interpret, the result provided by the
medical device; or
i) Where applicable, the instructions for use shall include pictorial representations of all
possible results (including when a medical device has failed to provide a valid result) for
medical devices that give a visual readout.
2) to confirm that the medical device is operating or has operated as intended.
e) Where the intended user is a lay user and the intended use environment includes home use, the instructions for use may omit some of the recommended elements of 6.6.2, provided this does not affect safety or performance.
1) The justification for any omission shall be evaluated according to ISO 14971:2019.
Check conformance by inspection of the instructions for use.
6.6.4 Requirements for technical description
a) The technical description shall include all of the following:
1) if separate from the instructions for use:
i) the general information of 6.6.1;
ii) the information in 6.6.2 a) 2);
iii) the information in 6.6.2 a) 3); and
iv) the information in 6.6.2 a) 4);
2) information regarding any:
i) acceptance and performance testing; and
ii) recurrent testing and maintenance, including details of the means, methods and
recommended frequency;
3) all critical characteristics of the medical device, as well as range and precision of all the
measured or displayed values or performances or an indication where they can be found; and
4) a unique version identifier such as a date of issue or revision number.BS ISO 20417 pdf download.