Health Informatics — Application of clinical risk management to the manufacture of health software
ISO/TS 29321:2008 describes the risk management processes required to ensure patient safety in respect to the manufacture of health software products as defined in this document. It does not apply to software which is:
necessary for the proper application of a medical device or
which is an accessory to a medical device or
which is a medical device in its own right.
ISO/TS 29321:2008 applies to…
Health informatics — Guidance on the management of clinical risk relating to the deployment and use ...
ISO/TR 29322:2008 considers the risk management processes required to ensure patient safety in respect to the deployment and use of health software products either as a new system within a health organization or as changes to an existing system's environment.
It is addressed to those persons in health organizations who are responsible for ensuring the safety of health software in health…
