prCEN ISO/TS 29321

Health Informatics - Application of clinical risk management to the manufacture of health software (ISO/TS 29321:2008)

Scope

This TS will lay down requirements for risk management in the manufacture of health software products. In this context a manufacturer is "any natural or legal person with responsibility for the design, manufacture, packaging, or labelling of a health software product, assembling a system, or adapting a health software product before it is placed on the market and/or put into service, regardless of whether these operations are carried out by that person or on that person's behalf by a third party (ISO14971 modified)". A health software product is "any software for use in the health sector for health-related purposes but excluding 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.
The requirements will, as far as practicable, be in line for those applicable to medical devices such as in ISO 14971.