scope:

* Field of application

This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE when software is itself a MEDICAL DEVICE or when software is an embedded or integral part of the final MEDICAL DEVICE.

NOTE 1 This standard can be used in the development and maintenance of software that is itself a medical device. However, additional development activities are needed at the system level before this type of software can be placed into service. These system activities are not covered by this standard, but can be found in IEC 82304-1¹ [22].

This standard describes PROCESSES that are intended to be applied to software which executes on a processor or which is executed by other software (for example an interpreter) which executes on a processor.

This standard applies regardless of the persistent storage device(s) used to store the software (for example: hard disk, optical disk, permanent or flash memory).

This standard applies regardless of the method of delivery of the software (for example: transmission by network or email, optical disk, flash memory or EEPROM). The method of software delivery itself is not considered MEDICAL DEVICE SOFTWARE.

This standard does not cover validation and final release of the MEDICAL DEVICE, even when the MEDICAL DEVICE consists entirely of software.

NOTE 2 If a medical device incorporates embedded software intended to be executed on a processor, the requirements of this standard apply to the software, including the requirements concerning software of unknown provenance (see 8.1.2).

NOTE 3 Validation and other development activities are needed at the system level before the software and medical device can be placed into service. These system activities are not covered by this standard, but can be found in related product standards (e.g., IEC 60601-1, IEC 82304-1, etc.).

Compliance

NOTE 5 For compliance of LEGACY SOFTWARE see 4.4.

¹ In preparation.