YY/T 0664-2020 Medical device software—Software life cycle processes

Scope

This standard applies to the development and maintenance of medical device software. Medical device software includes software that is itself a medical device or software that is embedded or a component of a final medical device.
Note 1: This standard can be used for the development and maintenance of software that is itself a medical device. However, additional development activities at the system level are required before this type of software can be put into use. This standard does not cover these system-level activities; for related requirements, please refer to IEC 82304-1[11].
This standard describes the processes intended for software that can be executed on a processor or through other software running on a processor (e.g., an interpreter).
This standard applies regardless of the type of persistent storage device used to store the software (e.g., hard disk, optical disc, permanent memory, or flash memory).
This standard applies regardless of the delivery method used to deliver the software [e.g., via network or email transmission, or physical transfer via optical disc, flash memory, or electrically erasable programmable read-only memory (EEPROM)]. The software delivery method itself is not considered medical device software.
This standard does not cover the validation and final release of medical devices, even if the medical device is entirely composed of software.
Note 2: If the medical device contains embedded software intended to be executed on a processor, the requirements of this standard apply to that software, including those related to software from unknown sources (see 8.1.2).
Note 3: Validation and other development activities at the system level are required before the software and medical device can be put into use. This standard does not cover these system-level activities; for related product standards, please refer to IEC 60601-1[6], IEC 82304-1[11], etc.

Development Information

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