YY/T 1406.1-2016
Medical device software.Part 1:Guidance on the application of ISO 14971 to medical device software (English Version)

Standard No.

YY/T 1406.1-2016

Language

Chinese, Available in English version

Release Date

2016

Published By

Professional Standard - Medicine

Latest

YY/T 1406.1-2016

Scope

This section provides that the requirements contained in YY/T 0316-2016 "Application of Medical Device Risk Management to Medical Devices" apply to the medical device software referred to in YY/T 0664-2008 "Medical Device Software Life Cycle Process" This section does not add or change the requirements of YY/T 0316-2016 or YY/T 0664-2008. This section is for use by risk management practitioners who need to implement risk management when the software is used as a medical device/system, and by software engineers who need to understand how to meet the risk management requirements set forth in YY/T 0316-2016. Regulators are aware that ISO 14971 is widely recognized around the world as an important standard for implementing medical device risk management. YY/T 0664-2008 normatively quotes the requirements in YY/T 0316-2016. These two standards provide the basis for this section. It should be noted that although YY/T 0316-2016 and this part focus on medical devices, this part can also be used to implement security risk management processes for all software in medical and healthcare environments, regardless of whether the software is classified as medical instruments. This part does not cover: 　——areas already covered by existing standards or planned standards, such as alarms, availability engineering, networks, etc.; 　——production or quality management system software; 　——software development tools. This section is not intended to serve as the basis for regulatory inspection or certification assessment activities. "Appropriate" in this section is used to indicate that among ten possibilities that meet the requirements, a particularly suitable one is recommended without mentioning or excluding other possibilities, or is used to indicate that a certain approach is better but not Necessary requirements. "Should" should not be understood as a requirement.

YY/T 1406.1-2016 Referenced Document

• YY/T 0316-2016 Medical devices.Application of risk management to medical devices
• YY/T 0664-2008 Medical devices software.Software life cycle processes

YY/T 1406.1-2016 history

• 2016 YY/T 1406.1-2016 Medical device software.Part 1:Guidance on the application of ISO 14971 to medical device software