FDA Final Guidance - Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM077295.pdf
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM077295.pdf