21/30428107 DC - BS 34971/AAMI CR 34971. Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning

21/30428107 DC

BS 34971/AAMI CR 34971. Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning

Status : Draft for public comment, Current   Published : June 2021

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Standard Number21/30428107 DC
TitleBS 34971/AAMI CR 34971. Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
StatusDraft for public comment, Current
Publication Date04 June 2021
Normative References(Required to achieve compliance to this standard)ISO 14971:2019
Informative References(Provided for Information)ISO/IEC 22989, ISO/IEC AWI TR 24027, ISO/IEC 29119-11, IEC 80001-1:2010, IEC TR 80002-1:2009, ISO 14971:2019, ISO/TR 24971:2020, ISO/IEC TR 24028:2020, IEC TR 60601-4-1:2017, AAMI TIR66:2017/(R)2020, ISO/IEC 2382:2015
Draft Expiry Date08 August 2021
DescriptorsLearning machines, Artificial intelligence, Diagnosis (medical), Clinical investigation instruments, Hazards, Risk assessment, Management, Medical instruments, Medical equipment, Risk analysis, Safety measures
ICS11.040.01
35.020
CommitteeCH/210/4
PublisherBSI
FormatA4
DeliveryYes
Pages24
File Size996 KB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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