AAMI TIR32:2004
Medical device software risk management

Standard No.
AAMI TIR32:2004
Release Date
2004
Published By
Association for the Advancement of Medical Instrumentation  US  /  AAMI
Latest
AAMI TIR32:2004
 
Scope
Effective Software Risk Management is a significant part of the overall risk management process for medical devices containing software. This Technical Information Report (TIR) provides information useful to performing effective software risk management.

AAMI TIR32:2004 history

Standard and Specification

AAMI TIR32:2004(R2016 Medical device software risk management AAMI TIR32-2004(2016 Medical device software risk management AAMI/IEC TIR80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software DS/IEC/TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software GOST R 59766-2021 Software as a medical device. Possible framework for risk categorization and corresponding considerations AAMI/IEC 62304:2006 Medical device software - Software life cycle processes GSO IEC/TR 80002-1:2015 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software GOST ISO 14971-2021 Medical devices. Application of risk management to medical devices AS ISO 14971:2020 Medical devices — Application of risk management to medical devices


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