Find My Committee
As we manage the migration from Committee Central to AAMI StMP, committees will shift to the new platform in several phases in order to keep committee work flowing smoothly.
The lists below will be updated for each phase so that you can verify the current platform for each of your committees.
SM - WG 01- Software Working Group
AAMI Staff Contact
standards@aami.org (a new staff person will be listed soon)
Description
The AAMI SM/WG 01- Software Working Group provides input into international standards developed by ISO/TC 210 – IEC/SC 62A JWG 3 - Medical device software, through the AAMI SM Committee and U.S. TAGs to ISO/TC 210 and IEC/62A.
Related Groups
Related Documents
- ANSI/AAMI/UL 2800-1:2019: Standard for Safety for Medical Device Interoperability
- ANSI/AAMI/IEC 80001-01: 2010, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
- AAMI/IEC TIR80002-1: 2009, Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
- AAMI/IEC TR 80001-2-1: 2012, Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples
- AAMI/IEC TR 80001-2-2: 2012, Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the communication of medical device security needs, risks and controls
- AAMI/IEC TR 80001-2-3: 2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
- AAMI/IEC TR 80001-2-4: 2012, Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for Healthcare Delivery Organizations
- AAMI/IEC TR 80001-2-5: 2014, Application of risk management for IT-networks incorporating medical devices - Part 2-5: Guidance on distributed alarm systems
- AAMI/ISO TIR80002-2: 2017, Medical device software - Part 2: Validation of software for regulated processes
- ANSI/AAMI/IEC 62304:2006 & A1:2016 Medical device software - Software life cycle processes
- ANSI/AAMI/IEC 62304: 2006 & A1:2016 (Redline) Medical device software—Software life cycle processes