SM - WG 01- Software Working Group
AAMI Staff Contact
Rose Kodzwa RKodzwa@aami.org
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