Medical Device Software

Medical Device Software, Total:33 items.

The international standard classification for "Medical Device Software" includes: Medical equipment in general .

The Chinese standard classification for "Medical Device Software" includes: Medical apparatus and devices in general .

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Professional Standard - Medicine

• YY/T 1406.1-2016 Medical device software—Part 1:Guidance on the application of ISO 14971 to medical device software
• YY/T 1406.1-2016/IEC/TR 80002-1 Medical Device Software Part 1: Guidelines for YY/T 0316 Applied to Medical Device Software
• YY/T 0664-2020 Medical device software—Software life cycle processes
• YY/T 0664-2008 Medical device software - Software life cycle processes

German Institute for Standardization

• DIN EN 62304:2016-10*VDE 0750-101:2016-10 Medical device software

British Standards Institution (BSI)

• BS PD IEC/TR 80002-1:2009 Medical device software-Guidance on the application of ISO 14971 to medical device software
• BS PD IEC/TR 80002-3:2014 Medical device software. Process reference model of medical device software life cycle processes (IEC 62304)
• BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
• BS EN 62304:2006 Medical device software - Software life-cycle processes

Gosstandart of Russia

• GOST R 55544-2013 Medical devices software. Part 1. Guidance on the application of ISO 14971 medical devices software
• GOST R IEC 62304-2013 Medical device software. Software life cycle processes

Danish Standards Foundation

• DS/IEC/TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

International Electrotechnical Commission (IEC)

• IEC TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
• IEC TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
• IEC/TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
• IEC/TR 80002-3:2014 Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
• IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
• IEC TR 80002-3:2014 Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
• IEC TR 80002-3:2014 Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
• IEC 62304:2006/AMD1:2015 Medical device software - Software life cycle processes
• IEC 62304:2015 Medical device software - Software life cycle processes

American National Standards Institute （ANSI)

• AAMI TIR32:2004(R2016) Medical device software risk management
• AAMI TIR32:2004 Medical device software risk management
• ANSI/AAMI/IEC TIR80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
• AAMI TIR32-2004(2016) Medical device software risk management

Association of German Mechanical Engineers

• VDI-EE 5702 BLATT 3-2024 Medizinprodukte-Software - Medical SPICE - Empfehlungen fuer die Softwareentwicklung
• VDI 5702 BLATT 1-2017 Medizinprodukte-Software - Medical SPICE Prozessassessmentmodell

Bureau of Indian Standards

• IS/IEC/TR 80002-3-2014 Medical Device Software - Part 3 Process Reference Model of Medical Device Software Life Cycle Processes
• IS/ISO 62304-2015 Medical Device Software — Software Life Cycle Processes

Japanese Industrial Standards Committee (JISC)

• JIS T 2304:2012 Medical device software -- Software life cycle processes
• JIS T 2304:2017 Medical device software -- Software life cycle processes

Canadian Standards Association (CSA)

• CAN/CSA-CEI/IEC 62304-2014(R2024) Medical Device Software - Software Life Cycle Processes

Swedish Institute for Standards

• SS-EN 62304:2007 Medical device software - Software life-cycle processes

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