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1 EN 62304 2006 MDD 93/42/EEC 1 2013 4 5 2 3 5 2 7 EN 62304 7 12 14 19 21 27 SOUP 31 34 1 35 2 SOUP 36 3 39 4 COCIR 2011 40 43 3 FAQ 62304 IEC 62304 2006 EN 62304 3 AIMD 90/385/EEC MDD 93/42/EEC IVDD 98/79/EC EN 62304 2006 NB NB NB NB 7 73 IEC 62304 IEC/ISO NB Jomuna Choudhuri VDE Testing and Certification Institute Koen Cobbaert Agfa Healthcare Georg Heidenreich Siemens AG-Healthcare Sector Frans Jacobs Philips Healthcare Gerd Neumann Siemens AG-Healthcare Sector Michael Bothe VDE Testing and Certification Institute Peter Linders Chair

2 Technical & Regulatory Affairs Committee, COCIR FAQ FAQ 4 IEC 62304 [ ] 5 IEC 62304 AIMDD Active Implantable medical Device Directive CMS Configuration Management System COCIR European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry COTS Commercial off-the-shelf ( ) EEC European Economic Community ( ) EUROM VI European Federation of Precision Mechanical and Optical Industries - medical Technology ( ) FPGA Field Programmable Gate Array ( ) GPO General Practitioner s Office ( ) IEC International Electrotechnical Commission ( ) ISO International Organization for Standardization ( ) IVDD In-Vitro Diagnostic Directive ( ) MDD medical Device Directive ( ) MEDDEV Non-binding guidance for medical Devices, endorsed by EU Member States (EU ) MPBetreibV Medizinprodukte - Betreiberverordnung Verordnung uber das Errichten, Betreiben und Anwende ( )

3 6 NB notified body , notified bodies NB PEMS Programmable Electrical medical System SAAS Software as a service SDD Software Detailed Design SIL Safety Integrity Levels as per IEC 61508 IEC 61508 SOUP Software of Unknown Provenance T V Technischer berwachungsverein VDE Verband der Elektrotechnik, Elektronik und Informationstechnologien 7 EN 62304 EN 62304 MDD( 93/42/EEC) 3 MDD MEDDEV 2 a) SAAS b) FPGA c) FPGA d) e) medical Apps f) (Excel macros) g) h) i) j)

4 [Intended Use] a) SAAS 8 expertise decision MDD MDD b) FPGA FPGA EN 62304 c) FPGA FPGA IEC 62304 d) 2007 MDD [Intended Use] e) MDD EN 62304 f) MDD EN 62304 MPBetreibV g) h) 9 i) j)

5 MDD SOUP MDD EN 62304 NB EN 62304 private IT EN 62304 EN 62304 IT EN 62304 FDA EN 62304 PEMS EN 60601-1 3 14 IEC 82304 [ ISO/IEC 82304-1 Healthcare software systems -- Part 1.]

6 General requirements ] EN ISO 13485 2012 ISO 13485 EN 62304 FDA EN 62304 [Intended Use] 10 EN 62304 MDD EN 60601-1 3 14 MDD EN ISO 13485 EN 62304 NB EN 62304 MDD [the current state of the art]

7 NB EN 62304 A EN 62304 IEC 62304 2 MDD 2 1 11 A A EN 62304 A A IEC 60601-1-4 PEMS IEC 60601-1 14 EN 62304 IEC 62304 2015 IEC 60601 IEC 62304 IEC 60601 IEC 62304 IEC 82304 IEC 82304 3

8 EN 62304 IEC/CD 82304 12 MDD EN 62304 EN 62304 MDD I EN 62304 EU [Intended Use] [Intended Use] MDD GPSD MEDDEV 4 a) IIb III MDD III+V III+IV b) IEC 62304 NB a) 11 IIb III II III+IV V MDD b)

9 QMS MDD EN 62304 13 NB EN 62304 EN 62304 IEC 62304 / IEC 62304 FDA 13 8 YY/T 0664 .pdf EN 62304 ISO 13485.

10 Pdf a) EN 62304 MDD IX b) EN 62304 a) [Intended Use] MDD b) EN 62304 NB NB NB ISO/IEC 17021 NB ISO 9001/ISO 13485/ EN 62304 14 ISO/IEC 17025