STANDARDS ------------------------------------------------------------------------------------------------------------------------ International Organisation for Standardization (ISO) ISO Standards for Healthcare Technology. National Standards Bodies Deutsches Institut für Normung (DIN) EUCOMED (European Confederation of Medical Devices Associations)

MEDICAL STANDARDS ------------------------------------------------------------------------------------------------------------------------ European Research Group on Health Outcomes Digital Imaging and Communications in Medicine (DICOM) ARDEN SYNTAX

STANDARDS ORGANISATIONS BY COUNTRY ------------------------------------------------------------------------------------------------------------------------ Argentina: Instituto Argentino de Normalización (IRAM) Austria: Österreichisches Normungsinstitut (ON) Belgium : Institut Belge de Normalisation (IBN) Canada: Standards Council of Canada (SCC) Colombia: Instituto Colombiano de Normas Técnicas y Certificación (ICONTEC) Croatia: State Office for Standardization and Metrology (DZNM) Czech Republic: Czech Standards Institute (CSNI) Denmark: Dansk Standard (DS) Finland: Finnish Standards Association (SFS) France: Association française de normalisation (AFNOR) Germany: Deutsche Elektrotechnische Kommission im DIN und VDE (DKE) Germany: Deutsches Institut für Normung (DIN) Germany: HL7 Benutzergruppe in Deutschland Germany: International Classifikation of Procedures in Medicine (german version) Greece: Hellenic Organization for Standardization (ELOT) Iceland: Icelandic Council for Standardization (STRI) Ireland: National Standards Authority of Ireland (NSAI) Italy: Ente Nazionale Italiano di Unificazione (UNI) Luxemburg: Service de l'Energie de l'Etat (SEE) Malaysia: Department of Standards Malaysia (DSM) Morocco: Service de normalisation industrielle marocaine (SNIMA) Netherlands: Netherlands Normalisiate-Instituut (NNI) New Zealand: Standards New Zealand (SNZ) Norway: Norges Standardiseringsforbund (NSF) Portugal: Instituto Português da Qualidade (IPQ) Saudi Arabia: Standards Organization (SASO) Slovenia: Standards and Metrology Institute (SMIS) Spain: Asociación Española de Normalización y Certificación (AENOR) Sweden: Standardiseringen i Sverige (SIS) Switzerland: Swiss Association for Standardization (SNV) United Kingdom: British Standards Institution (BSI) USA: American National Standards Institute (ANSI) Viet Nam: Directorate for Standards and Quality (TCVN)

ASSOCIATIONS ------------------------------------------------------------------------------------------------------------------------ European Confederation of Medical Device Associations European Commission European Commission - Directorate General III European Commission - Directorate General XI Irish Medical Device Association (IMDA) Medical Device Manufacturers Association (MDMA) Medical Devices Canada (MEDEC)

GERMANY ------------------------------------------------------------------------------------------------------------------------ DIMDI - Deutsches Institut für medizinische Dokumentation und Information Law on Medical Devices Clinical Investigation Notification Competent Authorities (Germany) - Addresses and Codes EUDAMED Database Access Ethic committees registration Forms Incident/Near Incident Reporting Legal Tasks of DIMDI Notifications Universal Medical Device Nomenclature System (UMDNS) (German) Deutsche Elektrotechnische Kommission im DIN und VDE (DKE) Deutsches Institut für Normung (DIN)

DIRECTIVES AND GUIDELINES ---------------------------------------------------------------------------------------------------------------------------------------------------------------- Directive 93/42/EEC of 14 June 1993 concerning medical devices Guidelines relating to the demarcation between Directives 90/385/EEC, 93/42/EEC and 65/65/EEC Guidelines on a Medical Devices Vigilance System Directive 98/79/EC of the European Parliament & the Council of 27 Oct 98 on in vitro diagnostic medical devices List of references to harmonised standards - in vitro diagnostic medical devices