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Global Medical Device Nomenclature - Flinders University

GMDN User Guide: version 2002. GMDN. Global Medical Device Nomenclature User Guide - Version 2002. GMDN 2002 All Rights Reserved This User Guide is approved by the GMDN MA Policy Group and is applicable to the GMDN versions: GMDN Beta GMDN To: find out more about the information contained in this User Guide access the constantly updated GMDN information service submit a query, suggestion, order or donation go to the GMDN website at 1. GMDN User Guide: version 2002. Contents 1. INTRODUCTION .. 6. BACKGROUND .. 6. SCOPE .. 7. ACKNOWLEDGEMENTS .. 7. COPYRIGHT .. 8. DISCLAIMER:.. 8. COMMENTS .. 9. 2. THE GMDN 10. WHY THIS Nomenclature ?

medical devices suitable for use by all interested parties globally. On the 1 st of November 2001 the Global Medical Device Nomenclature (GMDN) was published as

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Transcription of Global Medical Device Nomenclature - Flinders University

1 GMDN User Guide: version 2002. GMDN. Global Medical Device Nomenclature User Guide - Version 2002. GMDN 2002 All Rights Reserved This User Guide is approved by the GMDN MA Policy Group and is applicable to the GMDN versions: GMDN Beta GMDN To: find out more about the information contained in this User Guide access the constantly updated GMDN information service submit a query, suggestion, order or donation go to the GMDN website at 1. GMDN User Guide: version 2002. Contents 1. INTRODUCTION .. 6. BACKGROUND .. 6. SCOPE .. 7. ACKNOWLEDGEMENTS .. 7. COPYRIGHT .. 8. DISCLAIMER:.. 8. COMMENTS .. 9. 2. THE GMDN 10. WHY THIS Nomenclature ?

2 11. THE USERS .. 11. 3. DEFINITIONS .. 15. 4. STRUCTURE .. 18. 4. 1 THE Nomenclature STRUCTURE .. 18. 4. 1. 1. The general data structure .. 18. ATTRIBUTES .. 19. 4. 2. Device CATEGORY .. 19. 4. 2. Device CATEGORY .. 20. 4. 3. GENERIC Device GROUP .. 20. Preferred terms .. 21. Template terms .. 22. 4. 3. 3. Synonym 23. 4. 3. 4. Example of style .. 24. Device TYPE .. 25. CODING .. 26. PREFERRED TERM STRUCTURE .. 27. Base concept 28. TERM 29. 5. APPLICATION .. 30. INSTALLATION .. 30. File format .. 31. 5. 2. 33. 5. 2. 34. 5. 2. 1. WHO SHOULD CLASSIFY? .. 34. HOW TO 34. 5. 2. 3. Classification of 41. 5. 2. 4. Category selection method.

3 42. No GMDN term available .. 43. Classification hints & tips .. 43. 6. 46. 6. 1. RULES AND CONVENTIONS FOR Nomenclature DEVELOPMENT .. 46. 2. GMDN User Guide: version 2002. ABBREVIATIONS .. 54. GLOSSARY OF TERMS .. 61. SEARCH WORDS BY QUALIFIERS .. 68. BIBLIOGRAPHY .. 69. FORM A (READER'S COMMENT FORM) .. 71. FORM B (GMDN PROPOSAL FORM).. 71. FORM B (GMDN PROPOSAL FORM).. 72. INSTRUCTIONS FOR FILLING IN THE GMDN PROPOSAL FORM .. 76. 3. GMDN User Guide: version 2002. Index A ISO 10. 54. 44. J. Alphabetical search .. 35 10. Application .. 30 L. B Lowercase .. 24. Base concept construction .. 28 M. C Maintenance 7, 8. Category selection search.

4 36 75. Character .. 15 Manufacturer .. 12, 17. , 43 75. CNMD .. 10 N. Coding .. 26. 9 Name .. 16. Competent Authorities .. 7, 12 Navigation - See Synonym terms and Concept .. 15 or Template terms Conventions for Nomenclature Navigational search .. 35. Development .. 46 NKKN .. 10. Copyright .. 8 Nomenclature .. 11, 16. Custom made Device .. 16 Nomenclature structure .. 18. Notified 7, 12. D. P. Data relational .. 18. Definitions .. 15 Preferred term .. 16, 21. Descriptor .. 28 Preferred term structure .. 27. Device category ..15, 20 Procedure 44. Device type .. 15, 18, 25 Punctuation .. 25. Disclaimer .. 8 Q. E Qualifier.

5 27. ECRI .. 10 R. 10. Relational structure .. 16, 33. F. S. File .. 15. File 31 45. Standard EN ISO 15225 .. 18, 20. G Standard EN ISO 15225 Annex C .. 23. Generic Device , 20 Synonym .. 16. Glossary of terms .. 61 Synonym 23. GMDN .. 11 Systems .. 45. I T. Installation .. 30 Template term .. 16, 22. 4. GMDN User Guide: version 2002. 16 Uppercase .. 24. Term selection .. 39 Users .. 11. Term specificity .. 29 W. Trade 75. Word search .. 36. U Word search facility .. 28. UMDNS .. 10. 5. GMDN User Guide: version 2002. 1. Introduction Recent work by the standards organizations CEN and ISO have resulted in a standard for building a Nomenclature for Medical devices .

6 This standard is published as EN ISO 15225 Nomenclature Specification for a Nomenclature system for Medical devices for the purpose of regulatory data exchange. Following this a project was set up by CEN with financial support from the European Commission. The aim of the project being to create a comprehensive Nomenclature for all Medical devices suitable for use by all interested parties globally. On the 1st of November 2001 the Global Medical Device Nomenclature (GMDN) was published as CEN Report CR 14230 and as 20225. The Nomenclature is officially named by its governing technical committee to be: GMDN ( Global Medical Device Nomenclature ).

7 Background Many nomenclatures for Medical devices and healthcare products exist on a worldwide basis having been created with different approaches, structures, and for different purposes. In spite of this little has been achieved regarding the possibility of unambiguously classifying Medical devices . These different nomenclatures, though often workable in their own right, have had no impact on improving the overall situation of providing a common platform whereby Medical devices can be unambiguously identified and related data safely exchanged. For the manufacturer, having to deal with the different national and international requirements regarding classification can be a nightmare scenario.

8 Many of the larger manufacturers simply use their own in-house product identification scheme and, whilst this approach may work extremely well for them, it is likely to be incompatible with and unusable for others. The medium and small size manufacturers experience even greater difficulties, but simply try to carry on as best they can. The running and application of different nomenclatures worldwide is extremely time-consuming and expensive; this without improving the data quality to the level required by modern data communication. With the advent of the European Union (EU) Directives for Medical devices , a new era was initiated where both national and international bodies, are given the opportunity to co-operate and harmonise efforts to achieve something that they all need.

9 Within all regulations concerned with Medical devices there are a number of obligations placed on the manufacturer. In addition, the authorities are faced with the task of regulating manufacturers and their devices , and there are people involved in trade with these devices , suppliers, before the devices themselves are finally brought into use. Finally, of course, there is the myriad of users who, when the devices initially arrive, struggle with the quite hopeless task of trying to correctly classify the devices . This means that there are a number of players, all of whom have quite different responsibilities, but all with the common interest of ensuring the availability of sound Medical devices .

10 To assist this important process 6. GMDN User Guide: version 2002. there is a need for a common method for describing and identifying these Medical devices in an unambiguous manner. Consequently, as Medical devices are manufactured, distributed, and brought into use worldwide, it has been necessary to develop the GMDN as the new Global Nomenclature for Medical devices . Scope The GMDN is a Nomenclature , the purpose of which is to enable Competent Authorities (CA), Notified Bodies (NB) and manufacturers to meet the requirements of Council Directives on Medical devices . The GMDN is also intended to assist in the implementation of community sectorial legislation and to facilitate co-operation and exchange of information within the European Community and at an international level.


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