CR 13217:1998
(Main)Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale
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- 21-Apr-1998
- 16-Jun-2020
- 01.040.11
- 11.040.01
- CEN/CLC/TC 3
Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale
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Sistem poimenovanja medicinskih pripomočkov za obvezno izmenjavo podatkov - Utemeljitev
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.8WHPHOMLWHYNomenclature system for medical devices for the purpose of regulatory data exchange - Rationale11.040.01Medicinska oprema na splošnoMedical equipment in general01.040.11Zdravstveno varstvo (Slovarji)Health care technology (Vocabularies)ICS:Ta slovenski standard je istoveten z:CR 13217:1998SIST CR 13217:2000en01-januar-2000SIST
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This Technical Report lists collective terms and codes for groups of medical devices having common features. The listing is structured so that the terms can be used for the purposes required in regulatory reporting and for communication relevant to the application of the medical device regulation.
For certain purposes in the application of the Medical Devices Directives, there is an urgent need for the development of a list of collective terms based on the identified principles to be used, for examples, as follows:
- to illustrate the scope of certificates issued by Notified Bodies when assessing which groups, families or types of medical devices are covered within a manufacturer's quality system,
- to be used to identify the range of skills and general technological abilities for which a Notified Body has been approved, and is so appointed by the relevant Competent Authority,
- for the exchanges of information between Competent Authorities when general information on individual manufacturers capabilities is notified for inclusion in the European Database for Medical Devices (EUDAMED).
For the purpose of developing sets of collective terms, Accessories to medical devices are integrated de facto in the corresponding medical device collective term.
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This Technical Report lists collective terms and codes for groups of medical devices having common features. The listing is structured so that the terms can be used for the purposes required in regulatory reporting and for communication relevant to the application of the medical device regulation.
For certain purposes in the application of the Medical Devices Directives, there is an urgent need for the development of a list of collective terms based on the identified principles to be used, for examples, as follows:
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