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Normas DIN – AENOR
DIN EN ISO 16054:2018-02

DIN EN ISO 16054:2018-02

Implants for surgery - Minimum data sets for surgical implants (ISO/DIS 16054:2017); German and English version prEN ISO 16054:2017 / Note: Date of issue 2018-01-05

Implants chirurgicaux - Ensembles minimaux de données relatives aux implants chirugicaux (ISO/DIS 16054:2017); Version allemande et anglaise prEN ISO 16054:2017 / Attention: Date de parution 2018-01-05

Chirurgische Implantate - Mindestdatensätze für chirurgische Implantate (ISO/DIS 16054:2017); Deutsche und Englische Fassung prEN ISO 16054:2017 / Achtung: Erscheinungsdatum 2018-01-05

Fecha Anulación:
2019-10 /Withdrawn
Equivalencias internacionales:

ISO/DIS 16054 (2017-12)

prEN ISO 16054 (2017-12)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 16054:2019-10

Resumen:
This international standard defines minimum data sets to facilitate recording and international exchange of data for the purposes of registry and tracking systems and for retrieval analysis. Minimum data collection requirements are specified for the purpose of implant tracking to allow recall for product correction or patient follow up in the event of unforeseen device malfunction. The minimum data set also fulfils the core data requirements to allow cross referencing between extended data sets for the purposes of retrieval analysis and research.
Keywords:
Ceramic, Ceramics, Data exchange, Data records, Definitions, Fine mechanics, Implants (surgical), Information exchange, Medical sciences, Sintered, Specification (approval), Surgery, Surgical implants
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