Technical rule [CURRENT]
DIN SPEC 91509:2026-03
Data model for the technical documentation of medical devices - Release 1: Information related to the intended purpose of a medical device; Text in English
- German title
- Datenmodell für die technische Dokumentation von Medizinprodukten - Release 1: Informationen im Zusammenhang mit der Zweckbestimmung eines Medizinprodukts; Text Englisch
- Publication date
- 2026-03
- Accessibility
- Product with additional digital content.
-
PDF, Further digital supplements
Additional digitale content will be provided based on format and purchase option. Please note any information in the document. - Original language
- English
- Pages
- 33
- Procedure
- PAS
- Publication date
- 2026-03
- Product with additional digital content.
-
PDF, Further digital supplements
Additional digitale content will be provided based on format and purchase option. Please note any information in the document. - Original language
- English
- Pages
- 33
- Procedure
- PAS
- DOI
- https://dx.doi.org/10.31030/3670189
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Overview
This document defines terms, definitions, and general requirements for a data model intended for categorization of information in the technical documentation of medical devices. This includes: a provision of general information about the background of the project and expected benefits; - a description of the data model development procedure; information about the data model structure; - a first collection of data model elements that belong to the “intended purpose information collection” (first release); - information about the initial application of the data model and feedback collection. This DIN SPEC has been developed according to the PAS procedure. The development of a DINSPEC according to the PAS procedure is carried out in DIN-SPEC-consortiums and does not require the participation of all stakeholders.