Attention: Your browser doesn't support javascript or you have deactivated Javascript in your browser. Please enable Javascript in your browser in order to be able to use all functions of this website.

DIN SPEC

Today’s idea. Tomorrow’s standard. How is a DIN SPEC drawn up? Business plans Projects DIN SPEC Request Current DIN SPEC Drafts for commenting Withdrawn DIN SPEC

Technical rule [CURRENT]

DIN SPEC 91509
Data model for the technical documentation of medical devices - Release 1: Information related to the intended purpose of a medical device; Text in English

Title (German)

Datenmodell für die technische Dokumentation von Medizinprodukten - Release 1: Informationen im Zusammenhang mit der Zweckbestimmung eines Medizinprodukts; Text Englisch

Procedure

PAS

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.

Edition 2026-03

Original language English

Free Download

Table of contents