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Standards [CURRENT]

DIN EN ISO/IEC 17043

Conformity assessment - General requirements for the competence of proficiency testing providers (ISO/IEC 17043:2023); German and English version EN ISO/IEC 17043:2023
Edition 2023-10

Technical rule [CURRENT]

VDI 5705 Blatt 1

Digital process chains in industrial medical technology - Production of custom-made devices
Edition 2022-11

Technical Specification [CURRENT]

DIN ISO/TS 80004-7 ; DIN SPEC 52400-7:2012-07

Nanotechnologies - Vocabulary - Part 7: Diagnostics and therapeutics for healthcare (ISO/TS 80004-7:2011)
Edition 2012-07

Technical Specification

DIN CEN ISO/TS 82304-2

Health software - Part 2: Health and wellness apps - Quality and reliability (ISO/TS 82304-2:2021); German version CEN ISO/TS 82304-2:2021
Edition 2022-04

Draft technical rule [New]

DIN SPEC 91315

General requirements for plasma sources for the generation of cold atmospheric pressure plasma (CAP) for medical applications
Edition 2024-08

Administrative provision

MedPDVV

Allgemeine Verwaltungsvorschrift zur Durchführung des Medizinprodukterechts (Medizinprodukterecht-Durchführungsvorschrift - MPRVwV)
Edition 2023-06-12

Technical Specification

DIN CEN/TS 17288

Health informatics - The International Patient Summary - Guideline for European Implementation; German version CEN/TS 17288:2020
Edition 2020-08

Technical rule [CURRENT]

DIN SPEC 91380

Serious Games Metadata Format
Edition 2018-06

Technical rule [CURRENT]

DIN SPEC 13288

Guideline for the development of deep learning image recognition systems in medicine; Text in German and English
Edition 2021-03

Notice

MedPGVerzBek 2015-04

Bekanntmachung der Fundstellen von Normen gemäß § 3 Nummer 18 des Medizinproduktegesetzes (MPG)
Edition 2015-04-20

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