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EN ISO 10993-1:2021

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Technology

Material

Use of Standart

guideline, test method

Branch

Medical, Medical Devices

DIN EN ISO 14971

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

Technology

Material

Use of Standart

certification, characterisation, guideline, personal qualification, qualification, specification

Branch

Medical, Medical Devices

EN ISO 13485

Medical devices — Quality management systems — Requirements for regulatory purposes

Technology

Material

Use of Standart

certification, guideline, qualification

Branch

Medical, Medical Devices

EN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice

Technology

Material

Use of Standart

guideline

Branch

Medical, Medical Devices

ISO/ASTM DIS 52926-5

Additive Manufacturing of metals — Qualification principles — Part 5: Qualification of operators for DED-Arc

Technology

Direct Energy Deposition

Material

Metals

Use of Standart

personal qualification

Branch

not branch-specific

ISO/ASTM DIS 52926-4

Additive manufacturing - Qualification principles - Qualifying machine operators for metallic parts production for DED-LB

Technology

Direct Energy Deposition

Material

Metals

Use of Standart

personal qualification

Branch

not branch-specific

ISO/ASTM DIS 52926-3

Additive manufacturing - Qualification principles - Qualifying machine operators for metallic parts production for PBF-EB

Technology

Electron Beam Melting

Material

Metals

Use of Standart

personal qualification

Branch

not branch-specific

ISO/ASTM DIS 52926-2

Additive manufacturing - Qualification principles - Qualifying machine operators for metallic parts production for PBF-LB

Technology

Laser Beam Melting

Material

Metals

Use of Standart

personal qualification

Branch

not branch-specific

ISO/ASTM DIS 52926-1

Additive manufacturing - Qualification principles - Qualifying machine operators for metallic parts production

Technology

Laser Beam Melting

Material

Metals

Use of Standart

personal qualification

Branch

not branch-specific

DVS 3602-1

ãDVS-Lehrgang: Fachkraft fr Additive Fertigungsverfahren Ð Fachrichtung MetallÒ

Technology

not technology-specific

Material

Metals

Use of Standart

personal qualification

Branch

not branch-specific

DVS 3601-1

ãDVS-Lehrgang: Fachkraft fr Additive Fertigungsverfahren Ð Fachrichtung KunststoffÒ

Technology

not technology-specific

Material

Polymers

Use of Standart

personal qualification

Branch

not branch-specific

DIN 35225

Schwei§en im Luft- und Raumfahrzeugbau - Prfen von Bedienern fr pulverbettbasierte Laserstrahlanlagen zur additiven Fertigung

Technology

Laser Beam Melting

Material

Metals

Use of Standart

qualification

Branch

Aerospace, Mobility

DVS 3603

ãDVS-Bildungseinrichtungen auf dem Gebiet âAdditive FertigungsverfahrenÔ Ð Zulassung Ò

Technology

not technology-specific

Material

not material specific

Use of Standart

personal qualification

Branch

not branch-specific

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