qualification – WE BOOST AM

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Polymers

Elastic Polymers

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IEC 62304:2006

Medical device software — Software life cycle processes

Technology

not technology-specific

Material

Use of Standart

guideline, qualification, specification

Branch

Medical, Medical Devices

ASTM F3571-22

Standard Guide for Additive Manufacturing – Feedstock – Particle Shape Image Analysis by Optical Photography to Identify and Quantify the Agglomerates/Satellites in Metal Powder Feedstock

Technology

not technology-specific

Material

Use of Standart

qualification

Branch

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

ISO 14971

Medical devices — Application of risk management to medical devices

Technology

not technology-specific

Material

not material specific

Use of Standart

guideline, qualification

Branch

Medical, Medical Devices

DIN EN ISO 10328

Structural testing of lower-limb prostheses – Requirements and test methods

Technology

not technology-specific

Material

not material specific

Use of Standart

qualification

Branch

Prosthesis

DIN EN ISO 22523

External limb prostheses and external orthoses – Requirements and test methods

Technology

not technology-specific

Material

not material specific

Use of Standart

certification, guideline, qualification

Branch

Orthoses

DNV-ST-B203

This standard (ST) specifies requirements and guidance for:

- the qualification of parts made by additive manufacturing (AM) for the oil and gas and related industries
- the purchasing of AM parts
- quality management for manufacturers of AM parts
- the manufacturing of AM parts.

Technology

Material

Metals

Use of Standart

guideline, qualification

Branch

Gas & Oil

WK 65937

Control and Qualification of Laser Beam Powder Bed Fusion Process

Technology

Laser Beam Melting

Material

Metals

Use of Standart

qualification

Branch

not branch-specific

VDI 3405 part 6.1

User safety on operating the manufacturing facilities - Laser beam melting of metallic parts

Technology

Laser Beam Melting

Material

Metals

Use of Standart

qualification

Branch

not branch-specific

NP 52936-1

Qualification principles - Laser-based powder bed fusion of polymers - Part 1: General principles, preparation of test specimens

Technology

Laser Beam Melting

Material

Polymers

Use of Standart

qualification

Branch

not branch-specific

VDI 3405 part 2

Beam melting of metallic parts - Qualification, quality assurance and post processing

Technology

not technology-specific

Material

Metals

Use of Standart

qualification

Branch

not branch-specific

VDI 3405 part 1.1.

Additive Fertigungsverfahren
Laser-Sintern von Kunststoffbauteilen
Materialqualifizierung

Technology

Laser Beam Melting

Material

Polymers

Use of Standart

qualification

Branch

not branch-specific

VDI 3405 part 1

Additive Fertigungsverfahren - Laser-Sintern von Kunststoffbauteilen - Gteberwachung

Technology

Laser Beam Melting

Material

Polymers

Use of Standart

qualification

Branch

not branch-specific

ISO/ASTM CD 52935

Additive manufacturing of metals — Qualification principles — Qualification of coordinators for metallic parts production

Technology

not technology-specific

Material

Metals

Use of Standart

qualification

Branch

not branch-specific

DIN EN ISO/ASTM TS 52930:2021

This document addresses installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) issues directly related to the additive manufacturing system that has a direct influence on the consolidation of material. The first three elements of process validation, process mapping, risk assessment, and validation planning, are necessary pre-conditions to machine qualification, however, they are outside the scope of this document.

This document covers issues directly related to the AM equipment and does not cover feedstock qualification or post processing beyond powder removal.

Physical facility, personnel, process and material issues are only included to the extent necessary to support machine qualification.

Technology

Laser Beam Melting

Material

not material specific

Use of Standart

qualification

Branch

not branch-specific

DIN EN ISO/ASTM 52903-2:2021

Additive manufacturing - Material extrusion based additive manufacturing of plastic materials - Part 2: Process equipment

Technology

Material Extrusion

Material

Polymers

Use of Standart

qualification

Branch

not branch-specific

DIN EN ISO/ASTM 52903-1:2021

Additive manufacturing — Material extrusion-based additive manufacturing of plastic materials — Part 1: Feedstock materials

Technology

Material Extrusion

Material

Polymers

Use of Standart

qualification

Branch

not branch-specific

DIN EN ISO/ASTM 52925:2020-05

Additive manufacturing processes - Laser sintering of polymer parts/laser-based powder bed fusion of polymer parts - Qualification of materials

Technology

Laser Beam Melting

Material

Polymers

Use of Standart

qualification

Branch

not branch-specific

DIN EN ISO/ASTM 52904:2020

Additive Fertigung - Prozessanforderungen und Qualifizierung - Verwendung des pulverbettbasierten Schmelzens von Metallen bei kritischen Anwendungen

Technology

Powder Bed Fusion

Material

Metals

Use of Standart

qualification

Branch

not branch-specific

DIN EN ISO/ASTM 52920:2021

Additive manufacturing — Qualification principles — Requirements for industrial additive manufacturing sites

Technology

not technology-specific

Material

not material specific

Use of Standart

qualification

Branch

not branch-specific

DIN EN ISO/ASTM 52924:2020

Additive manufacturing - Qualification principles - Classification of part properties for additive manufacturing of polymer parts

Technology

not technology-specific

Material

Polymers

Use of Standart

qualification

Branch

not branch-specific

DIN EN ISO/ASTM 52942

Additive manufacturing - Qualification principles - Qualifying machine operators of metal powder bed fusion machines and equipment used in aerospace applications

Technology

Powder Bed Fusion

Material

Metals

Use of Standart

qualification

Branch

Aerospace, Mobility

DIN EN ISO 52924

Additive Fertigung - Qualifizierungsgrundsätze - Güteklassen für additiv gefertigte Kunststoffbauteile

Technology

Laser Beam Melting, Material Extrusion, Powder Bed Fusion

Material

Polymers

Use of Standart

qualification

Branch

not branch-specific

DIN EN ISO 52925

Additive Fertigung - Qualifizierungsgrundsätze - Qualifizierung von Kunststoffen für pulverbettbasiertes Schmelzen mit einem Laser

Technology

Laser Beam Melting, Material Extrusion, Powder Bed Fusion

Material

Polymers

Use of Standart

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

DIN 65124:2018-10

Luft- und Raumfahrt Ð Technische Lieferbedingungen fr additive Fertigung metallischer Werkstoffe mit Pulverbettverfahren

Technology

Powder Bed Fusion

Material

Metals

Use of Standart

qualification

Branch

Aerospace, Mobility

DIN 65122:2017-01

Luft- und Raumfahrt Ð Pulver zur Verwendung fr die additive Fertigung mittels Pulverbettverfahren Ð Technische Lieferbedingungen

Technology

Powder Bed Fusion

Material

Metals

Use of Standart

qualification

Branch

Aerospace, Mobility

DIN 35224

Schwei§en im Luft- und Raumfahrzeugbau - Abnahmeprfzeugnis von pulverbettbasierten Laserstrahlmaschinen zur additiven Fertigugn

Technology

Laser Beam Melting

Material

not material specific

Use of Standart

qualification

Branch

Aerospace, Mobility

DIN 17024-2

Additive Fertigung - Prozessanforderungen und Qualifizierung - Teil 2: Materialauftrag mit gerichteter Energieeinbringung unter Verwendung von Draht und Lichtbogen in der Luft- und Raumfahrt

Technology

Direct Energy Deposition

Material

Metals

Use of Standart

qualification

Branch

Aerospace, Mobility

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