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ISO 10993-3:2014

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Technology

Material

Use of Standart

guideline

Branch

Medical, Medical Devices

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

EN 1642:2012-06

Dentistry - Medical devices for dentistry - Dental implants

Technology

Material

Use of Standart

guideline, specification

Branch

Medical, Medical Devices

EN 1641:2009

Dentistry - Medical devices for dentistry - Materials

Technology

Material

Use of Standart

characterisation, data sheets, guideline

Branch

Medical, Medical Devices

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

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 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 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 60265

New Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion

Technology

Powder Bed Fusion

Material

Metals

Use of Standart

guideline

Branch

Medical

WK 59813

New Guide for Hazard Risk Ranking and Safety Defense

Technology

not technology-specific

Material

not material specific

Use of Standart

guideline

Branch

not branch-specific

WK 62867

Guide for Design for Material Extrusion Processes

Technology

Material Extrusion

Material

Polymers

Use of Standart

guideline

Branch

not branch-specific

WK 65929

Additively Manufactured Spaceflight Hardware by Laser Beam Powder Bed Fusion In Metals

Technology

Laser Beam Melting

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

WK 65420

Standard Guidlines Laser Powder Bed Fusion (L-PBF) for Metal

Technology

Laser Beam Melting

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

WK 64190

Additive Manufacturing Design - Decision Guide

Technology

not technology-specific

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

WK 62946

Guide for Design for Directed Energy Deposition Processes

Technology

Direct Energy Deposition

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

VDI 3405 part 3.5

Additive Fertigungsverfahren Konstruktionsempfehlungen für die Bauteilfertigung mit Elektronen-Strahlschmelzen

Technology

Laser Beam Melting

Material

Polymers

Use of Standart

guideline

Branch

not branch-specific

VDI 3405 part 3.4

Additive manufacturing processes Ð Design rules for part production using material extrusion processes

Technology

Material Extrusion

Material

Polymers

Use of Standart

guideline

Branch

not branch-specific

VDI 3405 part 3.2

Additive manufacturing processes - Design rules - Test artefacts and test features for limiting geometric elements

Technology

not technology-specific

Material

not material specific

Use of Standart

guideline

Branch

not branch-specific

VDI 3405 part 3

Design rules for part productionusing laser sintering and laser beam melting

Technology

Laser Beam Melting

Material

Polymers

Use of Standart

guideline

Branch

not branch-specific

WK 59167

Technical Design Guideline for Powder Bed Fusion, Part 2: Laser-based Powder Bed Fusion of Polymers

Technology

Laser Beam Melting

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

WK 59131

Technical Design Guideline for Powder Bed Fusion, Part 1: Laser-based Powder Bed Fusion of Metals

Technology

Laser Beam Melting

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

WK 58220

Standard Guidance for Specifiying Gases and Nitrogen Generators used with Metal Powder Bed FusionMachines

Technology

Powder Bed Fusion

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

WK 54856

New Guide for Principles of Design Rules in Additive Manufacturing

Technology

not technology-specific

Material

not material specific

Use of Standart

guideline

Branch

not branch-specific

DIN EN ISO/PWI 23669

Corrosion of metals and alloys - Guidelines for corrosion and environmentally assisted cracking testing of additively manufactured metals and alloys

Technology

not technology-specific

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

OSO

Additive manufacturing - General principles - Overview of data processing

Technology

not technology-specific

Material

not material specific

Use of Standart

guideline

Branch

not branch-specific

DIN EN ISO/ASTM 52911-2:2020

Additive manufacturing - Technical design guideline for powder bed fusion - Part 3: Standard guideline for electron-based powder bed fusion of metals

Technology

Electron Beam Melting

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

DIN EN ISO/ASTM 52911-1:2020

Additive manufacturing - Design - Part 1: Laser-based powder bed fusion of metals

Technology

Laser Beam Melting

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

DIN EN ISO/ASTM PWI 52917

Additive manufacturing - Round robin testing - Standard guideline for conducting round robin studies

Technology

not technology-specific

Material

not material specific

Use of Standart

guideline

Branch

not branch-specific

ISO/ASTM PWI 52923

Additive manufacturing - Design decision support

Technology

not technology-specific

Material

not material specific

Use of Standart

guideline

Branch

not branch-specific

ISO/ASTM 52910:2018

Design - Requiremnets, guidelines and recommendations

Technology

not technology-specific

Material

not material specific

Use of Standart

guideline

Branch

not branch-specific

DIN ISO/ASTM CD TR 52918

Additive manufacturing - Data formats - File Format support, ecosystem and evolutions

Technology

not technology-specific

Material

not material specific

Use of Standart

data sheets, guideline

Branch

not branch-specific

ISO/ASTM TR 52912:2020

Technischer Bericht für die Gestaltung von additiv gefertigten, gradierten Bauteilen

Technology

not technology-specific

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

ISO/ASTM DIS 52931

Additive Manufacturing - Environmental health and safety - Standard guideline for use of metalic materials

Technology

Powder Bed Fusion

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

ISO/ASTM DIS 52909

Additive Fertigung - Eigenschaften von Fertigteilen - Orientierung und Lage in Abhängigkeit der mechanischen Eigenschaften für pulverbettbasierte metallische Bauteile

Technology

Powder Bed Fusion

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

DIN EN ISO 4892-1:2016-10

Kunststoffe - Künstliches Bestrahlen oder Bewittern in Geräten - Teil 1: Allgemeine Anleitung (ISO 4892-1:2016); Deutsche Fassung EN ISO 4892-1:2016

Technology

not technology-specific

Material

Polymers

Use of Standart

guideline

Branch

not branch-specific

DIN EN ISO 17296-4:2016

Additive manufacturing - General principles - Part 4: Overview of data processing

Technology

not technology-specific

Material

not material specific

Use of Standart

guideline

Branch

not branch-specific

IEEE P3333.2.5

Standard for Bio-CAD File Format for Medical Three-Dimensional (3D) Printing

Technology

not technology-specific

Material

not material specific

Use of Standart

guideline

Branch

Medical

F2971

Practice for Reporting Data for Test Specimens Prepared by AM

Technology

not technology-specific

Material

not material specific

Use of Standart

guideline

Branch

not branch-specific

DIN EN ISO/ASTM 52950:2021-05

Additive Fertigung - Grundlagen - Überblick über die Datenverarbeitung (ISO/ASTM 52950:2021); Deutsche Fassung EN ISO/ASTM 52950:2021

Technology

not technology-specific

Material

not material specific

Use of Standart

guideline

Branch

not branch-specific

F3122

Guide for Evaluating Mechanical Properties of Metal Materials Made via AM Process

Technology

Powder Bed Fusion

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

F3187-16

Standard Guide for Directetd Energy Deposition of Metals

Technology

Direct Energy Deposition

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

IEEE P3030

Standard for Consumer 3D Printing: Overview and Architecture

Technology

not technology-specific

Material

not material specific

Use of Standart

guideline

Branch

not branch-specific

F3303-18

Practice for Metal Powder Bed Fusion Process to Meet Critical Applications

Technology

Powder Bed Fusion

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

F3281-17

Additive manufacturing, Technical Design Guideline for Powder Bed Fusion, Part 2: Laser-based Powder Bed Fusion of Polymers

Technology

Laser Beam Melting

Material

Polymers

Use of Standart

guideline

Branch

not branch-specific

F3280-17

Additive manufacturing, Technical Design Guideline for Powder Bed Fusion, Part 1: Laser-based Powder Bed Fusion of Metals

Technology

Laser Beam Melting

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

DIN EN ISO 52911-2

Additive Fertigung - Technische Konstruktionsrichtlinie für Pulverbettfusion - Teil 2: Laserbasierte Pulverbettfusion von Polymeren

Technology

Laser Beam Melting

Material

Polymers

Use of Standart

guideline

Branch

not branch-specific

DIN EN ISO/ASTM 52903-2

Additive Fertigung - Normfestlegungen für die materialextrusionsbasierenden Additiven Fertigungsverfahren für Kunststoffe - Teil 2: Prozess - Zubehör

Technology

Material Extrusion

Material

Polymers

Use of Standart

guideline, specification

Branch

not branch-specific

D20.1

Standard for Fabrication of Metal Components using Additive Manufacturing

Technology

not technology-specific

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

ASTM F3187

Standard Guide for Directed Energy Deposition of Metals

Technology

not technology-specific

Material

not material specific

Use of Standart

guideline

Branch

not branch-specific

ASTM F3049-14

Standard Guide for Characterizing Properties of Metal Powders Used for Additive Manufacturing Processes

Technology

Powder Bed Fusion

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

ASTM B243-19

Standard Terminology of Powder Metallurgy

Technology

not technology-specific

Material

Metals

Use of Standart

guideline

Branch

not branch-specific

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