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Applications: regulations and requirements

Regulations and requirements with respect to Quality Assurance and Quality Control for Additive Manufacturing are discussed. The content is generic for AM, whereas industry specific chapters comprehend information about the dental, medical and aerospace industry. The full 'Applications: regulations and requirements' report can be downloaded HERE. This document is shortly summarized below.

amvaluechainapplications Design Machine Material Process Post-processing Metrology & Maintenance Quality Management System for AM

Keywords: Standards and certifications for AM, standardisation committees (ISO, ASTM, CEN), standardisation initiatives

Content

  1. Generic standards and certification for (Metal) AM
  2. Industry specific standards and certification for (Metal) AM
  3. Case studies
  4. Further reading

1. Generic standards and certifications for (Metal) AM

A key barrier for adoption of AM technology is a lack of developed standards. Especially for the application of metal parts, which are often used in highly regulated markets as the medical and aerospace market, standards specific for AM are of great value and will accelerate adoption and development of AM technology.

Several initiatives are currently involved in developing AM standards. These initiatives are:

  • ASTM, committee F 42
  • ISO (TC 261)
  • CEN (CEN/TC 438)
  • NIST

Next to this research initiatives like SASAM and other roadmaps and guidelines focus on QA and QC for AM.

ASTM, committee F 42

ASTM's Additive Manufacturing Technology standards are intended to promote knowledge of the industry, help stimulate research and encourage the implementation of technology. The standards define terminology, measure the performance of different production processes, ensure the quality of the end products, and specify procedures for the calibration of additive manufacturing machines.

The link below takes you to the ASTM pages on standardisation:

ISO (TC 261)

ISO Committee TC 261 on Additive Manufacturing Technologies was established in 2011. ISO TC261 is formed from 20 participating countries and five observer countries. The committee has four technical subcommittees:

  • ISO/TC 261/WG1 Terminology
  • ISO/TC 261/WG2 Methods, Processes, and Materials
  • ISO/TC 261/WG3 Test Methods
  • ISO/TC 261/WG4 Data Processing

The link below takes you to the ISO pages on standardisation for AM

CEN/TC 438

The CEN/TC 438 committee on Additive Manufacturing aims to (1) provide a complete set of European standards on AM, (2) To strengthen the link between European Research programs ans standardization in additive manufacturing and (3) To ensure visibility to the European standardization in additive manufacturing by centralizing standardization initiatives in Europe on additive manufacturing.

The link below takes you to the CEN/TC pages on standardisation for AM

A more detailed description of the activities and goals of CEN/TC 438 on AM can be found in the CEN/TC 438 business plan. The main activity of CEN/TC 438 is top publish the ISO standards as EN ISO, ensuring all European associated countries are obliged to work with those standards.

NIST

The NIST (National Institute of Standards and Technology U.S.) launched several research programs to develop AM standards. The links below take you the information on their programs

2. Industry specific standards and certification for (Metal) AM

Standards specific for the aerospace, dental and medical sector can be found in that specific chapters.

3. Case studies

Case studies are presented on this website for:

4. Further reading

SASAM

The European SASAM project developed a roadmap for standardisation in additive manufacturing. It encompasses long term needs as well as current industrial needs concerning standardisation of additive manufacturing technology. The roadmap was written in collaboration with ASTM, ISO and CEN, with the goal to develop a common roadmap for international standards.

The link below takes you to the ISO pages on standardisation for AM

Lloyds

Lloyds Register (LR) presents a framework for setting standards in AM. The framework consist of the following topics: abbreviations and definitions, suitability for AM, organisation requirements, training and qualifications, design, software translation, control of powder feedstock, build, post processing, inspection and testing (IP).

The link below takes you to a Lloyds guidelines document on standardisation for AM

Underwriters laboratories (UL)

The document below contains guidelines for selecting the appropriate safety standards for equipment associated with 3D printing and additive manufacturing.

Miscellaneous articles

A blog on insideadditivemanufacturing.com on standardisation activities in AM.

A scientific article discussing additive manufacturing standardisation activities. It discusses two main topics, (1) need for standards in the AM community, (2) activities carried out by ISO, ASTM and other organizations

A comprehensive overview of multiple aspects of AM. History, quality control, the process itself, material and challenges in the field of AM.

The European AMAZE project works on quality in (mainly metal) AM. AM protocols and non descructive testing protocols were designed and eveluated.

The French I-AM-SURE project focusses on parts inspection in AM (Health- Usage- Metrology- Held). This project aims to raise main obstacles deployment additive1 manufacturing industry to meet user requirements of advanced industrial sectors, developing processes guaranteeing the quality of parts. The focus is mainly on the aerospace, automotive and marine industry. The content of this project is only accessable by French companies. For two articles, see: