AMSC Gaps Portal

Qualification & Certification Section

Updates have been made to the following gaps:

One of the challenges in discussing qualification and certification in AM is the ambiguity of the terms qualification, certification, verification, and validation, and how these terms are used by different industrial sectors when describing Q&C of materials, parts, processes, personnel, and equipment.

R&D Needed: No

Recommendation: Compare how the terms qualification, certification, verification and validation are used by industry sector. Update as needed existing quality management system standards and other terminology standards to harmonize definitions and encourage consistent use of terms across industry sectors with respect to AM.

Priority: High.

Organization: ASTM F42/ISO TC 261, AAMI, ASME, SAE

Status of Progress: Green

Update: In discussions between the AMSC advisory group and the SDOs, there was a general sense that relevant AM terminology could be captured in the ISO/ASTM 52900 document to the extent possible. However, that document does not currently address the disparities on Q&C terminology discussed here. As a general matter, ASME has been coordinating AM terminology activity with ASTM. SAE has noted the challenges of coming to consensus on terminology and has been using the ASTM definitions when they exist but coming up with new terms for aerospace applications when a term is not defined. ASTM has offered to convene a virtual meeting with the SDOs and technical experts to discuss terminology. America Makes could help to promote such collaboration. This would be a step forward though it may not solve the issue of getting different sectors to adopt the same terminology.

A part classification system is used to describe the level of risk associated with a part and may therefore be used as a metric to gauge appropriate qualification requirements. A common classification system for AM parts by industry sector is needed to provide consistent evaluation criteria for AM part risk. This should include a definition of criticality levels. Consistent risk criteria provide the basis for consistent expectations and levels of qualification rigor. Examples of classification systems can be found in NASA’s MSFC-STD-3716, Standard for Additively Manufactured Spaceflight Hardware by Laser Powder Bed Fusion in Metals, and the draft AWS D20.1 standard, which utilizes the part classification system identified in AWS D17.1/D17.1M:2017-AMD1, Specification for Fusion Welding of Aerospace Applications. Any industry requiring rigorous AM part qualification and system certification would benefit from a common part classification system.

R&D Needed: No

Recommendation: A technical report describing existing classification systems for AM parts would be useful. It could include the recommended minimum process and part qualification requirements commensurate with part risk for each classification level.

Priority: High

Organization: ASTM F42/ISO TC 261, AWS, DoD, FAA, NASA, SAE

Status of Progress: Green

Update: ASTM F42.01 will explore developing this technical report. This will require coordination between the SDOs and relevant federal agencies. It may also be application-specific (e.g., spaceflight, military, etc.) This is more a harmonization issue. Procurement and level of testing required need to be addressed. The primary beneficiaries will be industry.

4/4/2019, LY: The AWS recently published a new standard on AM, AWS D20.1/D20.1M:2019 Specification for Fabrication of Metal Components using Additive Manufacturing.

In order to enable full understanding of the given processes and to include this type of information in a process-agnostic TDP, and for purposes of qualification and/or certification, there must be standardization of process parameter terminology across machine manufacturers.

R&D Needed: No

Recommendation: Develop standardized terminology for process parameters for use across all AM equipment. Potentially, incorporate these into ISO/ASTM 52900:2015, Additive manufacturing - General principles - Terminology. See also Gap PC5 on parameter control.

Priority: Medium

Organization: ASTM F42/ISO TC 261 JG 51, AWS D20, SAE AMS-AM, IEEE-ISTO PWG

Status of Progress: Green

Update: As noted in the text.

As multiple methods of AM continue to mature, and new AM techniques are introduced, the government will need to fully understand the ramifications of each of these techniques, of what they are capable, and how certain AM procedures might lend themselves to some classes of parts and not others. Thus, not only must the government understand the differences, but how they should be assessed and tested, and what additional checks must be made on the end product before it can be qualified for use in a military platform. High pressures, temperatures, and other contained environments could impact the performance or life of safety-critical parts in ways that are not understood. More research is required to determine the delta between traditional and AM methods.

&D Needed: Yes

Recommendation: Starting with the most mature technologies, such as laser powder bed, there is a need to develop standards that assess required checks for levels of criticality and safety as part of the DoD procurement process. DoD should participate in the development of such standards and specify the certification requirements needed.

Priority: Medium

Organization: ASME, ASTM F42/ISO TC 261, DoD, Industry, SAE, Service SYSCOMS

Status of Progress: Yellow

Update: DoD is holding AM business model workshops, the agenda for which includes developing an AM contracting guide for the Navy/DoD. None provided vis a vis work by the SDOs.

There is a need for standards or guidelines outlining AM training requirements.

R&D Needed: No

Recommendation: Develop AM operator training and qualification standards or guidelines. Training should cover the various AM materials and processes available in the market and be performance based to ensure consistent AM part quality. Develop additional standards for artisanal levels of competency and experience, delineating an individual’s expertise in the field or subsets of the AM field.

Priority: Low

Organization: NASA, SAE, AWS, OEMs, UL, ASTM F42/ISO TC 261, AAMI

Status of Progress: Green

Update: As noted in the text.

The DICOM standard needs to be more widely promoted and may need to be revised to enable data to be imported from any ultrasound equipment similar to the CT scan or MRI data. There is a concern that the data coming from the ultrasound may not be providing adequately detailed images but this cannot be assessed until the interoperability concerns are eliminated.

R&D Needed: Yes

Recommendation: Promote and potentially revise the DICOM standard for importing data from ultrasound equipment. Use cases are obstetrics and pre-natal diagnosis. CP 1071 correction proposals should be approved. This relates to codes for cardiac ultrasound data target sites.

Priority: Medium

Organization: DICOM, IEEE, ASTM F42/ISO TC 261 JG 70

Status of Progress: Green

Update: ISO/ASTM NP 52916, Additive manufacturing -- Data formats -- Standard specification for optimized medical image data, is being developed by ASTM F42 and ISO/TC 261 as JG 70.

Problems associated with data acquisition for 3D modeling either individually or in combination contribute to image inaccuracies that will result in inaccuracies of the 3D model and eventually the final device produced.

R&D Needed: Yes. More R&D is needed on data for image accuracy before a standard can be developed.

Recommendation: Develop standard protocols for acquiring data for 3D modeling to ensure image accuracy. They may make use of standard image formats that capture enough information to facilitate size, orientation and color normalization and/or validation in post-processing of data.

Priority: Medium

Organization: DICOM, IEEE, ASME, ASTM F42/ISO TC 261, RSNA (Radiological Society of North America)

Status of Progress: Green

Update: ISO/ASTM NP 52916, Additive manufacturing -- Data formats -- Standard specification for optimized medical image data, is being developed by ASTM F42 and ISO/TC 261 as JG 70.

Material and process guidelines are needed for phantoms to provide reliable models for imaging experiments and to check the accuracy of the process. These would include which materials and AM process to use, based on what is being imaged and the modality in use (e.g., X-ray vs. ultrasound).

R&D Needed: Yes.

Recommendation: Develop guidelines for creating and using phantoms to include material and process used, based on use. Similar to Gap QC7, they may make use of standard image formats that capture enough information to facilitate size, orientation and color normalization and/or validation in post-processing of data.

Priority: Medium

Organization: Biomedical Engineering Society, NEMA/MITA, ISO, ASTM, RSNA

Status of Progress: Green

Update: The RSNA 3DP Special Interest Group (SIG) is developing best practices for phantoms.

Currently, there are only limited qualification or certification programs (some are in process of formation) available for training personnel who are handling imaging data and preparing for AM printing.

R&D Needed: No

Recommendation: Develop certification programs for describing the requisite skills, qualification, and certification of personnel responsible for handling imaging data and preparing for printing. The SME organization currently has a program in development.

Priority: High

Organization: SME, RSNA, ASTM F42/ISO TC 261

Status of Progress: Green

Update: The SME AM3DP medical WG has developed competency models and is working on a detailed body of knowledge (BOK) to help recruit skilled workers to the profession, along with training, curriculum development, and a certification program. The FDA is involved with SME and RSNA. There is no separate interest at the federal level; certifications happen at the state level.

There are currently no standards for the final verification of a 3D model before it is approved for AM for the intended purpose (e.g., surgical planning vs. implantation; cranial replacement piece; cutting guides which have a low tolerance for anatomical discrepancy).

R&D Needed: Yes, in terms of tolerances

Recommendation: Develop standards for verification of the 3D model against the initial data. Ideally, they should identify efficient, automatable methods for identifying discrepancies.

Priority: High

Organization: ASTM F42/ISO TC 261, NEMA/MITA, AAMI, ASME, NIST, ACR

Status of Progress: Green

Update: ASTM F42/ISO 261 are looking at image quality as part of the model verification. ASME V&V 40 addresses verification and validation in computational modeling of medical devices. This issue requires cooperation between clinical societies, the FDA and industry. It may also be a general, not only medical, concern.

Testing of degradation of the new resorbable metals/polymers in living tissues cannot be adequately achieved using existing standards.

R&D Needed: Yes, in terms of rate and amount of degradation for new polymers and resorbable metals.

Recommendation: Develop guidance on how to test the degradation of new resorbable metals/polymers to support material selection for AM.

Priority: Medium

Organization: ASTM F4, ISO, ISO/TC 150, ISO/TC 194

Status of Progress: Green

Update: None provided

There is a need for well-established material control data and procedures. Materials are primarily manufactured through proprietary methods and, while recommended handling practices exist for each company and each product, standard procedures or standardized considerations are not available.

R&D Needed: Yes

Recommendation: A standard or specification describing a data set for material pedigree, recommended testing, and handling procedures would simplify evaluation of material suitability.

Priority: Low

Organization: Material providers, ASTM

Status of Progress: Unknown

Update: None provided

There are currently no standards for patient imaging files including the methods from standard-of-care medical images to print-ready files. There is no group or entity that oversees segmentation within a clinical setting. RSNA has a special interest group that may set standards for segmentation and/or 3D printing. DICOM WG 17 also is looking at this.

R&D Needed: No

Recommendation: There is a need to create an augmented file specification for the DICOM file format. Incorporation of 3D files into the DICOM format will facilitate integration of 3D models into standard-of-care medical image databases present at all institutions. 3D models should include enough information to facilitate standardized methods for validation.

Priority: Medium

Organization: RSNA, DICOM, ASTM

Status of Progress: Green

Update: DICOM is addressing most of this. They will have public comment by the end of 2018, with a target for the first update being made by the second quarter of 2019.

Anatomical models are frequently made in a healthcare setting and their final use may differ from the initial intended use. For instance, a surgeon may determine that a model patient education may be useful for reference in the operating room during the surgical procedure. If the models enter the sterile field they would require sterilization and the effects of sterilization on the geometric fidelity of the model should be assessed. If they are to come into contact with the patient the effects of sterilization on the materials are especially important. While many standards and industry best practices exist, the healthcare facilities may not have relevant experience.

R&D Needed: No. Procedures and protocols for determining appropriate materials, sterilization cycles, and validation tests are already available but may not be implemented in healthcare settings.

Recommendation: Develop guides and best practices to help identify critical parameters and apply existing standards in a clinical setting.

Priority: Low

Organization: R&D: OEMs. Guidance: AAMI, AOAC International, ASTM, ISO, PDA, USP, RSNA 3DP SIG.

Status of Progress: Unknown

Update: The SME medical group is working on a biocompatibility worksheet for use with both models and surgical guides. This will not be a standard, but a guide of considerations.

Tissue engineered products present a particularly challenging circumstance for sterility assurance. While using a validated aseptic processing protocol for tissue engineered products can maintain sterility, it is not always sufficient or practical. Risk management standards can help decrease the risks of contamination with best practices but not provide defined measures to ensure the sterility or assess contamination in a tissue engineered product.

R&D Needed: Maybe. A wide variety of aseptic processing and sterilization protocols exist for tissue engineered products, however no standards have been published to address validation and testing of these protocols in tissue engineered products.

Recommendation: Develop and validate standard methods of sterilizing and verifying the sterility of tissue engineered products, especially those that can be applied in healthcare settings.

Priority: Medium

Organization: R&D: OEMs, FDA, BioFabUSA. Standards: AAMI, ISO, ASTM, AATB.

Status of Progress: New

Update: