1.1 This guide provides guidance for assessing the manufacturing material residues in medical devices fabricated using additive manufacturing (AM) techniques, specifically, from powder bed fusion AM technologies. 1.1.1 Some of the techniques discussed in this guide may be applicable to devices fabricated by other types of AM equipment (for example, stereolithography). Given each AM techniques characteristics and post-processing challenges, there could be additional risks or considerations associated with some AM techniques or materials that are not addressed by this guide. 1.2 This guide covers several qualitative and quantitative assessments of the presence and amount of residue remaining in or obtained by extraction in aqueous or organic solvents from powder bed fusion AM medical components. 1.2.1 This guide identifies techniques to determine qualitatively the presence of residue and a technique to assess it quantitatively. It does not set acceptance criteria or acceptable limits for residues remaining in built parts. These methods are not the only methods to determine the presence or quantity of residual material in additive manufactured medical components. 1.3 This guide pertains to devices in their finished state, after post-processing and subsequent manufacturing processes, as applicable. This guide may also be used to evaluate the effectiveness of cleaning processes between critical steps in the manufacturing process to ensure minimal AM residue remains to be dealt with by cleaning processes downstream. 1.4 This guide is not intended to evaluate the residue level in medical components that have been cleaned for reuse. 1.5 Different cleaning methods, including high-energy processes, can potentially damage small structures in AM parts. This guide does not address measurement or mitigation of this risk. 1.6 This guide does not address the manufacturing occupational health issues of working with small particles, for example, breathing hazards. 1.7 Units--The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Keywordsdevice cleanliness; laser sintering; e-beam sintering; residual particles
Medical devices fabricated using powder bed fusion technology present a unique challenge in cleaning and cleanliness assessment and there are no existing standards addressing this. The proposed standard would be used by medical device manufacturers for process development or quality monitoring or both and would provide a consistent method for device cleanliness assessment by regulatory bodies.
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
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