ASTM F3335-20 用粉末床熔合法制造的医疗器械中添加剂制造残留物的去除评定的标准指南.pdf

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standartis.Guides and Remendations issued by the World Trade Organization Technical Barriers to Trade (TBT)Committee. Designation:F3335-20 INTERNATIONAL Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion This standard is issued under the fixed designation F3335;the number immediately following the designation indicates the year of original adoption or in the case of revision the year of last revision.A number in parentheses indicates the year of last reapproval.A superseript epsilon (e)indicates an editorial change since the last revision or reapproval. 1.Scope 1.7 The values stated in SI units are to be regarded as 1.1 This standard provides guidance for assessing the manu- standard.No other units of measurement are included in this facturing material residues in medical devices fabricated using standard. additive manufacturing (AM)techniques specifically from 1.8 This standard does not purport to address all of the powder bed fusion AM technologies. safety concerns if any associated with its use.It is the 1.1.1 Some of the techniques discussed in this guide may be responsibility of the user of this standard to establish appro- applicable to devices fabricated by other types of AM equip- priate safety he...