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ISO 10993-7:2026 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

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ISO/ASTM 52938-1:2025

ISO/ASTM 52938-1:2025 Additive manufacturing of metals — Environment, health and safety — Part 1: Safety requirements for PBF-LB machines

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This publication was last reviewed and confirmed in 2025.

Additive manufacturing of metals — Environment, health and safety — Part 1: Safety requirements for PBF-LB machines

Description

This document deals with the technical requirements and the means for their verification for additive manufacturing (AM) machines using a bed of metallic powder, pyrophoric feedstock excluded, and a laser herein designated as machine.

This document deals with all significant hazards, hazardous situations or hazardous events during all phases of the life of the machine (ISO 12100:2010, 5.4), as listed in Annex A, caused by AM machines using a bed of metallic powder and a laser when used as intended and under conditions of misuse which are reasonably foreseeable by the manufacturer.

This document does not deal with hazards which can occur:

     during the design and construction phase of the laser beam powder ped fusion (PBF-LB) machine itself;

     operating in potentially explosive atmospheres.

This document does not apply to technologies other than AM metals PBF-LB.

This document is not applicable to machines manufactured before the date of its publication.

Edition

1

Published Date

2026-06-19

Status

PUBLISHED

Pages

30

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

This document deals with the technical requirements and the means for their verification for additive manufacturing (AM) machines using a bed of metallic powder, pyrophoric feedstock excluded, and a laser herein designated as machine.

This document deals with all significant hazards, hazardous situations or hazardous events during all phases of the life of the machine (ISO 12100:2010, 5.4), as listed in Annex A, caused by AM machines using a bed of metallic powder and a laser when used as intended and under conditions of misuse which are reasonably foreseeable by the manufacturer.

This document does not deal with hazards which can occur:

     during the design and construction phase of the laser beam powder ped fusion (PBF-LB) machine itself;

     operating in potentially explosive atmospheres.

This document does not apply to technologies other than AM metals PBF-LB.

This document is not applicable to machines manufactured before the date of its publication.

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