Draft International Standard
ISO/DIS 5092
Additive manufacturing for medical — General principles — Additive manufacturing of non-active implants
Reference number
ISO/DIS 5092
Edition 1
Draft
International Standard
Read sample
ISO/DIS 5092
80762
This Draft International Standard is in the enquiry phase with ISO members.

ISO/DIS 5092

ISO/DIS 5092
80762
Language
Format
CHF 63
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Abstract

This document identifies factors that affect the safety and performance of surgical implants due to the fact these implants are manufactured additively.

This document applies to non-active implants manufactured additively, including custom-made implants, and patient-matched implants.

This document also applies to instrumentation for use in association with non-active surgical implants manufactured by AM.

While this document is not intended to apply to active implants, parts of the document can potentially still be used in the context of active implants.

This document  identifies factors, which are either unique to additively manufactured implants or which require additional consideration for additively manufactured implants that might not be currently included within existing implant specific standards, which might have to be revised and updated.

This document does not apply to tissue-engineered implants manufactured by AM.

NOTE 1 This document provides references to existing or currently developed relevant documents in ISO/TC 150, ISO/TC 261, ASTM F04 and ASTM F42.

NOTE 2 Application of a quality management system, such as that described in ISO 13485, could be appropriate to help ensure that the implant achieves its intended performance.

General information

  •  : Under development

    You can help develop this draft international standard by contacting your national member

    : DIS ballot initiated: 12 weeks [40.20]
  •  : 1
     : 11
  • ISO/TC 150
    25.030  11.040.40 
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Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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