Draft International Standard
ISO/DIS 5092
Additive manufacturing for medical — General principles — Additive manufacturing of non-active implants
Reference number
ISO/DIS 5092
Edición 1
Draft
International Standard
Vista previa
ISO/DIS 5092
80762
No disponible en español
Este borrador de Norma Internacional se encuentra en la fase de consultas con los miembros de ISO.

ISO/DIS 5092

ISO/DIS 5092
80762
Idioma
Formato
CHF 63
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Resumen

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.

Informaciones generales

  •  : En desarrollo

    Puede contribuir al desarrollo del borrador de esta norma internacional. Para ello, contacte con su miembro nacional

    : Voto sobre el DIS iniciado: 12 semanas [40.20]
  •  : 1
     : 11
  • ISO/TC 150
    25.030  11.040.40 
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