ISO/DIS 5092
Тезис
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.
Общая информация
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Текущий статус: В стадии разработкиЭтап: Рассылка краткого отчета по итогам голосования [40.60]
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Версия: 1
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Технический комитет :ISO/TC 150
- RSS обновления
Жизненный цикл
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Сейчас
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00
Предварительная стадия
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10
Стадия, связанная с внесением предложения
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20
Подготовительная стадия
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30
Стадия, связанная с подготовкой проекта комитета
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40
Стадия, связанная с рассмотрением проекта международного стандарта
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50
Стадия, на которой осуществляется принятие стандарта
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60
Стадия, на которой осуществляется публикация
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90
Стадия пересмотра
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95
Стадия, на которой осуществляется отмена стандарта
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00
