ISO/DIS 5092

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Текущий статус : В стадии разработки

	Формат	Язык
std 1 63	PDF
std 2 63	Бумажный

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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.

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Общая информация

Текущий статус
: В стадии разработки

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

Этап
: Начало голосования по проекту между-народно-го стандарта: 3 мес. [40.20]
Версия
: 1
Технический комитет :
ISO/TC 150

ICS :
25.030 11.040.40
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