Reference number
ISO/TR 14283:2018
© ISO 2024
Technical Report
ISO/TR 14283:2018
Implants for surgery — Essential principles of safety and performance
Edition 3
2018-01
Technical Report
Preview
недоступно на русском языке
Опубликовано (Версия 3, 2018)

ISO/TR 14283:2018

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CHF 129
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Тезис

ISO/TR 14283:2017 provides fundamental principles for the design and manufacture of active or non-active implants in order that each implant can achieve its intended purpose.

ISO/TR 14283:2017 is often the case that instruments and other equipment are used in association with implants. These devices might be useful or even essential for the safe implantation and/or use of the implants. This document applies to implants, however, it also applies to associated instruments and equipment to the extent that the design and manufacture of the implants is intended to ensure the safe combination and use of the implants with such devices.

Requirements for the safe operation and use of associated instruments and equipment are contained in other standards.

Общая информация

  • Текущий статус
     : Опубликовано
    Дата публикации
     : 2018-01
    Этап
    : Опубликование международного стандарта [60.60]
  • Версия
     : 3
  • Технический комитет :
    ISO/TC 150
    ICS :
    11.040.40 
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