Reference number
ISO 16054:2019
© ISO 2024
International Standard
ISO 16054:2019
Implants for surgery — Minimum data sets for surgical implants
Edition 2
2019-07
Preview
недоступно на русском языке
Опубликовано (Версия 2, 2019)

ISO 16054:2019

Язык
Формат
CHF 42
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Тезис

This document defines minimum data sets for implants to facilitate recording and international exchange of data for the purposes of implant tracking systems. This data can also be used to support retrieval analysis and implant registry.

This document is applicable to the manufacturers and distributors of medical devices intended for implant via a surgical procedure and to those hospitals and other medical facilities which carry out implant or explant procedures. It specifies requirements for data items to be recorded by the manufacturers and distributors of implants and by hospitals and other medical facilities at both the time of implant event and at the time of any subsequent explant event.

This document is intended to define a minimum data set to be recorded for all implant and explant events, as well as providing for the timely retrieval of minimum implant data related to specific subsets of patients who have received specific identified devices or devices within a specified range of lot, batch or serial codes, for the purpose of patient follow up.

It is not the intent of this document to provide a means of data recovery which is related to specific medical practitioners, medical facilities or manufacturers for purposes other than patient follow up or product recall in the event of unforeseen device malfunction.

Общая информация

  • Текущий статус
     : Опубликовано
    Дата публикации
     : 2019-07
    Этап
    : Международный стандарт подлежит пересмотру [90.92]
  • Версия
     : 2
  • Технический комитет :
    ISO/TC 150
    ICS :
    11.040.40 
  • RSS обновления

Жизненный цикл

Цели в области устойчивого развития

Данный стандарт разработан для достижения следующих Цель устойчивого развития

3
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