Uni Cei En Iso 14971 Medical Devices

 

View Riccardo Mazzolai’s profile on LinkedIn, the world's largest professional community. Riccardo has 1 job listed on their profile. See the complete profile on LinkedIn and discover Riccardo. FDA Medical Device Industry Coalition ISO 14971: Overview of the standard Risk Management Through Product Life Cycle: An Educational Forum William A. Hyman Department of Biomedical Engineering Texas A&M University April 2010 2 Medical devices – Application of risk management to medical devices - 14 pages in body - 63 pages in 10 Annexes.

Status: Valid

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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En Iso 14971

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

Subjects

IEC 62366-1:2015

Abstract Preview

IEC 62366-1:2015 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014). Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety-related aspects of medical device user interfaces.


General information

  • Publication date : 2015-02
  • Number of pages : 96
  • :
    Quality management and corresponding general aspects for medical devices
  • ICS :
    Medical equipment in general

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  • CHF270
14971

Life cycle

Uni Cei En Iso 14971 Medical Devices

A standard is reviewed every 5 years

  • 10
    Proposal
  • 30
  • 40
  • 50
  • 60.60
    Publication

Iso 14971 Pdf


Revisions / Corrigenda

  • Previously
    IEC 62366:2007
    IEC 62366:2007/Amd 1:2014
  • Now
    IEC 62366-1:2015
  • Corrigenda/Amendments
    IEC 62366-1:2015/Cor 1:2016
    IEC 62366-1:2015/DAmd 1

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Iso 14971

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