http://iet.metastore.ingenta.com
1887

ISO 14971: medical devices - application of risk management to medical devices

ISO 14971: medical devices - application of risk management to medical devices

For access to this article, please select a purchase option:

Buy chapter PDF
£10.00
(plus tax if applicable)

IET members benefit from discounts to all IET publications and free access to E&T Magazine. If you are an IET member, log in to your account and the discounts will automatically be applied.

Learn more about IET membership 

Recommend Title Publication to library

You must fill out fields marked with: *

Librarian details
Name:*
Email:*
Your details
Name:*
Email:*
Department:*
Why are you recommending this title?
Select reason:
 
 
 
 
 
Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification — Recommend this title to your library

Thank you

Your recommendation has been sent to your librarian.

The paper discussed the ISO 14971 standards. ISO 14971 is an international standard for risk management specifically devised for the development of medical devices. The standard is intended to help manufacturers to establish a full risk-management process that includes the identification of hazards, the assessment of the related risks, and the implementation of risk control measures.

Chapter Contents:

  • 6.1 Introduction
  • 6.2 Contents
  • 6.3 Risk concepts applied to medical devices
  • 6.4 Examples of hazards, foreseeable sequences of events and hazardous situations
  • 6.5 Risk-management methods and tools
  • 6.5.1 Failure mode effects analysis
  • 6.5.2 Failure mode, effects, and criticality analysis
  • 6.5.3 Fault tree analysis
  • 6.5.4 Hazard analysis and critical control points
  • 6.5.5 Hazard operability (HAZOP) analysis
  • 6.5.6 Preliminary hazard analysis
  • 6.5.7 Markov analysis
  • 6.6 Use of ISO 14971: 2007 in each jurisdiction

Inspec keywords: risk management; biomedical equipment; ISO standards; hazards

Other keywords: medical devices; ISO 14971; risk assessment; hazard identification; full risk-management process; international standard; risk control measures

Subjects: Standards and calibration; Health and safety aspects; Management issues

Preview this chapter:
Zoom in
Zoomout

ISO 14971: medical devices - application of risk management to medical devices, Page 1 of 2

| /docserver/preview/fulltext/books/he/pbhe012e/PBHE012E_ch6-1.gif /docserver/preview/fulltext/books/he/pbhe012e/PBHE012E_ch6-2.gif

Related content

content/books/10.1049/pbhe012e_ch6
pub_keyword,iet_inspecKeyword,pub_concept
6
6
Loading
This is a required field
Please enter a valid email address