ISO 14971:2007
Withdrawn
View Superseded by
Medical devices — Application of risk management to medical devices
Hardcopy , PDF
English, French, Russian
02-28-2007
04-09-2025
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.
| Committee |
ISO/TC 210
|
| DevelopmentNote |
Supersedes ISO 14971-1. (12/2000) DRAFT ISO/DIS 14971 is also available for this standard. (06/2018)
|
| DocumentType |
Standard
|
| Pages |
82
|
| ProductNote |
THIS STANDARD ALSO HAVE CORRECT VERSION FOR ENGLISH & FRENCH FOR THE YEAR 2007
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| CEI UNI EN ISO 14971 : 2013 | Identical |
| PN EN ISO 14971 : 2012 | Identical |
| NS EN ISO 14971 : 2012 | Identical |
| NEN EN ISO 14971 : 2007 + COR 2012 | Identical |
| BS EN ISO 14971:2012 | Identical |
| NBN EN ISO 14971 : 2012 | Identical |
| GOST ISO 14971 : 2011 | Identical |
| SS-EN ISO 14971 : 2012 | Identical |
| DIN EN ISO 14971:2013-04 | Identical |
| EN ISO 14971:2012 | Identical |
| I.S. EN ISO 14971:2012 | Identical |
| NF EN ISO 14971 : 2013 | Identical |
| NBR ISO 14971 : 2009 | Identical |
| BS EN ISO 14971:2007 | Equivalent |
| DIN EN ISO 14971:2007-07 | Equivalent |
| I.S. EN ISO 14971:2007 | Equivalent |
| BS EN ISO 14971:2009 | Identical |
| GOST R ISO 14971 : 2009 | Identical |
| UNE-EN ISO 14971:2012 | Identical |
| UNE-EN ISO 14971:2007 | Identical |
| JIS T 14971:2012 | Identical |
| NF EN ISO 14971 : 2009-11 | Identical |
| AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 | Identical |
| UNE-EN ISO 14971:2009 | Identical |
| AAMI ISO 14971 : 2007 : R2010 | Identical |
| BS EN ISO 14971:2007 | Identical |
A newer version of this standard is available.
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