JIS T 14971:2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical devices -- Application of risk management to medical devices
English
01-03-2012
19-11-2020
This Japanese Industrial Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic medical devices to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this Standard are applicable to all stages of the life-cycle of a medical device.
| DocumentType |
Standard
|
| Pages |
94
|
| ProductNote |
Japanese PDF version unavailable from Intertek Inform.
|
| PublisherName |
Japanese Standards Association
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 14971:2007 | Identical |
Reaffirmed 2016 2012(R2016) [25/10/2016]2012 [01/03/2012]2003(R2009) [25/04/2009]2003 [25/08/2003]
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