JIS Q 14971-1:2001
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Medical devices -- Risk management -- Part 1: Application of risk analysis
English
28-02-2001
25-05-2021
This part of JIS Q 14971 specifies a procedure for investigating, using available information, the safety of a medical device, including in vitro diagnostic devices (IVD) or accessories, by identifying hazards and estimating the risks associated with the device. It may be or particular assistance in areas where relevant standards are not available or not used. This part of JIS Q 14971 does not stipulate levels of acceptability because these are determined by a multiplicity of factors that cannot be set down in such a standard. This part of JIS Q 14971 is not intended to give guidance on all aspects of management of risks. Furthermore, it is not intended to cover decision-marking processes regarding assessment of the indications and contra-indications for the use of a particular device.
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
Japanese Standards Association
|
| Status |
Withdrawn
|
| Standards | Relationship |
| ISO 14971-1:1998 | Identical |
Reaffirmed 2015 2001(R2015) [26/10/2015]2001(R2009) [25/04/2009]2001 [25/02/2001]
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