JIS Q 14971-1:2001
Withdrawn
Medical devices -- Risk management -- Part 1: Application of risk analysis
English
02-28-2001
05-25-2021
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Withdrawn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]
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.