درباره ما
ISO TR 24971
Medical devices - Guidance on the application of ISO 14971 - First Edition
Organization:
ISO - International Organization for Standardization
Year: 2013
Abstract: This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management.
The guidance is intended to assist manufacturers and other users of the standard to:
— understand the role of international product safety and process standards in risk management;
— develop the policy for determining the criteria for risk acceptability;
— incorporate production and post-production feedback loop into risk management;
— differentiate between "information for safety" and "disclosure of residual risk"; and
— evaluate overall residual risk.
The guidance is intended to assist manufacturers and other users of the standard to:
— understand the role of international product safety and process standards in risk management;
— develop the policy for determining the criteria for risk acceptability;
— incorporate production and post-production feedback loop into risk management;
— differentiate between "information for safety" and "disclosure of residual risk"; and
— evaluate overall residual risk.
Collections
:
Show full item record
| contributor author | ISO - International Organization for Standardization | |
| date accessioned | 2017-09-04T18:48:57Z | |
| date available | 2017-09-04T18:48:57Z | |
| date copyright | 2013.07.01 | |
| date issued | 2013 | |
| identifier other | KQKWDFAAAAAAAAAA.pdf | |
| identifier uri | http://yse.yabesh.ir/std;query=autho47037DAVY%20-%206159DD6E273C9FCD0Facili/handle/yse/230286 | |
| description abstract | This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management. The guidance is intended to assist manufacturers and other users of the standard to: — understand the role of international product safety and process standards in risk management; — develop the policy for determining the criteria for risk acceptability; — incorporate production and post-production feedback loop into risk management; — differentiate between "information for safety" and "disclosure of residual risk"; and — evaluate overall residual risk. | |
| language | English | |
| title | ISO TR 24971 | num |
| title | Medical devices - Guidance on the application of ISO 14971 - First Edition | en |
| type | standard | |
| page | 20 | |
| status | Active | |
| tree | ISO - International Organization for Standardization:;2013 | |
| contenttype | fulltext |