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CSA PLUS 14971-07
The ISO 14971:2007 essentials — A practical handbook for implementing the ISO 14971 Standard for medical devices - Second Edition
Organization:
CSA - CSA Group
Year: 2007
Abstract: This International Standard 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 this International Standard are applicable to all stages of the life-cycle of a medical device.
This International Standard does not apply to clinical decision making.
This International Standard does not specify acceptable risk levels.
This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.
The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device.
This International Standard does not apply to clinical decision making.
This International Standard does not specify acceptable risk levels.
This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.
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CSA PLUS 14971-07
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| contributor author | CSA - CSA Group | |
| date accessioned | 2017-09-04T18:47:52Z | |
| date available | 2017-09-04T18:47:52Z | |
| date copyright | 2007.11.01 | |
| date issued | 2007 | |
| identifier other | KNGQBCAAAAAAAAAA.pdf | |
| identifier uri | http://yse.yabesh.ir/std;query=autho47037D83FCDCAC426159DD6E273C9FCD/handle/yse/229112 | |
| description abstract | This International Standard 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 this International Standard are applicable to all stages of the life-cycle of a medical device. This International Standard does not apply to clinical decision making. This International Standard does not specify acceptable risk levels. This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system. | |
| language | English | |
| title | CSA PLUS 14971-07 | num |
| title | The ISO 14971:2007 essentials — A practical handbook for implementing the ISO 14971 Standard for medical devices - Second Edition | en |
| type | standard | |
| page | 62 | |
| status | Active | |
| tree | CSA - CSA Group:;2007 | |
| contenttype | fulltext |