May 02, 2013 Abstract ISO 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.
ISO 14971:2000General information
- Publication date : 2000-12
- Number of pages : 32
- :Quality management and corresponding general aspects for medical devices
- ICS :
- Medical equipment in general
Life cycle
A standard is reviewed every 5 years
- 10Proposal
- 30
- 40Enquiry
- 50
- 60Publication
- 90
- 95.99
Revisions / Corrigenda
- Previously
ISO 14971-1:1998 - Now withdrawn
ISO 14971:2000 - Corrigenda/Amendments
ISO 14971:2000/Amd 1:2003 - Revised by
ISO 14971:2007
+41 22 749 08 88
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)
Keep up to date with ISO
Sign up to our newsletter for the latest news, views and product information
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012 (Foreign Standard)
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.
Content Provider
Deutsches Institut für Normung [DIN]
Please first log in with a verified email before subscribing to alerts. Deutsches Institut für Normung [DIN]
Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email. You may delete a document from your Alert Profile at any time. To add a document to your Profile Alert, search for the document and click “alert me”.
Please first verify your email before subscribing to alerts. Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email. You may delete a document from your Alert Profile at any time. To add a document to your Profile Alert, search for the document and click “alert me”.
Already Subscribed to this document. Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email. You may delete a document from your Alert Profile at any time. To add a document to your Profile Alert, search for the document and click “alert me”.
Documents sold on the ANSI Webstore are in electronic Adobe Acrobat PDF format, however some ISO and IEC standards are available from Amazon in hard copy format.
Some PDF files are protected by Digital Rights Management (DRM) at the request of the copyright holder. You can download and open this file to your own computer but DRM prevents opening this file on another computer, including a networked server. Some copyright holders may impose other restrictions that limit document printing and copy/paste of documents.
![Iso 14971 Standard Iso 14971 Standard](http://gostrf.com/gostdata/530/53011/12.gif)
Those documents cannot be printed at the request of the copyright holder.