Customer Service:
Mon - Fri: 8:30 am - 6 pm EST
Back
Standards PDF Cover Page

 Historical

SS-EN ISO 14971:2012

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) (Swedish Standard)

ISO 14971:2007 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.he requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

Available for Subscriptions

Content Provider
Swedish Standards Institute [sis]

Others Also Bought

SS-EN ISO 13485:2012
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) (Swedish ...
Add to cart
DIN EN ISO 18113-2:2013
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic ...
Add to cart
SS-EN 13641:2002
Elimination or reduction of risk of infection related to in vitro diagnostic reagents (Swedish Standard)
Add to cart
Document History
Revises:
Revised By:
Included in Packages
This standard is not included in any packages.
Amendments & Corrections
We have no amendments or corrections for this standard.
ANSI Logo

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

Useful Links
CUSTOMER SERVICE
NEW YORK OFFICE
ANSI HEADQUARTERS
2024 © American National Standards Institute (ANSI) All Rights Reserved.