Standard Swedish standard · SS-EN ISO 14971:2012

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

Status: Withdrawn

· Replaced by: SS-EN ISO 14971:2020 , SS-EN ISO 14971:2020
Scope
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.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

Subjects

General (11.040.01) Quality management and corresponding general aspects for medical devices (11.110.10)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-87165

Edition: 4

Approved: 8/14/2012

No of pages: 104

Replaces: SS-EN ISO 14971:2009

Replaced by: SS-EN ISO 14971:2020 , SS-EN ISO 14971:2020