Standard

SN EN ISO 14971:2012

Sep 2012 Withdrawn

Note: Latest version: SN EN ISO 14971:2020

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Abstract

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.

Products specifications

Standard from INB
Published: September 1 2012
Withdrawn: February 1 2020
Effective: September 1 2012
Document type: EN
Pages
ISBN:

ICS: 11.040.01
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 410

Swiss Federal Authority: SWISSMEDIC
Designated under following Swiss law: 812.213
Designated under following EU law: 90/385/EWG, Council Directive 93/42/EEC

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Replaced by: SN EN ISO 14971:2020
Replaces: SN EN ISO 14971:2010
Adopted from: ISO 14971:2007, IDT

SN EN ISO 14971:2012

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SN EN ISO 14971:2020