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SSH EN ISO 14971:2012

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

Apr 26, 2013
95.99 Withdrawal of Standard   Dec 11, 2020

General information

95.99     Dec 11, 2020

DPS

DPS/KT 316

European Norm

11.040.01  

English  

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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.

Related directives

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized
90/385/EEC

Active implantable medical devices

Harmonized
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 14971:2009

NOW

WITHDRAWN
SSH EN ISO 14971:2012
95.99 Withdrawal of Standard
Dec 11, 2020

REVISED BY

PUBLISHED
SSH EN ISO 14971:2019

Related project

Adopted from EN ISO 14971:2012