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SRPS EN ISO 14971:2014

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

Apr 30, 2014
Apr 30, 2014
95.99   Withdrawal of Standard   Jan 31, 2020

General information

95.99     Jan 31, 2020

ISS

Z076

European Norm

11.040.01  

Serbian  

From plan 2012/zbog nemogućnosti realizacije planira se za naredni period/za komisiju Medicinska sredstva

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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

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

90/385/EEC

Active implantable medical devices

Harmonized
Directive 90/385/EEC
93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
98/79/EC

In vitro diagnostic medical devices

Harmonized
Directive 98/79/EC
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

Directive 2007/47/EC

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 14971:2009

NOW

WITHDRAWN
SRPS EN ISO 14971:2014
95.99 Withdrawal of Standard
Jan 31, 2020

REVISED BY

PUBLISHED
SRPS EN ISO 14971:2020

Related project

Adopted from EN ISO 14971:2012

Adopted from ISO 14971:2007 IDENTICAL

National regulations and standards

"Сл. гласник РС" бр. 40/2019 40/2019
PRAVILNIK O KLINIČKOM ISPITIVANjU MEDICINSKOG SREDSTVA

MINISTARSTVO ZDRAVLjA