ISO 14971:2007

Medical devices — Application of risk management to medical devices

Publication date: 28 shk 2007

95.99 Withdrawal of Standard 10 dhj 2019

General information

Current stage: 95.99 Effective date: 10 dhj 2019

Originator: ISO

Owner: ISO/TC 210

Type: International Standard

ICS: 11.040.01

Gjuha: anglisht frëngjisht

Buying

Statusi: Shfuqizuar

PDF - 7 576 Lekë

Paper - 7 576 Lekë

CD - 7 576 Lekë

Language

Language in which you want to receive the document.

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 14971:2000

WITHDRAWN
ISO 14971:2000/Amd 1:2003

NOW

WITHDRAWN
ISO 14971:2007
95.99 Withdrawal of Standard
10 dhj 2019

REVISED BY

PUBLISHED
ISO 14971:2019