ISO 14971:2007 Preview

Medical devices -- Application of risk management to medical devices

This standard was last reviewed and confirmed in 2010. Therefore this version remains current.

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.

General information ^

Status : Published

Publication date : 2007-03
Corrected version (en) : 2007-09
Corrected version (fr) : 2007-09
Edition : 2

Number of pages : 82
Technical Committee
:
ISO/TC 210

Quality management and corresponding general aspects for medical devices
ICS :

11.040.01

Medical equipment in general

Buy this standard

	Format	Language
std 1 198	PDF + ePub
std 2 198	Paper
std 3 198	PDF

CHF198

Life cycle

A standard is reviewed every 5 years

Revisions / Corrigenda

Previously
ISO 14971:2000
ISO 14971:2000/Amd 1:2003
Now under review
ISO 14971:2007
Will be replaced by
ISO/FDIS 14971
ISO/DTR 24971

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