NF EN ISO 14971

NF EN ISO 14971

January 2009
Standard Cancelled

Medical devices — Application of risk management to medical devices

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Main informations

Collections

National standards and national normative documents

Publication date

January 2009

Number of pages

100 p.

Reference

NF EN ISO 14971

ICS Codes

11.040.01   Medical equipment in general

Print number

1 - 16/10/2009

International kinship

ISO 14971:2007

European kinship

EN ISO 14971:2009
Replaced standards (1)
NF EN ISO 14971
January 2007
Standard Cancelled
Medical devices — Application of risk management to medical devices

Standard replaced by (1)
NF EN ISO 14971
January 2013
Standard Cancelled
Medical devices - Application of risk management to medical devices

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.

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