SR EN ISO 14971:2007

Medical devices - Application of risk management to medical devices (ISO 14971:2007)

Acest standard stabileşte o procedură prin care un producător poate identifica pericolele asociate cu dispozitivele medicale, inclusiv dispozitivele medicale de diagnostic in vitro, să estimeze, şi evalueze riscurile, să controleze aceste riscuri şi să monitorizeze eficacitatea controalelor.

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General information

Status : Withdrawn
Approval date : 8/31/2007
Publish date : 9/2/2007
Withdrawal date : 2/28/2010
Number of pages : 88
ICS : 11.040.01 Medical equipmet in general
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR ISO 14971:2002/A99:2003
Replaces SR ISO 14971:2002
Replaces SR EN ISO 14971:2003/AC:2003
Replaces SR EN ISO 14971:2003/A1:2003
Replaces SR EN ISO 14971:2003
Normative reference SR EN ISO 9000:2006
Normative reference SR EN ISO 13485:2004
Replaced by SR EN ISO 14971:2009