SR ISO 14971:2002

Medical devices. Application of risk management to medical devices

Prezentul standard stabileste o procedura prin care un producator poate identifica pericolele asociate cu dispozitivele medicale si accesorile acestora, inclusiv dispozitivele medicale de diagnostic in vitro, estima si evalua riscurile , controla aceste riscuri si monitoriza eficienta controlului.

General information

Status : Withdrawn
Approval date : 10/31/2002
Publish date : 12/15/2003
Withdrawal date : 8/31/2007
Number of pages : 38
ICS : 11.040.01 Medical equipmet in general
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaced by SR EN ISO 14971:2007
Amended by SR ISO 14971:2002/A99:2003