SR EN ISO 14971:2003

Medical devices – Application of risk management to medical devices

Standardul specifica o procedura prin care un producator poate identifica riscurile asociate dispozitivelor medicale si componentelor acestora, inclusiv dispozitivele medicale de diagnostic in vitro, estimarea, evaluarea si controlul acestor riscurilor si monitorizarea eficientei controlului

General information

Status : Withdrawn
Approval date : 10/14/2003
Publish date : 10/15/2003
Withdrawal date : 8/31/2007
Number of pages : 40
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 EN ISO 14971:2003/AC:2003
Amended by SR EN ISO 14971:2003/A1:2003
A99 SR ISO 14971:2002/A99:2003