SR EN ISO 13488:2002

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (revision of EN 46002:1996) (identical to ISO 13488:1996)

Standardul stabileste, împreuna cu ISO 9002, cerinte ale sistemului calitatii pentru productie si unde este relevant montaj si service al dispozitivelor medicale. Standardul este aplicabil atunci când exista o cerinta de evaluare a sistemelor calitatii furnizorului de dispozitive medicale

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General information

Status : Withdrawn
Approval date : 9/26/2002
Publish date : 9/27/2002
Withdrawal date : 7/31/2006
Number of pages : 20
ICS : 03.120.10 Quality management and quality assurance,11.040.01 Medical equipmet in general
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN 46002:2000
Replaced by SR EN ISO 13485:2004