SR EN ISO 14155-1:2003

Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)

Standardul stabileste procedurile pentru conducerea si performanta investigatiilor clinice ale dispozitivelor medicale pentru a îndeplini aspectele tehnice ale diferitelor cerinte de reglementare nationale, regionale si internationale

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General information

Status : Withdrawn
Approval date : 10/14/2003
Publish date : 10/15/2003
Withdrawal date : 2/28/2010
Number of pages : 28
ICS : 11.100.20 Biological evaluation of medical devices
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN 540:1996
Replaced by SR EN ISO 14155-1:2009