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NEN EN ISO 14155 : 2011 C1 2011

Current

Current

The latest, up-to-date edition.

CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE

Published date

01-12-2013

Defines good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

DevelopmentNote
Supersedes NEN EN ISO 14155-1 and NEN EN ISO 14155-2. (02/2011) Corrigendum 1 was cancelled on 7 March, 2012. (09/2012)
DocumentType
Standard
PublisherName
Netherlands Standards
Status
Current

Standards Relationship
EN ISO 14155:2011/AC:2011 Identical
ISO 14155:2011 Identical

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