CEI UNI EN 46003 : 2001

Withdrawn

QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9003

Available format(s)

Hardcopy , PDF

Withdrawn date

07-01-2020

Language(s)

Italian

Published date

01-01-2001

Publisher

Comitato Elettrotecnico Italiano

FASC 6085 La norma specifica, le prescrizioni relative ai sistemi qualità per l'ispezione e la prova finale dei dispositivi medici, esclusi i dispositivi medici per la diagnostica in vitro e i dispositivi medici impiantabili, e puo essere applicata nel momento in cui il sistema qualità di un fornitore di dispositivi medici sia ritenuto conforme alle prescrizioni legislative.

Committee	CT 62
DevelopmentNote	Classificazione CEI 62-117 (07/2001)
DocumentType	Standard
Pages	16
PublisherName	Comitato Elettrotecnico Italiano
Status	Withdrawn

Standards	Relationship
EN 46003 : 1999	Identical

EN 46001 : 1996	QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
EN 724 : 1994	GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES
ISO 8402:1994	Quality management and quality assurance — Vocabulary
EN ISO 9003:1994/AC:1997	QUALITY SYSTEMS - SPECIFICATION FOR FINAL INSPECTION AND TEST
EN 50103 : 1995	GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY
EN 46002 : 1996	QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
ISO 9003:1994	Quality systems Model for quality assurance in final inspection and test
EN ISO 8402 : 1995	QUALITY MANAGEMENT AND QUALITY ASSURANCE - VOCABULARY