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CEI UNI EN 46003 : 2001

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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

Available format(s)

Hardcopy , PDF

Withdrawn date

01-07-2020

Language(s)

Italian

Published date

01-01-2001

€30.43
Excluding VAT

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Withdrawn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

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