CEI UNI EN 46003 : 2001
Withdrawn
QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9003
Hardcopy , PDF
Italian
01-01-2001
07-01-2020
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Withdrawn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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