CEI UNI EN 46003 : 2001
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
07-01-2020
Italian
01-01-2001
Important note : All end users must be registered with an Account prior to user licenses being assigned.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Withdrawn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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