SN EN 928 : 1996
Current
The latest, up-to-date edition.
IN VITRO DIAGNOSTIC SYSTEMS - GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Guidance on quality system requirements
4.1 Management responsibility
4.2 Quality system
4.3 Contract review
4.4 Design control
4.5 Document control
4.6 Purchasing
4.7 Purchaser supplied product
4.8 Product identification and traceability
4.9 Process control
4.10 Inspection and testing
4.11 Inspection, measuring and test equipment
4.12 Inspection and test status
4.13 Control of nonconforming product
4.14 Corrective action
4.15 Handling, storage, packaging and delivery
4.16 Quality records
4.17 Internal quality audits
4.18 Training
4.19 Servicing
4.20 Statistical techniques
Annex A (informative) Bibliography
Dieses Dokument ist erstellt worden als Leitfaden für die Organisationen, die Medizinprodukte für die In-vitro-Diagnose anbieten und den Wunsch haben, den Normen EN 29001/EN 29002 und den spezifischen Anforderungen EN 46001/EN 46002 zu entsprechen.
| Committee |
INB/NK 157
|
| DocumentType |
Standard
|
| PublisherName |
Swiss Standards
|
| Status |
Current
|
| Standards | Relationship |
| UNI EN 928 : 1997 | Identical |
| DIN EN 928:1995-12 | Identical |
| UNE-EN 928:1996 | Identical |
| EN 928 : 1995 | Identical |
| I.S. EN 928:1996 | Identical |
| BS EN 928:1996 | Identical |
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