UNI EN 928 : 1997
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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
14-10-2015
01-01-1997
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
Fornisce una guida per l'applicazione delle EN 29001 ed EN 46001 e delle EN 29002 ed EN 46002 ai fornitori di dispositivi medici in vitro. Ha lo scopo di permettere una migliore comprensione delle norme stesse e di assistere sia nella loro applicazione, sia nella realizzazione e/o nella valutazione del sistema qualità.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Withdrawn
|
| Standards | Relationship |
| SN EN 928 : 1996 | Identical |
| NF EN 928 : 1996 | Identical |
| NS EN 928 : 1ED 1995 | Identical |
| NBN EN 928 : 1996 | Identical |
| NEN EN 928 : 1995 | Identical |
| UNE-EN 928:1996 | Identical |
| BS EN 928:1996 | Identical |
| I.S. EN 928:1996 | Identical |
| EN 928 : 1995 | Identical |
| DIN EN 928:1995-12 | Identical |
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