NBN EN 50103 : 2000
Current
The latest, up-to-date edition.
RICHTLINJEN VOOR DE TOEPASSING VAN EN 29001 EN EN 46001 EN VAN EN 29002 EN EN 46002 VOOR DE INDUSTRIE VAN ACTIEVE MEDISCHE PRODUKTEN (MET INBEGRIP VAN ACTIEVE IMPLANTATEN)
01-12-2013
Foreword
Introduction
1. Scope
2. Normative references
3. Terminology and definitions
3.1 Terminology
3.2 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 non-conforming 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
Annexes
A. (informative) Terminology - Index of terms
B. (informative) Bibliography
Contains guidelines for suppliers of active medical devices (including active implantable medical devices) who wish to ensure that they comply with EN 46001.
| DocumentType |
Standard
|
| PublisherName |
Belgian Standards
|
| Status |
Current
|
| Standards | Relationship |
| DIN EN 50103:1997-04 | Identical |
| UNE-EN 50103:1997 | Identical |
| I.S. EN 50103:1995 | Identical |
| BS EN 50103:1996 | Identical |
| EN 50103 : 1995 | Identical |
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