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NBN EN 50103 : 2000

Current
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)
Published date

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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