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SN EN 50103 : 1995

Current
Current

The latest, up-to-date edition.

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
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
Swiss 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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