I.S. EN 50103:1995
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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
Hardcopy , PDF
09-06-2016
English
12-12-1995
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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
Applicable to a quality system as specified by EN 29001 and EN 46001 or EN 29002 and EN 46002. Provide concepts and objectives which should be considered by a supplier of active medical devices while developing and maintaining his quality system.
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| Standards | Relationship |
| NEN EN 50103 : 1995 | Identical |
| NF EN 50103 : 2003 | Identical |
| SN EN 50103 : 1995 | Identical |
| EN 50103 : 1995 | Identical |
| DIN EN 50103:1997-04 | Identical |
| UNE-EN 50103:1997 | Identical |
| BS EN 50103:1996 | Identical |
| NBN EN 50103 : 2000 | Identical |
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