I.S. EN 928:1996
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
08-06-2005
English
06-09-1996
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 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
Provides guidance on the implementation of EN 29001 and I.S. EN 46001 and of EN 29002 and I.S. EN 46002 as applied to the manufacturer of IVDs.
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| Standards | Relationship |
| SN EN 928 : 1996 | Identical |
| NF EN 928 : 1996 | Identical |
| NS EN 928 : 1ED 1995 | Identical |
| UNI EN 928 : 1997 | Identical |
| NBN EN 928 : 1996 | Identical |
| NEN EN 928 : 1995 | Identical |
| UNE-EN 928:1996 | Identical |
| BS EN 928:1996 | Identical |
| EN 928 : 1995 | Identical |
| DIN EN 928:1995-12 | Identical |
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