NBN EN 46002 : 1996
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
KWALITEITSSYSTEMEN - MEDISCHE APPARATUUR - BIJZONDERE EISEN VOOR DE TOEPASSING VAN EN 29002
01-02-2001
12-01-2013
Cooperating organizations
National foreword
Foreword
0. Introduction
1. Scope and field of application
2. Normative references
3. Definitions
4. Quality system requirements
4.1 Management responsibility
4.2 Quality system
4.3 Contract review
4.4 Document control
4.5 Purchasing
4.6 Purchaser supplied product
4.7 Product identification and traceability
4.8 Process control
4.9 Inspection and testing
4.10 Inspection, measuring and test equipment
4.11 Inspection and test status
4.12 Control of nonconforming product
4.13 Corrective action
4.14 Handling, storage, packaging and delivery
4.15 Quality records
4.16 Internal quality audits
4.17 Training
4.18 Statistical techniques
Annex A (informative) - Bibliography
National annex NA (informative) Committees responsible
National annex NB (informative) Cross-references
Specifies the quality requirements for the production and, where relevant, installation of medical devices. Coverage includes: quality system requirements; product identification and traceability; inspection, measuring and test equipment; control of nonconforming product; handling, storage, packaging and delivery; internal quality audits. Also gives detailed definitions.
| DocumentType |
Standard
|
| PublisherName |
Belgian Standards
|
| Status |
Superseded
|
| Standards | Relationship |
| BS EN 46002:1997 | Identical |
| I.S. EN 46002:1997 | Identical |
| DIN EN 46002:1996-09 | Identical |
| EN 46002 : 1996 | Identical |
| UNE-EN 46002:1996 | Identical |
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