I.S. EN 46002:1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
Hardcopy , PDF
27-04-2001
English
01-01-1997
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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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 system requirements for the production, and where relevant, installation of medical devices.
| DevelopmentNote |
To be used in conjunction with I.S. EN ISO 9002. (02/2002)
|
| DocumentType |
Standard
|
| Pages |
21
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| DIN EN 46002:1996-09 | Identical |
| SN EN 46002 : 1997 | Identical |
| NF EN 46002 : 1996 | Identical |
| BS EN 46002:1997 | Identical |
| NBN EN 46002 : 1996 | Identical |
| EN 46002 : 1996 | Identical |
| NEN EN 46002 : 1996 | Identical |
| UNE-EN 46002:1996 | Identical |
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