EN 46001 : 1996
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 9001
12-01-2013
25-10-2000
Foreword
0 Introduction
1 Scope
2 Normative references
3 Definitions
4 Quality system requirements
4.1 Management responsibility
4.2 Quality system
4.3 Contract review
4.4 Design control
4.5 Document and data control
4.6 Purchasing
4.7 Control of customer-supplied product
4.8 Product identification and traceability
4.9 Process control
4.10 Inspection and testing
4.11 Control of inspection, measuring and test equipment
4.12 Inspection and test status
4.13 Control of nonconforming product
4.14 Corrective and preventive action
4.15 Handling, storage, packaging, preservation and delivery
4.16 Control of quality records
4.17 Internal quality audits
4.18 Training
4.19 Servicing
4.20 Statistical techniques
Annex A (informative) - Bibliography
Specifies the quality system requirements for the design/development, production, and where relevant, installation and servicing of medical devices.
| Committee |
TC 205, TC 62 & ýTC 140
|
| DevelopmentNote |
To be read in conjunction with EN ISO 9001. (07/2003) Supersedes ENV 50076. (08/2005)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| CEI EN 46001 : 2ED 1996 | Identical |
| NBN EN 46001 : 1996 | Identical |
| NEN EN 46001 : 1996 | Identical |
| BS EN 46001:1997 | Identical |
| I.S. EN 46001:1997 | Identical |
| NF EN 46001 : 1996 | Identical |
| DIN EN 46001:1996-09 | Identical |
| UNE-EN 46001:1996 | Identical |