DIN EN 46001:1996-09
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
01-02-2001
English
01-01-1996
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.
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| I.S. EN 46001:1997 | Identical |
| SN EN 46001 : 1997 | Identical |
| NBN EN 46001 : 1996 | Identical |
| NF EN 46001 : 1996 | Identical |
| NEN EN 46001 : 1996 | Identical |
| EN 46001 : 1996 | Identical |
| UNE-EN 46001:1996 | Identical |
| BS EN 46001:1997 | Identical |
| DIN 58946-6:2002-04 | STERILIZATION - STEAM STERILIZERS - PART 6: OPERATING OF LARGE STERILIZERS IN HEALTH CARE FACILITIES |
| DIN EN ISO 9001:2015-11 | QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015) |
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