EN 928 : 1995
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
08-06-2005
02-11-1995
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
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| UNI EN 928 : 1997 | Identical |
| BS EN 928:1996 | Identical |
| SN EN 928 : 1996 | Identical |
| NF EN 928 : 1996 | Identical |
| NBN EN 928 : 1996 | Identical |
| NEN EN 928 : 1995 | Identical |
| UNE-EN 928:1996 | Identical |
| I.S. EN 928:1996 | Identical |
| NS EN 928 : 1ED 1995 | Identical |
| DIN EN 928:1995-12 | Identical |
| EN 46001 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001 |
| CEN ISO/TR 14969:2005 | Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004) |
| BS EN 46001:1997 | Specification for application of EN ISO 9001 to the manufacture of medical devices |
| AAMI ISO TIR 14969 : 2004 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| CSA ISO TR 14969 : 2005 : R2010 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| BS PD ISO/TR 14969 : 2004 AMD 15958 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| 03/314215 DC : DRAFT OCT 2003 | ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| CSA ISO TR 14969 : 2005 : R2015 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| CSA ISO TR 14969 :2005 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| ISO/TR 14969:2004 | Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
| BS EN 13612:2002 | Performance evaluation of in vitro diagnostic medical devices |
| I.S. CEN ISO TR 14969:2005 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003 |
| PD CEN ISO/TR 14969:2005 | Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003 |
| EN 29002 : 1994 | QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN PRODUCTION & INSTALLATION |
| EN 46001 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001 |
| EN 29004 : 1987 | QUALITY MANAGEMENT & QUALITY SYSTEM ELEMENTS - GUIDELINES |
| EN 46002 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002 |
| EN 29001 : 1994 | QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION & SERVICING |
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