EN 50103 : 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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY
01-02-2008
12-01-2013
Foreword
Introduction
1. Scope
2. Normative references
3. Terminology and definitions
3.1 Terminology
3.2 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 non-conforming 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
Annexes
A. (informative) Terminology - Index of terms
B. (informative) Bibliography
Contains guidelines for suppliers of active medical devices (including active implantable medical devices) who wish to ensure that they comply with EN 46001.
| Committee |
TC 62
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Withdrawn
|
| Standards | Relationship |
| UNE-EN 50103:1997 | Identical |
| NBN EN 50103 : 2000 | Identical |
| NF EN 50103 : 2003 | Identical |
| SN EN 50103 : 1995 | Identical |
| DIN EN 50103:1997-04 | Identical |
| I.S. EN 50103:1995 | Identical |
| BS EN 50103:1996 | Identical |
| NEN EN 50103 : 1995 | Identical |
| PN EN 50103 : 2002 | Identical |
| AS EN 50103-2002 | Identical |
| CEI EN 50103 : 1996 | 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) |
| CR 12401 : 1996 | DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES |
| CEI UNI EN 46003 : 2001 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9003 |
| 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 |
| ISO/TR 14969:2004 | 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 |
| BS EN 46003:1999 | Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003 |
| 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 |
| BS EN 550:1994 | Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization |
| 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 |
| PD CR 12401:2003 | Dentistry. Guidance on the classification of dental devices and accessories |
| ISO 8402:1994 | Quality management and quality assurance — Vocabulary |
| ISO 9002:1994 | Quality systems — Model for quality assurance in production, installation and servicing |
| ISO 9001:2015 | Quality management systems — Requirements |
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