BS EN 50103:1996
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
05-08-2008
English
15-03-1996
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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 |
CH/210/1
|
| DevelopmentNote |
Supersedes 92/52897 DC. (09/2005)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| NEN EN 50103 : 1995 | Identical |
| EN 50103 : 1995 | Identical |
| 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 |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| BS EN ISO 9001:2015 | Quality management systems. Requirements |
| EN 540 : 1993 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS |
| EN 724 : 1994 | GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES |
| BS EN 46002:1997 | Specification for application of EN ISO 9002 to the manufacture of medical devices |
| ISO 8402:1994 | Quality management and quality assurance — Vocabulary |
| ISO 9000-2:1997 | Quality management and quality assurance standards — Part 2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003 |
| EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
| ISO 9004:2009 | Managing for the sustained success of an organization A quality management approach |
| EN 29004-2:1993/AC:1997 | QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS - GUIDELINES FOR SERVICES |
| EN 29000-3 : 1993 | QUALITY MANAGEMENT AND QUALITY ASSURANCE STANDARDS - GUIDELINES FOR THE APPLICATION OF ISO 9001 TO THE DEVELOPMENT, SUPPLY AND MAINTENANCE OF SOFTWARE |
| BS EN ISO 9002:1994 | Quality systems. Model for quality assurance in production, installation and servicing |
| BS EN 46001:1997 | Specification for application of EN ISO 9001 to the manufacture of medical devices |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
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