CEI 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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
01-07-2020
English - Italian
01-01-1996
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INTRODUCTION
1 SCOPE
2 NORMATIVE REFERENCES
3 TERMINOLOGY AND DEFINITIONS
4 GUIDANCE ON QUALITY SYSTEM REQUIREMENTS
ANNEX A informative - TERMINOLOGY - INDEX OF TERMS
ANNEX B informative - BIBLIOGRAPHY
Defines concepts and objectives which should be considered by a SUPPLIER of ACTIVE MEDICAL DEVICES while developing and maintaining his QUALITY SYSTEM.
| Committee |
CT 62
|
| DevelopmentNote |
Classificazione CEI 62-72 (09/2001)
|
| DocumentType |
Standard
|
| Pages |
38
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Withdrawn
|
| Standards | Relationship |
| EN 50103 : 1995 | Identical |
| EN 29002 : 1994 | QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN PRODUCTION & INSTALLATION |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| EN 46001 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001 |
| 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 |
| ISO 8402:1994 | Quality management and quality assurance — Vocabulary |
| ISO 9004-2:1991 | Quality management and quality system elements Part 2: Guidelines for services |
| 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 |
| ISO 9001:2015 | Quality management systems — Requirements |
| EN 46002 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002 |
| 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 |
| ISO 9003:1994 | Quality systems Model for quality assurance in final inspection and test |
| UNI EN 29001 : 1988 | |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| EN 29001 : 1994 | QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION & SERVICING |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
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