CEI EN 50103 : 1996
Withdrawn
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
English - Italian
01-01-1996
07-01-2020
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Withdrawn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 9002:1994 | Quality systems — Model for quality assurance in production, installation and servicing |
| 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 |
| 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 |
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.