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CEI EN 50103 : 1996

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Available format(s)

Hardcopy , PDF

Withdrawn date

07-01-2020

Language(s)

English - Italian

Published date

01-01-1996

Publisher

Comitato Elettrotecnico Italiano

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Withdrawn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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Hardcopy - English - Italian
PDF - English - Italian
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