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BS 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Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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Withdrawn date

05-08-2008

Language(s)

English

Published date

15-03-1996

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Withdrawn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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