BS EN 928:1996

Withdrawn

Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices

Available format(s)

Hardcopy , PDF

Withdrawn date

28-09-2007

Language(s)

English

Published date

15-06-1996

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 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 nonconforming 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
Annex A (informative) Bibliography

Committee	CH/210/1
DevelopmentNote	Supersedes 92/58310 DC. (09/2005)
DocumentType	Standard
Pages	18
PublisherName	British Standards Institution
Status	Withdrawn
Supersedes	92/58310 DC : NOV 92 92/58610 DC : LATEST

Standards	Relationship
NS EN 928 : 1ED 1995	Identical
UNI EN 928 : 1997	Identical
SN EN 928 : 1996	Identical
NF EN 928 : 1996	Identical
NBN EN 928 : 1996	Identical
NEN EN 928 : 1995	Identical
UNE-EN 928:1996	Identical
I.S. EN 928:1996	Identical
EN 928 : 1995	Identical
DIN EN 928:1995-12	Identical

EN 550 : 1994	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
BS 5750-2:1987	Quality systems Specification for production and installation
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
BS 5750-0.2(1987) : 1987	QUALITY SYSTEMS - PRINCIPAL CONCEPTS AND APPLICATIONS - GUIDE TO QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS
EN 552:1994/A2:2000	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
BS 5750-1:1987	Quality systems Specification for design/development, 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