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NF EN 928 : 1996

Withdrawn

Withdrawn

IN VITRO DIAGNOSTIC SYSTEMS - GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES

Published date

01-12-2013

Withdrawn date

07-05-2007

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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

DevelopmentNote
INDICE DE CLASSEMENT: S92031
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Withdrawn

Standards Relationship
DIN EN 928:1995-12 Identical
EN 928 : 1995 Identical
I.S. EN 928:1996 Identical
UNE-EN 928:1996 Identical
BS EN 928:1996 Identical

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