• There are no items in your cart

EN 928 : 1995

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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
Withdrawn date

06-08-2005

Published date

11-02-1995

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

DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn

Standards Relationship
UNI EN 928 : 1997 Identical
BS EN 928:1996 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
NS EN 928 : 1ED 1995 Identical
DIN EN 928:1995-12 Identical

EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
BS EN 46001:1997 Specification for application of EN ISO 9001 to the manufacture of medical devices
AAMI ISO TIR 14969 : 2004 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
CSA ISO TR 14969 : 2005 : R2010 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
BS PD ISO/TR 14969 : 2004 AMD 15958 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
03/314215 DC : DRAFT OCT 2003 ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
CSA ISO TR 14969 : 2005 : R2015 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
CSA ISO TR 14969 :2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
BS EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
EN 13612:2002/AC:2002 PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
I.S. CEN ISO TR 14969:2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003
PD CEN ISO/TR 14969:2005 Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003

EN 29002 : 1994 QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN PRODUCTION & INSTALLATION
EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
EN 29004 : 1987 QUALITY MANAGEMENT & QUALITY SYSTEM ELEMENTS - GUIDELINES
EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
EN 29001 : 1994 QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION & SERVICING

View more information
Sorry this product is not available in your region.

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.