BS EN 928:1996
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 in vitro diagnostic medical devices
Hardcopy , PDF
09-28-2007
English
06-15-1996
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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Withdrawn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 |
| 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 |
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.