BS EN 46002:1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Specification for application of EN ISO 9002 to the manufacture of medical devices
Hardcopy , PDF
23-07-2013
English
15-02-1997
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Cooperating organizations
National foreword
Foreword
0. Introduction
1. Scope and field of application
2. Normative references
3. Definitions
4. Quality system requirements
4.1 Management responsibility
4.2 Quality system
4.3 Contract review
4.4 Document control
4.5 Purchasing
4.6 Purchaser supplied product
4.7 Product identification and traceability
4.8 Process control
4.9 Inspection and testing
4.10 Inspection, measuring and test equipment
4.11 Inspection and test status
4.12 Control of nonconforming product
4.13 Corrective action
4.14 Handling, storage, packaging and delivery
4.15 Quality records
4.16 Internal quality audits
4.17 Training
4.18 Statistical techniques
Annex A (informative) - Bibliography
National annex NA (informative) Committees responsible
National annex NB (informative) Cross-references
Specifies additional requirements for quality systems used in manufacture of medical devices.
| Committee |
CH/210/1
|
| DevelopmentNote |
DRAFT FOR COMMENT 91/58124 DC
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN 46002:1996-09 | Identical |
| SN EN 46002 : 1997 | Identical |
| NF EN 46002 : 1996 | Identical |
| NBN EN 46002 : 1996 | Identical |
| EN 46002 : 1996 | Identical |
| NEN EN 46002 : 1996 | Identical |
| I.S. EN 46002:1997 | Identical |
| UNE-EN 46002:1996 | Identical |
| BS EN 724:1995 | Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices |
| BS EN 1283:1996 | Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits |
| BS EN 50103:1996 | 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 |
| BS EN 554:1994 | Sterilization of medical devices. Validation and routine control of sterilization by moist heat |
| BS EN 928:1996 | Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices |
| BS EN 550:1994 | Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization |
| EN ISO 9002:1994/AC:1997 | QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION |
| EN ISO 8402 : 1995 | QUALITY MANAGEMENT AND QUALITY ASSURANCE - VOCABULARY |
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