BS EN 724:1995
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 non-active medical devices
Hardcopy , PDF
09-28-2007
English
04-15-1995
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Committees responsible
National foreword
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) Guidance on elements of quality
systems relevant to sterile product manufacture
Annex B (informative) Features of job descriptions
of key individuals
Annex C (informative) Bibliography
Gives advice on the establishment and maintenance of the quality systems specified in EN 29001/EN 46001 or EN 29002/EN 46002 for the manufacture of non-active medical devices. Coverage includes: management responsibility, contract review, design control, purchasing, process control, quality records, internal quality audits, corrective action, and control of nonconforming product. Also gives detailed definitions and annexes.
| Committee |
CH/210/1
|
| DevelopmentNote |
Supersedes 92/52898 DC (08/2005)
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| NBN EN 724 : 1995 | Identical |
| NS EN 724 : 1ED 1995 | Identical |
| NEN EN 724 : 1994 | Identical |
| UNI EN 724 : 1996 | Identical |
| NF EN 724 : 1995 | Identical |
| SN EN 724 : 1995 | Identical |
| UNE-EN 724:1995 | Identical |
| I.S. EN 724:1995 | Identical |
| EN 724 : 1994 | Identical |
| DIN EN 724:1994-12 | Identical |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| EN 540 : 1993 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS |
| BS 5750-2:1987 | Quality systems Specification for production and installation |
| 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 |
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