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BS EN 724:1995

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices
Available format(s)

Hardcopy , PDF

Withdrawn date

28-09-2007

Language(s)

English

Published date

15-04-1995

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Withdrawn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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