I.S. 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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
08-06-2005
English
26-09-1995
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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
Provides guidance on the establishment and maintenance of the quality systems specified in I.S. EN ISO 9001/I.S. EN 46001 or I.S. EN ISO 9002/I.S. EN 46002 for the manufacture of non-active medical devices.
| DocumentType |
Standard
|
| Pages |
46
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| Standards | Relationship |
| UNE-EN 724:1995 | Identical |
| NEN EN 724 : 1994 | Identical |
| UNI EN 724 : 1996 | Identical |
| EN 724 : 1994 | Identical |
| NF EN 724 : 1995 | Identical |
| BS EN 724:1995 | Identical |
| NBN EN 724 : 1995 | Identical |
| SN EN 724 : 1995 | Identical |
| NS EN 724 : 1ED 1995 | Identical |
| DIN EN 724:1994-12 | Identical |
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